A study of DEDN6526A in patients with metastatic or unresectable melanoma (clinicaltrials.gov) - Mar 14, 2012 - P1 , N=50; Not yet recruiting -> Recruiting; Start date: Feb 2012 -> Mar 2012; Completion date: Sep 2015 -> Oct 2015
Completion date • Enrollment open • Start date • Melanoma
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This study is currently recruiting participants.
Verified March 2012 by Genentech
First Received on January 20, 2012. Last Updated on March 14, 2012 History of Changes
Sponsor: Genentech
Information provided by (Responsible Party): Genentech
ClinicalTrials.gov Identifier: NCT01522664
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
Malignant Melanoma
Intervention
Drug: DEDN6526A
Phase
Phase I
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: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
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