Trends in Modern Phase 1 Oncology Trials
- Conditions
- Cancer
- Registration Number
- NCT03676270
- Lead Sponsor
- Institut Bergonié
- Brief Summary
Overview of response rate published in recent oncology phase I trials
- Detailed Description
Critics have raised a fundamental ethical challenge about phase 1 cancer research. They point to an expected paucity of benefits, since approximately 5% of patients in phase 1 trials are reported to have tumor shrinkage.
Objective was to conduct a search of the literature using PubMed to identify articles about phase 1 trials that were published from January 1, 2014, through June 30, 2015. The primary end point was the response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Clinically relevant trials' characteristics were investigated as candidate factors associated with the RR: Funding source (Academic / Industrial), First-in man trial (Yes / No), Expansion cohort (Yes / No), Number of targeted organs (Single / Multiple), Therapy (Single / Combination), Treatment (MAB-Immuno / ITK / Chimioth-HT-other), Biological eligibility criterion (Yes / No), as well as the number of assessable patients, which for ease of clinical interpretation was transformed into a qualitative variable (0-25 / 26 - 50 / 51+).
The RR was described according to the individual trials' characteristics. Associations with trials's characteristics were investigated using statistical modeling.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6915
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response Rate up to 6 months after treatment initiation Number of reported responses (complete \[CR\] and partial \[PR\]) divided by the number of reported assessable patients
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Insitut Bergonié
🇫🇷Bordeaux, France