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Clinical Trials/NCT00518895
NCT00518895CompletedPhase 3

A Multicenter, Randomized, Double-blind Study of Dacarbazine With or Without Genasense in Chemotherapy-naive Subjects With Advanced Melanoma and Low LDH (The AGENDA Trial)

Genta Incorporated76 sites in 7 countries300 target enrollmentStarted: July 2007Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
300
Locations
76
Primary Endpoint
Progression-free survival and overall survival

Study Overview

Brief Summary

This study is being performed to prospectively determine whether dacarbazine plus Genasense is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial of dacarbazine plus Genasense.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histologically confirmed diagnosis of melanoma
  • Progressive disease that is not surgically resectable, or metastatic Stage IV
  • Low-normal LDH, defined as ≤ 0.8 times the upper limit of normal
  • No prior chemotherapy
  • Measurable disease
  • ECOG performance status ≤ 1
  • At least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy
  • Prior immunotherapy allowed
  • Adequate organ function

Exclusion Criteria

  • Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense treatment
  • Primary ocular or mucosal melanoma
  • Bone-only metastatic disease
  • History or presence of brain metastasis or leptomeningeal disease
  • Significant medical disease other than cancer
  • Organ allograft

Arms & Interventions

A

Experimental

Dacarbazine with Genasense

Intervention: dacarbazine plus Genasense (Drug)

B

Active Comparator

Dacarbazine with placebo

Intervention: dacarbazine plus placebo (Drug)

Outcomes

Primary Outcomes

Progression-free survival and overall survival

Time Frame: Every 42 days from date of randomization during protocol therapy

Secondary Outcomes

  • Response rate, durable response rate, duration of response, safety(Response and progression every 42 days from date of randomization during protocol therapy)

Investigators

Sponsor
Genta Incorporated
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (76)

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