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NCT Number: NCT01522664

A Study of DEDN6526A in Patients With Metastatic or Unresectable Melanoma

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).

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Key information

Conditions

Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

DEDN6526A

Drug

Multiple ascending doses

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: assessed on an ongoing basis and up to 90 days following last dose of study treatment

  2. Maximum tolerated dose/dose-limiting toxicities

    Time frame: approximately one year after study start

  3. Determination of recommended Phase II dose

    Time frame: approximately 2 years

Secondary outcomes

  1. 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

  2. Anti-therapeutic antibody (ATA) levels

    Time frame: Pre-dose Day 1 Cycles 1-4, and within 30 days post last dose

  3. Tumor response (tumor assessments according to RECIST criteria)

    Time frame: up to approximately 1 year

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DEDN6526A in Patients With Metastatic or Unresectable Melanoma

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 31, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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