Status:
COMPLETED
A Study of DEDN6526A in Patients With Metastatic or Unresectable Melanoma
Lead Sponsor:
Genentech, Inc.
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This multicenter, open-label study will assess the safety and pharmacokinetics of DEDN6526A in patients with metastatic or unresectable melanoma. Cohorts of patients will receive escalating doses of D...
Eligibility Criteria
Inclusion
- Adult patients, \>/= 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically confirmed metastatic melanoma (AJCC stage IV) or unresectable melanoma (AJCC Stage III)
- Prior failure of \>/= 1 prior treatment regimens for metastatic or unresectable melanoma due to disease progression or unacceptable toxicity and for whom no standard therapy is available
- Measurable disease according to RECIST criteria
- Adequate bone marrow, liver and renal function
- Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception through the course of the study treatment and for 6 months after the last dose of study treatment
Exclusion
- Treatment with cytotoxic or antibody based therapy within 21 days prior to first dose of study treatment, or with any other anti-cancer therapy within 5 half-lives of the therapy prior to first dose of study treatment
- Known active infection (including HIV and atypical mycobacterial disease, but excluding fungal infection of the nail beds)
- Current Grad \>/= 2 toxicity (except alopecia or anorexia) from prior therapy
- Grade \>/= 2 peripheral neuropathy
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapies (or recombinant antibody-related fusion proteins)
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
- Evidence of significant uncontrolled concomitant disease or disorder
- Pregnant or lactating women
- Prior treatment with any other antibody-drug conjugate (ADC) compound containing monomethyl auristatin E (MMAE) for the treatment of melanoma
- Previous participation in a clinical trial within 30 days of the day of first study drug administration (Cycle 1, Day 1)
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01522664
Start Date
March 1 2012
End Date
June 1 2015
Last Update
November 2 2016
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Los Angeles, California, United States, 90025
2
Sarasota, Florida, United States, 34232
3
Detroit, Michigan, United States, 48201
4
Nashville, Tennessee, United States, 37203