NCT03676270

Trends in Modern Phase 1 Oncology Trials

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6,915 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
OTHER	Phase I	Chemotherapy, ITK, Hormotherapy, Immunotherapy

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-06-01
• Completion: 2018-06-01
• First posted: 2018-09-18
• Last updated: 2021-01-07
• Results posted: 2021-01-07

Locations

1 site across 1 country: France