A Study of DEDN6526A in Patients With Metastatic or Unresectable Melanoma - Full Text View

Purpose

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	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:

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

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 ]

Estimated Enrollment:	50
Study Start Date:	March 2012
Estimated Study Completion Date:	May 2015
Estimated Primary Completion Date:	May 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

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

Contacts

Contact: Please reference Study ID Number: GO27935 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Locations

United States, California
	Recruiting
Los Angeles, California, United States, 90025
United States, Tennessee
	Recruiting
Nashville, Tennessee, United States, 37203
Australia
	Not yet recruiting
Camperdown, Australia, 2050
	Recruiting
East Melbourne, 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:	January 23, 2013
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 May 16, 2013