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

December 18, 2006
June 6, 2011
June 2006
December 2010   (final data collection date for primary outcome measure)
to evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00412828 on ClinicalTrials.gov Archive Site
  • 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 ]
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A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma
A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Unresectable Stage III or Stage IV Melanoma
Drug: CR011-vcMMAE
administered as an intravenous infusion of 250 mL over 90 min
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
117
May 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00412828
CR011-CLN-11
Yes
Vice President, Clinical Development, Celldex Therapeutics
CuraGen Corporation
Not Provided
Not Provided
CuraGen Corporation
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP