AGENDA: Randomised, double-blind trial of dacarbazine with or without Genasense® (oblimersen, G3139) in advanced melanoma
- Conditions
- CancerMalignant melanoma of skinMelanoma
- Registration Number
- ISRCTN34237167
- Lead Sponsor
- Genta Incorporated (USA)
- Brief Summary
2007 Abstract: Bedikian AY, Agarwala SS, Gilles E, Itri L, Kay R, Garbe C. The AGENDA Study: A randomized, double-blind study of Genasense plus dacarbazine (DTIC) in chemotherapy-naïve subjects with advanced melanoma and low LDH. Pigment Cell Res. 2007;20:538 (Abstract T-26) 2006 results in: https://www.ncbi.nlm.nih.gov/pubmed/16966688 (added 14/02/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 300
1. At least 18 years of age, both males and females
2. Histologically confirmed diagnosis of melanoma
3. Progressive disease that is not surgically resectable, or metastatic Stage IV disease
4. Low LDH (defined as LDH less than or equal to 0.8 x ULN)
5. Chemotherapy naïve
6. Measurable disease
7. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
8. 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
9. Adequate organ function
1. Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense® treatment
2. Primary ocular or mucosal melanoma
3. Bone-only metastatic disease
4. History or presence of brain metastasis or leptomeningeal disease
5. Significant medical disease other than cancer
6. Organ allograft
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival and overall survival
- Secondary Outcome Measures
Name Time Method <br> 1. Response rate<br> 2. Durable response rate<br> 3. Duration of response<br> 4. Safety<br><br> Follow-up every 2 months for up to 24 months from date of randomisation.<br>