Status:
COMPLETED
A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma
Lead Sponsor:
CuraGen Corporation
Conditions:
Unresectable Stage III or Stage IV Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE in patients who have unresectable stage III or stage IV melanoma and have failed no more than 1 line of prior cyt...
Eligibility Criteria
Inclusion
- Male or female with age ≥ 18 years.
- Progressive or new metastatic melanoma, stage III or IV.
- Measurable disease by CT / MRI
- Failure of no more than 1 line of prior cytotoxic therapy.
- Adequate bone marrow, renal and hepatic function
- Leukocytes ≥ 3000/mm3, ANC ≥ 1,500 cells/mm3, Platelets ≥ 100,000/mm3
- Hemoglobin ≥ 10 g/dL (transfusion allowed)
- Total bilirubin ≤ 1.5 x upper normal limit (UNL)
- AST (SGOT), ALT (SGPT) ≤ 3.0 x UNL (≤ 5.0 x UNL may be acceptable)
- Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance \> 45 mL/min/1.73 m2
- PT/aPTT \< 1.5 x UNL or within therapeutic range via anti-coagulation therapy
- Karnofsky PS ≥ 70%.
- Estimated life expectancy \> 3 months.
- Signed informed consent approved IRB and ability to comply with the study or monitoring procedures.
- Subjects with evaluable disease are eligible in dose-escalation cohorts
Exclusion
- Prior therapies for disease under study less than 4 weeks prior to enrollment.
- Major surgery or trauma within 4 weeks of enrollment.
- Active brain metastases
- Active chronic inflammatory, autoimmunity, immunodeficiency disease, and vascular or hemorrhagic disorders.
- History of allergic reactions to dolastatin, auristatin or compounds of similar composition.
- Significant cardiovascular disease
- Other malignancies
- Pregnancy or breast feeding
- Refusal or inability to use effective means of contraception (for men, and women with childbearing potential)
- History of or test-positive to HIV, or hepatitis B or C
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00412828
Start Date
June 1 2006
End Date
May 1 2011
Last Update
February 19 2015
Active Locations (4)
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1
Angeles Clinic and Research Institute
Santa Monica, California, United States, 90404
2
Yale University
New Haven, Connecticut, United States, 06520
3
New York University Medical Center
New York, New York, United States, 10016
4
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030