A Study of DEDN6526A in Patients With Metastatic or Unresectable Melanoma
NCT ID: NCT01522664
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
53 participants
INTERVENTIONAL
2012-03-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single group
DEDN6526A
Multiple ascending doses
Interventions
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DEDN6526A
Multiple ascending doses
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Los Angeles, California, United States
Sarasota, Florida, United States
Detroit, Michigan, United States
Nashville, Tennessee, United States
Camperdown, New South Wales, Australia
East Melbourne, Victoria, Australia
Countries
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References
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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.
Other Identifiers
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GO27935
Identifier Type: -
Identifier Source: org_study_id