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NCT03676270 Clinical Trial

Trends in Modern Phase 1 Oncology Trials

Cancer Clinical Trial

— Phase 1  

Official title:
Trends in Modern Phase 1 Oncology Trials

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03676270
Other study ID # IB-2018Phase I
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2014
Est. completion date June 2018

Study information
Verified date January 2021
Source Institut Bergonié
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Overview of response rate published in recent oncology phase I trials

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 information / eligibility
Status Completed
Enrollment 6915
Est. completion date June 2018
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Trials based on the following eligibility criteria: - cancer phase 1 trials - published from January 1, 2014, through June 30, 2015

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Phase I
Chemotherapy, ITK, Hormotherapy, Immunotherapy

Locations
Country Name City State
France Insitut Bergonié Bordeaux

Sponsors (1)
Lead Sponsor Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

References & Publications (1)

Chakiba C, Grellety T, Bellera C, Italiano A. Encouraging Trends in Modern Phase 1 Oncology Trials. N Engl J Med. 2018 Jun 7;378(23):2242-2243. doi: 10.1056/NEJMc1803837. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Response Rate Number of reported responses (complete [CR] and partial [PR]) divided by the number of reported assessable patients up to 6 months after treatment initiation
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