- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00412828
A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma
February 2, 2015 updated by: CuraGen Corporation
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 cytotoxic therapy.
CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks at escalating doses until the maximum tolerated dose (MTD) is reached.
Once the MTD is defined, 18-32 patients will be enrolled to further evaluate the safety and efficacy of CR011-vcMMAE at this dose level.
Additional dosing schedules of CR011-vcMMAE will also be explored.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
117
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Santa Monica, California, United States, 90404
- Angeles Clinic and Research Institute
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale University
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New York
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New York, New York, United States, 10016
- New York University Medical Center
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Texas
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Houston, Texas, United States, 77030
- M.D. Anderson Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
to evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT)
Time Frame: throughout the study
|
throughout the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
to evaluate the immune response to CR011-vcMMAE
Time Frame: throughout the study
|
throughout the study
|
to assess the pharmacodynamics and pharmacokinetics of CRO11-vcMMAE
Time Frame: throughout the study
|
throughout the study
|
to explore clinical anti-tumor response of CR011-vcMMAE in subjects with advanced metastatic melanoma
Time Frame: throughout the study
|
throughout the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
December 18, 2006
First Submitted That Met QC Criteria
December 18, 2006
First Posted (Estimate)
December 19, 2006
Study Record Updates
Last Update Posted (Estimate)
February 19, 2015
Last Update Submitted That Met QC Criteria
February 2, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR011-CLN-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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