Beverly S. Mitchell, M.D.
Trial of AVN-944 in Patients With Advanced Hematologic Malignancies
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of this study is to determine the safety and maximum tolerated dose, pharmacokinetics, and anti-neoplastic response of AVN-944 in patients with advanced hematologic malignancies.
Recruiting Status:
CompletedStanford Recruiting Status:
CompletedIntervention(s):
- Drug: AVN-944 capsules for oral administration
Phase:
Phase 1Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1) Histologically or cytologically confirmed chronic myelogenous leukemia, chronic lymphocytic leukemia, acute myeloid leukemia, acute lymphocytic leukemia, multiple myeloma, Waldenstrom's macroglobulinemia, non-Hodgkin's lymphoma or Hodgkin's disease.
Patients must be refractory to, intolerant of, or decline to receive established therapy known to provide clinical benefit for their condition.
3) Age > 18 years
4) ECOG performance score of 0 or 1
5) Adequate renal function as evidenced by serum creatinine < 2.0 mg/dL
6) Adequate hepatic function as evidenced by:
o Serum total bilirubin < 2.0 mg/dL (Patients with known Gilbert's syndrome may have total bilirubin values of up to 3 mg/dL.)
o Alkaline phosphatase < 3X the upper limit of normal (ULN) for the reference lab (< 5X the ULN if considered related to underlying disease)
o SGOT/SGPT < 3X the ULN for the reference lab (< 5X the ULN if considered related to underlying disease
7) Patients must be recovered from the clinically significant effects of any prior surgery, radiotherapy or other antineoplastic therapy.
8) Patients or their legal representatives must be able to read, understand and provide written informed consent to participate in the trial.
9) Women of childbearing potential as well as fertile men and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method).
Key Exclusion Criteria:
1) Patients with an uncontrolled active infection
2) Prior treatment with an inosine-5-monophosphate dehydrogenase (IMPDH)-inhibitor
3) History of prior malignancy within the past 5 years except for curatively treated non-melanoma skin cancers, cervical intra-epithelial neoplasia, or localized prostate cancer with a current prostate specific antigen (PSA) of < 1.0 mg/dL Patients with other curatively treated malignancies who have no evidence of metastatic disease may be entered after discussion with the Medical Monitor.
4) Patients with known hypersensitivity to any of the components of AVN-944
5) Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 14 days of the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication). Clinically significant toxicities from this therapy must have resolved to < Grade 2.
6) Grade 2 peripheral neuropathy
7) Patients who are pregnant or lactating
8) Any other intercurrent medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign the informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
9) History of solid organ transplant
10) Known HIV or hepatitis B or C (active, previously treated or both)
Additional Study Details
Official Title:
A Phase I Trial of AVN-944 in Patients With Advanced Hematologic MalignanciesAnticipated start date:
2/22/2006Lead Sponsor:
Avalon PharmaceuticalsCollaborator(s):
- Leukemia & Lymphoma Society
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- To determine the safety and maximum tolerated dose, pharmacokinetics, and anti-neoplastic response of AVN-944 in patients with advanced hematologic malignancies.
Total Number to be Enrolled:
72Total Number to be Enrolled at Stanford:
24More Information
Secondary ID(s):
- 96513
- AVN-944-002
- HEM0003
- NCT00273936
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
5/21/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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