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A Study of DEDN6526A in Patients With Metastatic or Unresectable Melanoma

Primary Purpose

Malignant Melanoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
DEDN6526A
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single group

Arm Description

Outcomes

Primary Outcome Measures

Safety: Incidence of adverse events
Maximum tolerated dose/dose-limiting toxicities
Determination of recommended Phase II dose

Secondary Outcome Measures

Pharmacokinetics: Area under the concentration-time curve
Anti-therapeutic antibody (ATA) levels
Tumor response (tumor assessments according to RECIST criteria)

Full Information

First Posted
January 20, 2012
Last Updated
November 1, 2016
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01522664
Brief Title
A Study of DEDN6526A in Patients With Metastatic or Unresectable Melanoma
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 Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DEDN6526A
Intervention Description
Multiple ascending doses
Primary Outcome Measure Information:
Title
Safety: Incidence of adverse events
Time Frame
assessed on an ongoing basis and up to 90 days following last dose of study treatment
Title
Maximum tolerated dose/dose-limiting toxicities
Time Frame
approximately one year after study start
Title
Determination of recommended Phase II dose
Time Frame
approximately 2 years
Secondary Outcome Measure Information:
Title
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
Title
Anti-therapeutic antibody (ATA) levels
Time Frame
Pre-dose Day 1 Cycles 1-4, and within 30 days post last dose
Title
Tumor response (tumor assessments according to RECIST criteria)
Time Frame
up to approximately 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
31385109
Citation
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.
Results Reference
derived

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A Study of DEDN6526A in Patients With Metastatic or Unresectable Melanoma

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