Clinical Trials Unit
Stanford University School of Medicine's Center for Advanced Dermatologic Investigation is the Dermatology Department's clinical trials unit.
The Center is home to 12-15 ongoing clinical studies, investigating the safety and efficacy of new and currently available drugs and over-the-counter medications. The Center works with Stanford's own panel on medical research, leading pharmaceutical companies,and the Food and Drug Administration to safely and ethically expand the medical field's knowledge of dermatologic treatments. New studies begin regularly, and the Center continues to recruit patients with skin aging, sun damage, skin cancer (including basal cell carcinomas), psoriasis, atopic dermatitis, rosacea, and other dermatologic diseases for ongoing studies.
Skin Aging Studies
We seek to understand the human aging processes as it relates to skin on a fundamental level. To this end, our studies focus on clinical and translational research efforts ranging from: (1) the analysis of gene changes which predispose individuals to exceptionally youthful skin to (2) molecular signatures that may be biomarkers for aging skin to (3) the careful study of new candidate agents which might affect the skin aging process.
Nonmelanoma Skin Cancer
Recent advances in our understanding of basal cell skin cancer biology have enabled the development of cutting edge study drugs which combat tumor growth. We are currently home to a number of clinical trials at the forefront of potential therapy for advanced or metastatic basal cell cancer. In addition, we seek to understand the biology of basal cell skin cancers and to identify molecular predictors for treatment success.
Acne Rosecea
This is a common and frustrating chronic inflammatory condition of the face, usually affecting older individuals. The causes of this complex condition are the subject of much study. Our clinical studies seek to identify new topical or oral medications to improve the symptoms of acne rosacea.
Contact
For more information, please email dermtrials@stanford.edu
Featured Clinical Trials
A Study of AL102 in Patients With Progressing Desmoid Tumors
The current study is designed to evaluate the efficacy and safety of AL102 in patients with progressive desmoid tumors.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: AL102
- other: Placebo
Eligibility
Inclusion Criteria Part A:
1. At least 18 years of age (inclusive) at the time of signing the ICF.
2. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist
(prior to informed consent).
3. Disease progression, assessed locally by the investigator, defined as having at least
one of the following:
- Unidimensional growth of desmoid tumor(s) by ≥10%, using the sum of the largest
diameters of target lesion(s), within 18 months of the screening MRI
- Having desmoid tumor-related pain that is not adequately controlled with
nonopioid medication
4. At least 1 measurable lesion amenable to volume measurements by MRI at screening (Part
A only)
5. One of the following:
- Treatment naïve subjects for whom, in the opinion of the investigator, the IP is
deemed appropriate, OR
- Recurrent/refractory disease following at least one line of therapy (including
surgery, radiation, or systemic therapy)
6. Agrees to provide formalin-fixed paraffin embedded archival or fresh tumor tissue for
re- confirmation of disease.
7. Must be able to swallow whole capsules with no GI condition affecting absorption;
nasogastric or G-tube administration is not allowed.
Exclusion Criteria Part A:
1. Diagnosed with a malignancy in the past 2 years with some exceptions.
2. Current or recent (within 2 months of IP administration) GI disease or disorders that
increase the risk of diarrhea, such as inflammatory bowel disease and Crohn's disease.
3. Evidence of uncontrolled, active infection, requiring systemic anti-bacterial,
anti-viral or anti- fungal therapy ≤7 days prior to administration of IP such as known
active infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
at Screening.
4. Myocardial infarction within 6 months prior to enrollment, greater than Class 1 angina
pectoris, or has New York Heart Association (NYHA) Class III or IV heart failure, ,
symptomatic ventricular arrhythmias, sustained ventricular tachycardia, Torsade's de
Pointes (TdP), the long QT syndrome, pacemaker dependence, or electrocardiographic
evidence of acute ischemia.
5. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac or pulmonary
function or uncontrolled diabetes) or any important medical illness or abnormal
laboratory finding that would, in the investigator's judgment, increase the risk to
the subject associated with his or her participation in the study.
6. Pregnant or breastfeeding or expecting to conceive children within the projected
duration of the study.
