A Study of DEDN6526A in Patients With Metastatic or Unresectable Melanoma

This study has been completed.
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
First received: January 20, 2012
Last updated: February 1, 2016
Last verified: February 2016
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 DEDN6526A by intravenous infusion on Day 1 of each 21-day cycle. In the absence of disease progression or unacceptable toxicity, patients may continue to receive DEDN6552A for up to 17 cycles (1 year).

Condition Intervention Phase
Malignant Melanoma
Drug: DEDN6526A
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DEDN6526A in Patients With Metastatic or Unresectable Melanoma

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: assessed on an ongoing basis and up to 90 days following last dose of study treatment ] [ Designated as safety issue: Yes ]
  • Maximum tolerated dose/dose-limiting toxicities [ Time Frame: approximately one year after study start ] [ Designated as safety issue: Yes ]
  • Determination of recommended Phase II dose [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: Area under the concentration-time curve [ Time Frame: Pre-dose, 30 min. and 4, 24, 48 hours post-dose and Days 7, 10, 15, 17 Cycles 1-4, pre-dose and 30 min. post-dose Cycle 5 and every other cycle thereafter ] [ Designated as safety issue: No ]
  • Anti-therapeutic antibody (ATA) levels [ Time Frame: Pre-dose Day 1 Cycles 1-4, and within 30 days post last dose ] [ Designated as safety issue: No ]
  • Tumor response (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 1 year ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: March 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single group Drug: DEDN6526A
Multiple ascending doses


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01522664

United States, California
Los Angeles, California, United States, 90025
United States, Florida
Sarasota, Florida, United States, 34232
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Tennessee
Nashville, Tennessee, United States, 37203
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
East Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Genentech, Inc.
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01522664     History of Changes
Other Study ID Numbers: GO27935 
Study First Received: January 20, 2012
Last Updated: February 1, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on May 30, 2016