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: July 7, 2014
Last verified: July 2014

January 20, 2012
July 7, 2014
March 2012
March 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01522664 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of DEDN6526A in Patients With Metastatic or Unresectable Melanoma
A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DEDN6526A in Patients With Metastatic or Unresectable Melanoma

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).

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
Drug: DEDN6526A
Multiple ascending doses
Experimental: Single group
Intervention: Drug: DEDN6526A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
53
March 2015
March 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT01522664
GO27935
Not Provided
Genentech
Genentech
Not Provided
Study Director: Clinical Trials Genentech
Genentech
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP