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
Study Sites (76)
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