7. Eastern Cooperative Oncology Group (ECOG) performance status ≥2
8. Abnormal organ and marrow function at Screening defined as:
1. Neutrophils <1000/mm3,
2. Platelet count <100,000/mm3,
3. Hemoglobin <9 g/dL,
4. Total bilirubin >1.5x upper limit of normal (ULN) (except known Gilbert's
syndrome),
5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5x ULN,
6. Serum creatinine > ULN and creatinine clearance (CrCl) <60 mL/min (calculation of
CrCl will be based on acceptable institution standard)
7. Uncontrolled triglyceride ≥Grade 2 elevations per common terminology criteria for
adverse events (CTCAE) v5.0 (>300 mg/dL or >3.42 mmol/L).
9. ECG Exclusions (Part A only)
1. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥450
msec.
2. QRS duration > 110 ms
3. PR interval > 240 ms
4. Marked ST-T wave abnormalities which would make it difficult to measure the QT
interval
10. Any treatments for desmoid tumors within 4 weeks prior to first dose of
investigational therapy; subject must have recovered from therapy related toxicity to
< CTCAE Grade 2 or clinical baseline. Therapy includes:
1. Locoregional tumor directed therapies such as major surgery, radiation,
radiofrequency ablation, or cryosurgery
2. Systemic therapy including chemotherapy, biologic (anti-neoplastic agent,
antibodies), TKIs (e.g., sorafenib, pazopanib, imatinib), hormonal therapy, or
investigational therapy
11. Chronic NSAIDs for the treatment of desmoid tumors within 4 weeks of first dose of IP;
Inclusion Criteria Part B
1. ≥12 years of age (inclusive) and ≥ 40 kg at the time of signing the ICF.
2. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist
(prior to informed consent) that has progressed by ≥ 20% as measured by RECIST v1.1
within 12 months of the screening visit scan.
3. Evidence of measurable disease by CT/MRI scan. Measurable lesions are defined
according to RECIST v1.1.
4. Subject and/or legally authorized representative (i.e. parent/guardian) must be
capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the ICF.
5. Minor subjects must be capable of giving written assent as appropriate per the
applicable age (per local regulatory requirements).
For all other inclusion criteria refer to Part A inclusion criteria.
Exclusion Criteria Part B The subjects must be excluded from participating in the study if
they meet any of the exclusion criteria for Part A, except where otherwise noted.
Ages Eligible for Study
12 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Ileana Aguilar Torres
ileanaa@stanford.edu
I'm interested
Psoriasis Clinical Trials
A Study of AL102 in Patients With Progressing Desmoid Tumors
The current study is designed to evaluate the efficacy and safety of AL102 in patients with progressive desmoid tumors.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: AL102
- other: Placebo
Eligibility
Inclusion Criteria Part A:
1. At least 18 years of age (inclusive) at the time of signing the ICF.
2. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist
(prior to informed consent).
3. Disease progression, assessed locally by the investigator, defined as having at least
one of the following:
- Unidimensional growth of desmoid tumor(s) by ≥10%, using the sum of the largest
diameters of target lesion(s), within 18 months of the screening MRI
- Having desmoid tumor-related pain that is not adequately controlled with
nonopioid medication
4. At least 1 measurable lesion amenable to volume measurements by MRI at screening (Part
A only)
5. One of the following:
- Treatment naïve subjects for whom, in the opinion of the investigator, the IP is
deemed appropriate, OR
- Recurrent/refractory disease following at least one line of therapy (including
surgery, radiation, or systemic therapy)
6. Agrees to provide formalin-fixed paraffin embedded archival or fresh tumor tissue for
re- confirmation of disease.
7. Must be able to swallow whole capsules with no GI condition affecting absorption;
nasogastric or G-tube administration is not allowed.
Exclusion Criteria Part A:
1. Diagnosed with a malignancy in the past 2 years with some exceptions.
2. Current or recent (within 2 months of IP administration) GI disease or disorders that
increase the risk of diarrhea, such as inflammatory bowel disease and Crohn's disease.
3. Evidence of uncontrolled, active infection, requiring systemic anti-bacterial,
anti-viral or anti- fungal therapy ≤7 days prior to administration of IP such as known
active infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
at Screening.
4. Myocardial infarction within 6 months prior to enrollment, greater than Class 1 angina
pectoris, or has New York Heart Association (NYHA) Class III or IV heart failure, ,
symptomatic ventricular arrhythmias, sustained ventricular tachycardia, Torsade's de
Pointes (TdP), the long QT syndrome, pacemaker dependence, or electrocardiographic
evidence of acute ischemia.
5. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac or pulmonary
function or uncontrolled diabetes) or any important medical illness or abnormal
laboratory finding that would, in the investigator's judgment, increase the risk to
the subject associated with his or her participation in the study.
