A Rollover Study for Patients Who Received Tremelimumab in Other Protocols, to Allow the Patients Access to Tremelimumab Until This Agent Becomes Commercially Available or Development is Discontinued.
Phase 2
Completed
- Conditions
- Colorectal NeoplasmsMelanomaProstatic NeoplasmsRenal Cell CarcinomaNeoplasmsPatients Who Have/Have Had Melanoma and Other Tumors
- Registration Number
- NCT00378482
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 37
Inclusion Criteria
Inclusion Criteria:<br><br> - The subject must have already received tremelimumab in another protocol<br><br> - Females of childbearing potential must agree to practice a form of effective<br> contraception for 12 months following any dose of study drug. The definition of<br> effective contraception will be based on the judgement of the investigator.<br><br> - Subject must be willing and able to provide written informed consent and to comply<br> with scheduled visits and other trial procedures<br><br>Exclusion Criteria:<br><br> - None
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety Endpoints: Serious Adverse Events to Tremelimumab.;Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab.;Safety Endpoints: Hypersensitivity Reactions to Tremelimumab.;Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED);Efficacy Endpoints: Survival
- Secondary Outcome Measures
Name Time Method Disease Free Survival