A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma

This study has been completed.

Sponsor:

Information provided by:

CuraGen Corporation

ClinicalTrials.gov Identifier:

NCT00412828

First received: December 18, 2006

Last updated: June 6, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	December 18, 2006
Last Updated Date	June 6, 2011
Start Date ^ICMJE	June 2006
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 2, 2008)	to evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00412828 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 2, 2008)	to evaluate the immune response to CR011-vcMMAE [ Time Frame: throughout the study ] [ Designated as safety issue: No ] to assess the pharmacodynamics and pharmacokinetics of CRO11-vcMMAE [ Time Frame: throughout the study ] [ Designated as safety issue: No ] to explore clinical anti-tumor response of CR011-vcMMAE in subjects with advanced metastatic melanoma [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma
Official Title ^ICMJE	A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma
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 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Unresectable Stage III or Stage IV Melanoma
Intervention ^ICMJE	Drug: CR011-vcMMAE administered as an intravenous infusion of 250 mL over 90 min
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	117
Completion Date	May 2011
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00412828
Other Study ID Numbers ^ICMJE	CR011-CLN-11
Has Data Monitoring Committee	Yes
Responsible Party	Vice President, Clinical Development, Celldex Therapeutics
Study Sponsor ^ICMJE	CuraGen Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	CuraGen Corporation
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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