NCT00412828

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

February 19, 2015

Status Verified

February 1, 2015

Enrollment Period

4.5 years

First QC Date

December 18, 2006

Last Update Submit

February 2, 2015

Conditions

Unresectable Stage III or Stage IV Melanoma

Keywords

MelanomaCR011-vcMMAE

Outcome Measures

Primary Outcomes (1)

  • to evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT)

    throughout the study

Secondary Outcomes (3)

  • to evaluate the immune response to CR011-vcMMAE

    throughout the study

  • to assess the pharmacodynamics and pharmacokinetics of CRO11-vcMMAE

    throughout the study

  • to explore clinical anti-tumor response of CR011-vcMMAE in subjects with advanced metastatic melanoma

    throughout the study

Interventions

CR011-vcMMAEDRUG

administered as an intravenous infusion of 250 mL over 90 min

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Angeles Clinic and Research Institute

Santa Monica, California, 90404, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Ott PA, Hamid O, Pavlick AC, Kluger H, Kim KB, Boasberg PD, Simantov R, Crowley E, Green JA, Hawthorne T, Davis TA, Sznol M, Hwu P. Phase I/II study of the antibody-drug conjugate glembatumumab vedotin in patients with advanced melanoma. J Clin Oncol. 2014 Nov 10;32(32):3659-66. doi: 10.1200/JCO.2013.54.8115. Epub 2014 Sep 29.

    PMID: 25267741RESULT

Related Links

MeSH Terms

Conditions

Melanoma

Interventions

CR011-vcMMAE

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2006

First Posted

December 19, 2006

Study Start

June 1, 2006

Primary Completion

December 1, 2010

Study Completion

May 1, 2011

Last Updated

February 19, 2015

Record last verified: 2015-02

Locations

US(4)