A Study of DEDN6526A in Patients With Metastatic or Unresectable Melanoma

• Sponsor: Genentech, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01522664
• Collaborator: (none)
• Enrollment: 53
• Locations: 6
• Arm: 1
• Duration (Months): 39
• Patients Per Site: 8.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Malignant Melanoma	Drug: DEDN6526A	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single group	Drug: DEDN6526A; Multiple ascending doses

Outcome Measures

Primary Outcome Measures

1. Safety: Incidence of adverse events [assessed on an ongoing basis and up to 90 days following last dose of study treatment]

2. Maximum tolerated dose/dose-limiting toxicities [approximately one year after study start]

3. Determination of recommended Phase II dose [approximately 2 years]

Secondary Outcome Measures

1. 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]

2. Anti-therapeutic antibody (ATA) levels [Pre-dose Day 1 Cycles 1-4, and within 30 days post last dose]

3. Tumor response (tumor assessments according to RECIST criteria) [up to approximately 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Los Angeles	California	United States	90025
2		Sarasota	Florida	United States	34232
3		Detroit	Michigan	United States	48201
4		Nashville	Tennessee	United States	37203
5		Camperdown	New South Wales	Australia	2050
6		East Melbourne	Victoria	Australia	3002

Sponsors and Collaborators

• Genentech, Inc.

Investigators

• Study Director: Clinical Trials, Genentech, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT01522664
• Other Study ID Numbers: GO27935
• First Posted: Jan 31, 2012
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Melanoma

Study Results

No Results Posted as of Nov 2, 2016