6. Pregnant or breastfeeding or expecting to conceive children within the projected
duration of the study.
7. Eastern Cooperative Oncology Group (ECOG) performance status ≥2
8. Abnormal organ and marrow function at Screening defined as:
1. Neutrophils <1000/mm3,
2. Platelet count <100,000/mm3,
3. Hemoglobin <9 g/dL,
4. Total bilirubin >1.5x upper limit of normal (ULN) (except known Gilbert's
syndrome),
5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5x ULN,
6. Serum creatinine > ULN and creatinine clearance (CrCl) <60 mL/min (calculation of
CrCl will be based on acceptable institution standard)
7. Uncontrolled triglyceride ≥Grade 2 elevations per common terminology criteria for
adverse events (CTCAE) v5.0 (>300 mg/dL or >3.42 mmol/L).
9. ECG Exclusions (Part A only)
1. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥450
msec.
2. QRS duration > 110 ms
3. PR interval > 240 ms
4. Marked ST-T wave abnormalities which would make it difficult to measure the QT
interval
10. Any treatments for desmoid tumors within 4 weeks prior to first dose of
investigational therapy; subject must have recovered from therapy related toxicity to
< CTCAE Grade 2 or clinical baseline. Therapy includes:
1. Locoregional tumor directed therapies such as major surgery, radiation,
radiofrequency ablation, or cryosurgery
2. Systemic therapy including chemotherapy, biologic (anti-neoplastic agent,
antibodies), TKIs (e.g., sorafenib, pazopanib, imatinib), hormonal therapy, or
investigational therapy
11. Chronic NSAIDs for the treatment of desmoid tumors within 4 weeks of first dose of IP;
Inclusion Criteria Part B
1. ≥12 years of age (inclusive) and ≥ 40 kg at the time of signing the ICF.
2. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist
(prior to informed consent) that has progressed by ≥ 20% as measured by RECIST v1.1
within 12 months of the screening visit scan.
3. Evidence of measurable disease by CT/MRI scan. Measurable lesions are defined
according to RECIST v1.1.
4. Subject and/or legally authorized representative (i.e. parent/guardian) must be
capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the ICF.
5. Minor subjects must be capable of giving written assent as appropriate per the
applicable age (per local regulatory requirements).
For all other inclusion criteria refer to Part A inclusion criteria.
Exclusion Criteria Part B The subjects must be excluded from participating in the study if
they meet any of the exclusion criteria for Part A, except where otherwise noted.
Ages Eligible for Study
12 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Ileana Aguilar Torres
ileanaa@stanford.edu
I'm interested
Dermatology Clinical Trials
A Study of AL102 in Patients With Progressing Desmoid Tumors
The current study is designed to evaluate the efficacy and safety of AL102 in patients with progressive desmoid tumors.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: AL102
- other: Placebo
Eligibility
Inclusion Criteria Part A:
1. At least 18 years of age (inclusive) at the time of signing the ICF.
2. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist
(prior to informed consent).
3. Disease progression, assessed locally by the investigator, defined as having at least
one of the following:
- Unidimensional growth of desmoid tumor(s) by ≥10%, using the sum of the largest
diameters of target lesion(s), within 18 months of the screening MRI
- Having desmoid tumor-related pain that is not adequately controlled with
nonopioid medication
4. At least 1 measurable lesion amenable to volume measurements by MRI at screening (Part
A only)
5. One of the following:
- Treatment naïve subjects for whom, in the opinion of the investigator, the IP is
deemed appropriate, OR
- Recurrent/refractory disease following at least one line of therapy (including
surgery, radiation, or systemic therapy)
6. Agrees to provide formalin-fixed paraffin embedded archival or fresh tumor tissue for
re- confirmation of disease.
7. Must be able to swallow whole capsules with no GI condition affecting absorption;
nasogastric or G-tube administration is not allowed.
Exclusion Criteria Part A:
1. Diagnosed with a malignancy in the past 2 years with some exceptions.
2. Current or recent (within 2 months of IP administration) GI disease or disorders that
increase the risk of diarrhea, such as inflammatory bowel disease and Crohn's disease.
3. Evidence of uncontrolled, active infection, requiring systemic anti-bacterial,
anti-viral or anti- fungal therapy ≤7 days prior to administration of IP such as known
active infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
at Screening.
