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A Study of DEDN6526A in Patients With Metastatic or Unresectable Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01522664
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Genentech, Inc.

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 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 or disease Intervention/treatment Phase
Malignant Melanoma Drug: DEDN6526A Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Single group Drug: DEDN6526A
Multiple ascending doses

Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: assessed on an ongoing basis and up to 90 days following last dose of study treatment ]
  2. Maximum tolerated dose/dose-limiting toxicities [ Time Frame: approximately one year after study start ]
  3. Determination of recommended Phase II dose [ Time Frame: approximately 2 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. Anti-therapeutic antibody (ATA) levels [ Time Frame: Pre-dose Day 1 Cycles 1-4, and within 30 days post last dose ]
  3. Tumor response (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01522664

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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.
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Study Director: Clinical Trials Genentech, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Genentech, Inc. Identifier: NCT01522664    
Other Study ID Numbers: GO27935
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas