Trends in Modern Phase 1 Oncology Trials

I

Institut Bergonié

Status

Completed

Conditions

Cancer

Treatments

Other: Phase I

Study type

Observational

Funder types

Other

Identifiers

NCT03676270
IB-2018Phase I

Details and patient eligibility

About

Overview of response rate published in recent oncology phase I trials

Full 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.

Enrollment

6,915 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Trials based on the following eligibility criteria:

  • cancer phase 1 trials
  • published from January 1, 2014, through June 30, 2015

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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