4. Myocardial infarction within 6 months prior to enrollment, greater than Class 1 angina
pectoris, or has New York Heart Association (NYHA) Class III or IV heart failure, ,
symptomatic ventricular arrhythmias, sustained ventricular tachycardia, Torsade's de
Pointes (TdP), the long QT syndrome, pacemaker dependence, or electrocardiographic
evidence of acute ischemia.
5. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac or pulmonary
function or uncontrolled diabetes) or any important medical illness or abnormal
laboratory finding that would, in the investigator's judgment, increase the risk to
the subject associated with his or her participation in the study.
6. Pregnant or breastfeeding or expecting to conceive children within the projected
duration of the study.
7. Eastern Cooperative Oncology Group (ECOG) performance status ≥2
8. Abnormal organ and marrow function at Screening defined as:
1. Neutrophils <1000/mm3,
2. Platelet count <100,000/mm3,
3. Hemoglobin <9 g/dL,
4. Total bilirubin >1.5x upper limit of normal (ULN) (except known Gilbert's
syndrome),
5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5x ULN,
6. Serum creatinine > ULN and creatinine clearance (CrCl) <60 mL/min (calculation of
CrCl will be based on acceptable institution standard)
7. Uncontrolled triglyceride ≥Grade 2 elevations per common terminology criteria for
adverse events (CTCAE) v5.0 (>300 mg/dL or >3.42 mmol/L).
9. ECG Exclusions (Part A only)
1. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥450
msec.
2. QRS duration > 110 ms
3. PR interval > 240 ms
4. Marked ST-T wave abnormalities which would make it difficult to measure the QT
interval
10. Any treatments for desmoid tumors within 4 weeks prior to first dose of
investigational therapy; subject must have recovered from therapy related toxicity to
< CTCAE Grade 2 or clinical baseline. Therapy includes:
1. Locoregional tumor directed therapies such as major surgery, radiation,
radiofrequency ablation, or cryosurgery
2. Systemic therapy including chemotherapy, biologic (anti-neoplastic agent,
antibodies), TKIs (e.g., sorafenib, pazopanib, imatinib), hormonal therapy, or
investigational therapy
11. Chronic NSAIDs for the treatment of desmoid tumors within 4 weeks of first dose of IP;
Inclusion Criteria Part B
1. ≥12 years of age (inclusive) and ≥ 40 kg at the time of signing the ICF.
2. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist
(prior to informed consent) that has progressed by ≥ 20% as measured by RECIST v1.1
within 12 months of the screening visit scan.
3. Evidence of measurable disease by CT/MRI scan. Measurable lesions are defined
according to RECIST v1.1.
4. Subject and/or legally authorized representative (i.e. parent/guardian) must be
capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the ICF.
5. Minor subjects must be capable of giving written assent as appropriate per the
applicable age (per local regulatory requirements).
For all other inclusion criteria refer to Part A inclusion criteria.
Exclusion Criteria Part B The subjects must be excluded from participating in the study if
they meet any of the exclusion criteria for Part A, except where otherwise noted.
Ages Eligible for Study
12 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Ileana Aguilar Torres
ileanaa@stanford.edu
I'm interested
Pediatric Dermatology Clinical Trials
A Study of AL102 in Patients With Progressing Desmoid Tumors
The current study is designed to evaluate the efficacy and safety of AL102 in patients with progressive desmoid tumors.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: AL102
- other: Placebo
Eligibility
Inclusion Criteria Part A:
1. At least 18 years of age (inclusive) at the time of signing the ICF.
2. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist
(prior to informed consent).
3. Disease progression, assessed locally by the investigator, defined as having at least
one of the following:
- Unidimensional growth of desmoid tumor(s) by ≥10%, using the sum of the largest
diameters of target lesion(s), within 18 months of the screening MRI
- Having desmoid tumor-related pain that is not adequately controlled with
nonopioid medication
4. At least 1 measurable lesion amenable to volume measurements by MRI at screening (Part
A only)
5. One of the following:
- Treatment naïve subjects for whom, in the opinion of the investigator, the IP is
deemed appropriate, OR
- Recurrent/refractory disease following at least one line of therapy (including
surgery, radiation, or systemic therapy)
6. Agrees to provide formalin-fixed paraffin embedded archival or fresh tumor tissue for
re- confirmation of disease.
7. Must be able to swallow whole capsules with no GI condition affecting absorption;
nasogastric or G-tube administration is not allowed.
Exclusion Criteria Part A:
1. Diagnosed with a malignancy in the past 2 years with some exceptions.
2. Current or recent (within 2 months of IP administration) GI disease or disorders that
increase the risk of diarrhea, such as inflammatory bowel disease and Crohn's disease.
3. Evidence of uncontrolled, active infection, requiring systemic anti-bacterial,
anti-viral or anti- fungal therapy ≤7 days prior to administration of IP such as known
active infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
at Screening.
4. Myocardial infarction within 6 months prior to enrollment, greater than Class 1 angina
pectoris, or has New York Heart Association (NYHA) Class III or IV heart failure, ,
symptomatic ventricular arrhythmias, sustained ventricular tachycardia, Torsade's de
Pointes (TdP), the long QT syndrome, pacemaker dependence, or electrocardiographic
evidence of acute ischemia.
5. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac or pulmonary
function or uncontrolled diabetes) or any important medical illness or abnormal
laboratory finding that would, in the investigator's judgment, increase the risk to
the subject associated with his or her participation in the study.
6. Pregnant or breastfeeding or expecting to conceive children within the projected
duration of the study.
7. Eastern Cooperative Oncology Group (ECOG) performance status ≥2
8. Abnormal organ and marrow function at Screening defined as:
1. Neutrophils <1000/mm3,
2. Platelet count <100,000/mm3,
3. Hemoglobin <9 g/dL,
4. Total bilirubin >1.5x upper limit of normal (ULN) (except known Gilbert's
syndrome),
5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5x ULN,
6. Serum creatinine > ULN and creatinine clearance (CrCl) <60 mL/min (calculation of
CrCl will be based on acceptable institution standard)
7. Uncontrolled triglyceride ≥Grade 2 elevations per common terminology criteria for
adverse events (CTCAE) v5.0 (>300 mg/dL or >3.42 mmol/L).
9. ECG Exclusions (Part A only)
1. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥450
msec.
2. QRS duration > 110 ms
3. PR interval > 240 ms
4. Marked ST-T wave abnormalities which would make it difficult to measure the QT
interval
10. Any treatments for desmoid tumors within 4 weeks prior to first dose of
investigational therapy; subject must have recovered from therapy related toxicity to
< CTCAE Grade 2 or clinical baseline. Therapy includes:
1. Locoregional tumor directed therapies such as major surgery, radiation,
radiofrequency ablation, or cryosurgery
2. Systemic therapy including chemotherapy, biologic (anti-neoplastic agent,
antibodies), TKIs (e.g., sorafenib, pazopanib, imatinib), hormonal therapy, or
investigational therapy
11. Chronic NSAIDs for the treatment of desmoid tumors within 4 weeks of first dose of IP;
Inclusion Criteria Part B
1. ≥12 years of age (inclusive) and ≥ 40 kg at the time of signing the ICF.
2. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist
(prior to informed consent) that has progressed by ≥ 20% as measured by RECIST v1.1
within 12 months of the screening visit scan.
3. Evidence of measurable disease by CT/MRI scan. Measurable lesions are defined
according to RECIST v1.1.
4. Subject and/or legally authorized representative (i.e. parent/guardian) must be
capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the ICF.
5. Minor subjects must be capable of giving written assent as appropriate per the
applicable age (per local regulatory requirements).
For all other inclusion criteria refer to Part A inclusion criteria.
Exclusion Criteria Part B The subjects must be excluded from participating in the study if
they meet any of the exclusion criteria for Part A, except where otherwise noted.
Ages Eligible for Study
12 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Ileana Aguilar Torres
ileanaa@stanford.edu
I'm interested
A Study of AL102 in Patients With Progressing Desmoid Tumors
The current study is designed to evaluate the efficacy and safety of AL102 in patients with progressive desmoid tumors.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: AL102
- other: Placebo
Eligibility
Inclusion Criteria Part A:
1. At least 18 years of age (inclusive) at the time of signing the ICF.
2. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist
(prior to informed consent).
3. Disease progression, assessed locally by the investigator, defined as having at least
one of the following:
- Unidimensional growth of desmoid tumor(s) by ≥10%, using the sum of the largest
diameters of target lesion(s), within 18 months of the screening MRI
- Having desmoid tumor-related pain that is not adequately controlled with
nonopioid medication
4. At least 1 measurable lesion amenable to volume measurements by MRI at screening (Part
A only)
5. One of the following:
- Treatment naïve subjects for whom, in the opinion of the investigator, the IP is
deemed appropriate, OR
- Recurrent/refractory disease following at least one line of therapy (including
surgery, radiation, or systemic therapy)
6. Agrees to provide formalin-fixed paraffin embedded archival or fresh tumor tissue for
re- confirmation of disease.
