Laurence Katznelson
A multicenter, randomized, blinded study to assess safety and efficacy of pasireotide LAR vs. octreotide LAR in patients with active acromegaly
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
Study CSOM230C2305 is therefore designed to further assess the safety and efficacy of pasireotide LAR vs. octreotide LAR in patients with active acromegaly. Pasireotide (SOM230) is a novel cyclohexapeptide somatostatin analogue. This will be a multicenter, randomized, blinded study. After the screening period, patients who fulfill the entrance criteria will be randomly assigned on a 1:1 basis to either the pasireotide LAR treatment arm or to the octreotide LAR treatment arm in each of the following two strata: 1) patients who have undergone a first surgery but are still medical treatment na?ve or 2) de-novo patients who present with a visible adenoma on MRI and who refuse pituitary surgery or for whom pituitary surgery is contraindicated. Patients will be treated with pasireotide LAR or octreotide LAR for 12 months. At the end of the 12 month treatment assignment period, patients? treatment will be unblinded.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Pasireotide LAR
- Drug: Octreotide LAR
Phase:
Phase 3Eligibility
Ages Eligible for Study:
Any Age 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:
Male or female patients of at least 18 years of age
? Patients with active acromegaly demonstrated by:
? a lack of suppression of GH nadir to < 1 μg/L after an oral tolerance
test with 75 g of glucose (oGTT) (not applicable for diabetic patients)
or a mean GH concentration of a 5-point profile within a 2 hour time period of > 5 μg/L
? an elevated circulating IGF-1 concentration (age and sex adjusted)
? Patients who have undergone a first surgery, but are still medical treatment na?ve, or
De-novo patients who present with a visible adenoma on MRI and who
refuse pituitary surgery or for whom pituitary surgery is contraindicated
? Patients with a known history of impaired fasting glucose or diabetes
mellitus may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary
? Patients for whom written informed consent to participate in the study has
been obtained prior to any study related activity
Key Exclusion Criteria:
Patients who are being or were treated with octreotide, lanreotide, dopamine agonists or GH antagonists
? De-novo patients not having an adenoma visible on MRI
? Patients who have received pasireotide (SOM230) prior to randomization
? Patients with compression of the optic chiasm causing any visual field defect
? Patients who require a surgical intervention for relief of any sign or
symptom associated with tumor compression
? Patients who have undergone major surgery/surgical therapy for any cause within 4 weeks of visit 1
? Patients who have received radiotherapy (except pituitary irradiation) for any reason within 4 weeks of visit 1 must have recovered from any side
effect of radiotherapy
? Patients who have received pituitary irradiation within the last ten years
prior to visit 1
? Patients who are hypothyroid and not adequately treated with stable doses of thyroid hormone replacement therapy
? Diabetic patients on antidiabetic medications whose fasting blood glucose
is poorly controlled as evidenced by HbA1c >8%
? Patients with symptomatic cholelithiasis
? Patients with abnormal coagulation (PT and/or APTT elevated by 30% above normal limits) or patients receiving anticoagulants that affect PT
(prothrombin time) or APTT (activated partial thromboplastin time)
? Patients who have congestive heart failure (NYHA Class III or IV),
unstable angina, sustained ventricular tachycardia, ventricular fibrillation,
clinically significant bradycardia, advanced heart block or a history of
acute myocardial infarction within the six months preceding enrollment
? Patients with risk factors for torsades de pointes, i.e. patients with a baseline QTc > 450 ms, hypokalemia, hypomagnesemia, hypocalcemia,
family history of long QT syndrome, and taking concomitant medications known to prolong QT interval
? Patients with confirmed central hypothyroidism, central hypoadrenalism,
central hypogonadism and diabetes insipidus, unless they are adequately
treated with stable doses of hormone replacement therapy for a minimum
of three months prior to study entry (first dose of study medication)
? Patients with liver disease such as cirrhosis, chronic active hepatitis or
chronic persistent hepatitis, or patients with ALT and/or AST more than 2 x ULN, serum creatinine > 2.0 x ULN, serum bilirubin > 2 x ULN, serum albumin < 0.67 x LLN
? Patients with WBC <3 x 109/L; Hgb < LLN; PLT <100 x 109/L
Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the
opinion of the Investigator or the Sponsor?s Medical Monitor
? Female patients who are pregnant or lactating, or are of childbearing
potential and not practicing a medically acceptable method of birth control. Female patients must use barrier contraception with condoms. If oral contraception is used in addition to condoms, the patient must have
been practicing this method for at least two months prior to the enrollment
and must agree to continue the oral contraceptive throughout the course
of the study and for 3 months after the study has ended. Male patients who are sexually active are required to use condoms during the study and for three month afterwards as a precautionary measure (available data do not suggest any increased reproductive risk with the study drugs)
? History of immunocompromise, including a positive HIV test result (ELISA
and Western blot). A HIV test will not be required; however, previous medical history will be reviewed
? Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to first dosing
? Known hypersensitivity to somatostatin analogues or any other component of the pasireotide LAR or octreotide LAR formulations
? Patients with active malignant disease within the last five years (with the
exception of basal cell carcinoma or carcinoma in situ of the cervix)
? Patients with the presence of active or suspected acute or chronic uncontrolled infection
? Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire
study
? Patients with a history of alcohol or drug abuse in the 6 month period prior
to receiving the study drug
Additional Study Details
Official Title:
A multicenter, randomized, blinded study to assess safety and efficacy of pasireotide LAR vs. octreotide LAR in patients with active acromegalyAnticipated start date:
4/22/2008Lead Sponsor:
Novartis PharmaceuticalsInvestigator(s):
- Laurence Katznelson
- Lakshmi Srinivasan
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- proportion of patients with a reduction of mean GH level to <2.5 ?g/L and
Secondary Outcomes:
- GH response alone
- tumor volume change
- IGF-1 response alone
- safety labs and AE
Total Number to be Enrolled:
330Total Number to be Enrolled at Stanford:
3More Information
Secondary ID(s):
- e-protocol 11614
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:
8/7/2008PLEASE 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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