A Study of DEDN6526A in Patients With Metastatic or Unresectable Melanoma

Malignant Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522664
• Other study ID #: GO27935
• Status: Completed
• Phase: Phase 1
• First received: January 20, 2012
• Last updated: November 1, 2016
• Start date: March 2012
• Est. completion date: June 2015

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Drug:
• DEDN6526A
Multiple ascending doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		assessed on an ongoing basis and up to 90 days following last dose of study treatment	Yes
Primary	Maximum tolerated dose/dose-limiting toxicities		approximately one year after study start	Yes
Primary	Determination of recommended Phase II dose		approximately 2 years	No
Secondary	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	No
Secondary	Anti-therapeutic antibody (ATA) levels		Pre-dose Day 1 Cycles 1-4, and within 30 days post last dose	No
Secondary	Tumor response (tumor assessments according to RECIST criteria)		up to approximately 1 year	No