7. Must be able to swallow whole capsules with no GI condition affecting absorption;
nasogastric or G-tube administration is not allowed.
Exclusion Criteria Part A:
1. Diagnosed with a malignancy in the past 2 years with some exceptions.
2. Current or recent (within 2 months of IP administration) GI disease or disorders that
increase the risk of diarrhea, such as inflammatory bowel disease and Crohn's disease.
3. Evidence of uncontrolled, active infection, requiring systemic anti-bacterial,
anti-viral or anti- fungal therapy ≤7 days prior to administration of IP such as known
active infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
at Screening.
4. Myocardial infarction within 6 months prior to enrollment, greater than Class 1 angina
pectoris, or has New York Heart Association (NYHA) Class III or IV heart failure, ,
symptomatic ventricular arrhythmias, sustained ventricular tachycardia, Torsade's de
Pointes (TdP), the long QT syndrome, pacemaker dependence, or electrocardiographic
evidence of acute ischemia.
5. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac or pulmonary
function or uncontrolled diabetes) or any important medical illness or abnormal
laboratory finding that would, in the investigator's judgment, increase the risk to
the subject associated with his or her participation in the study.
6. Pregnant or breastfeeding or expecting to conceive children within the projected
duration of the study.
7. Eastern Cooperative Oncology Group (ECOG) performance status ≥2
8. Abnormal organ and marrow function at Screening defined as:
1. Neutrophils <1000/mm3,
2. Platelet count <100,000/mm3,
3. Hemoglobin <9 g/dL,
4. Total bilirubin >1.5x upper limit of normal (ULN) (except known Gilbert's
syndrome),
5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5x ULN,
6. Serum creatinine > ULN and creatinine clearance (CrCl) <60 mL/min (calculation of
CrCl will be based on acceptable institution standard)
7. Uncontrolled triglyceride ≥Grade 2 elevations per common terminology criteria for
adverse events (CTCAE) v5.0 (>300 mg/dL or >3.42 mmol/L).
9. ECG Exclusions (Part A only)
1. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥450
msec.
2. QRS duration > 110 ms
3. PR interval > 240 ms
4. Marked ST-T wave abnormalities which would make it difficult to measure the QT
interval
10. Any treatments for desmoid tumors within 4 weeks prior to first dose of
investigational therapy; subject must have recovered from therapy related toxicity to
< CTCAE Grade 2 or clinical baseline. Therapy includes:
1. Locoregional tumor directed therapies such as major surgery, radiation,
radiofrequency ablation, or cryosurgery
2. Systemic therapy including chemotherapy, biologic (anti-neoplastic agent,
antibodies), TKIs (e.g., sorafenib, pazopanib, imatinib), hormonal therapy, or
investigational therapy
11. Chronic NSAIDs for the treatment of desmoid tumors within 4 weeks of first dose of IP;
Inclusion Criteria Part B
1. ≥12 years of age (inclusive) and ≥ 40 kg at the time of signing the ICF.
2. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist
(prior to informed consent) that has progressed by ≥ 20% as measured by RECIST v1.1
within 12 months of the screening visit scan.
3. Evidence of measurable disease by CT/MRI scan. Measurable lesions are defined
according to RECIST v1.1.
4. Subject and/or legally authorized representative (i.e. parent/guardian) must be
capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the ICF.
5. Minor subjects must be capable of giving written assent as appropriate per the
applicable age (per local regulatory requirements).
For all other inclusion criteria refer to Part A inclusion criteria.
Exclusion Criteria Part B The subjects must be excluded from participating in the study if
they meet any of the exclusion criteria for Part A, except where otherwise noted.
Ages Eligible for Study
12 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Ileana Aguilar Torres
ileanaa@stanford.edu
I'm interested
A Study of AL102 in Patients With Progressing Desmoid Tumors
The current study is designed to evaluate the efficacy and safety of AL102 in patients with progressive desmoid tumors.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: AL102
- other: Placebo
Eligibility
Inclusion Criteria Part A:
1. At least 18 years of age (inclusive) at the time of signing the ICF.
2. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist
(prior to informed consent).
3. Disease progression, assessed locally by the investigator, defined as having at least
one of the following:
- Unidimensional growth of desmoid tumor(s) by ≥10%, using the sum of the largest
diameters of target lesion(s), within 18 months of the screening MRI
- Having desmoid tumor-related pain that is not adequately controlled with
nonopioid medication
4. At least 1 measurable lesion amenable to volume measurements by MRI at screening (Part
A only)
5. One of the following:
- Treatment naïve subjects for whom, in the opinion of the investigator, the IP is
deemed appropriate, OR
- Recurrent/refractory disease following at least one line of therapy (including
surgery, radiation, or systemic therapy)
6. Agrees to provide formalin-fixed paraffin embedded archival or fresh tumor tissue for
re- confirmation of disease.
7. Must be able to swallow whole capsules with no GI condition affecting absorption;
nasogastric or G-tube administration is not allowed.
Exclusion Criteria Part A:
1. Diagnosed with a malignancy in the past 2 years with some exceptions.
2. Current or recent (within 2 months of IP administration) GI disease or disorders that
increase the risk of diarrhea, such as inflammatory bowel disease and Crohn's disease.
3. Evidence of uncontrolled, active infection, requiring systemic anti-bacterial,
anti-viral or anti- fungal therapy ≤7 days prior to administration of IP such as known
active infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
at Screening.
4. Myocardial infarction within 6 months prior to enrollment, greater than Class 1 angina
pectoris, or has New York Heart Association (NYHA) Class III or IV heart failure, ,
symptomatic ventricular arrhythmias, sustained ventricular tachycardia, Torsade's de
Pointes (TdP), the long QT syndrome, pacemaker dependence, or electrocardiographic
evidence of acute ischemia.
5. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac or pulmonary
function or uncontrolled diabetes) or any important medical illness or abnormal
laboratory finding that would, in the investigator's judgment, increase the risk to
the subject associated with his or her participation in the study.
6. Pregnant or breastfeeding or expecting to conceive children within the projected
duration of the study.
7. Eastern Cooperative Oncology Group (ECOG) performance status ≥2
8. Abnormal organ and marrow function at Screening defined as:
1. Neutrophils <1000/mm3,
2. Platelet count <100,000/mm3,
3. Hemoglobin <9 g/dL,
4. Total bilirubin >1.5x upper limit of normal (ULN) (except known Gilbert's
syndrome),
5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5x ULN,
6. Serum creatinine > ULN and creatinine clearance (CrCl) <60 mL/min (calculation of
CrCl will be based on acceptable institution standard)
7. Uncontrolled triglyceride ≥Grade 2 elevations per common terminology criteria for
adverse events (CTCAE) v5.0 (>300 mg/dL or >3.42 mmol/L).
9. ECG Exclusions (Part A only)
1. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥450
msec.
2. QRS duration > 110 ms
3. PR interval > 240 ms
4. Marked ST-T wave abnormalities which would make it difficult to measure the QT
interval
10. Any treatments for desmoid tumors within 4 weeks prior to first dose of
investigational therapy; subject must have recovered from therapy related toxicity to
< CTCAE Grade 2 or clinical baseline. Therapy includes:
1. Locoregional tumor directed therapies such as major surgery, radiation,
radiofrequency ablation, or cryosurgery
2. Systemic therapy including chemotherapy, biologic (anti-neoplastic agent,
antibodies), TKIs (e.g., sorafenib, pazopanib, imatinib), hormonal therapy, or
investigational therapy
11. Chronic NSAIDs for the treatment of desmoid tumors within 4 weeks of first dose of IP;
Inclusion Criteria Part B
1. ≥12 years of age (inclusive) and ≥ 40 kg at the time of signing the ICF.
2. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist
(prior to informed consent) that has progressed by ≥ 20% as measured by RECIST v1.1
within 12 months of the screening visit scan.
3. Evidence of measurable disease by CT/MRI scan. Measurable lesions are defined
according to RECIST v1.1.
4. Subject and/or legally authorized representative (i.e. parent/guardian) must be
capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the ICF.
5. Minor subjects must be capable of giving written assent as appropriate per the
applicable age (per local regulatory requirements).
For all other inclusion criteria refer to Part A inclusion criteria.
Exclusion Criteria Part B The subjects must be excluded from participating in the study if
they meet any of the exclusion criteria for Part A, except where otherwise noted.
Ages Eligible for Study
12 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Ileana Aguilar Torres
ileanaa@stanford.edu
I'm interested