A Study of DEDN6526A in Patients With Metastatic or Unresectable Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01522664
First received: January 20, 2012
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

This multicenter, open-label study will assess the safety and pharmacokinetics o f DEDN6526A in patients with metastatic or unresectable melanoma. Cohorts of pat ients 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 to xicity, 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:

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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522664

Locations
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
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01522664     History of Changes
Other Study ID Numbers: GO27935
Study First Received: January 20, 2012
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014