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
1 other identifier
interventional
53
2 countries
6
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2012
Typical duration for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2012
CompletedFirst Posted
Study publicly available on registry
January 31, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedNovember 2, 2016
November 1, 2016
3.3 years
January 20, 2012
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Safety: Incidence of adverse events
assessed on an ongoing basis and up to 90 days following last dose of study treatment
Maximum tolerated dose/dose-limiting toxicities
approximately one year after study start
Determination of recommended Phase II dose
approximately 2 years
Secondary Outcomes (3)
Pharmacokinetics: Area under the concentration-time curve
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
Anti-therapeutic antibody (ATA) levels
Pre-dose Day 1 Cycles 1-4, and within 30 days post last dose
Tumor response (tumor assessments according to RECIST criteria)
up to approximately 1 year
Study Arms (1)
Single group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (6)
Unknown Facility
Los Angeles, California, 90025, United States
Unknown Facility
Sarasota, Florida, 34232, United States
Unknown Facility
Detroit, Michigan, 48201, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Camperdown, New South Wales, 2050, Australia
Unknown Facility
East Melbourne, Victoria, 3002, Australia
Related Publications (1)
Sandhu S, McNeil CM, LoRusso P, Patel MR, Kabbarah O, Li C, Sanabria S, Flanagan WM, Yeh RF, Brunstein F, Nazzal D, Hicks R, Lemahieu V, Meng R, Hamid O, Infante JR. Phase I study of the anti-endothelin B receptor antibody-drug conjugate DEDN6526A in patients with metastatic or unresectable cutaneous, mucosal, or uveal melanoma. Invest New Drugs. 2020 Jun;38(3):844-854. doi: 10.1007/s10637-019-00832-1. Epub 2019 Aug 5.
PMID: 31385109DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2012
First Posted
January 31, 2012
Study Start
March 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
November 2, 2016
Record last verified: 2016-11