- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03676270
Trends in Modern Phase 1 Oncology Trials (Phase 1)
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bordeaux, France, 33076
- Insitut Bergonié
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Trials based on the following eligibility criteria:
- cancer phase 1 trials
- published from January 1, 2014, through June 30, 2015
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate
Time Frame: up to 6 months after treatment initiation
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Number of reported responses (complete [CR] and partial [PR]) divided by the number of reported assessable patients
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up to 6 months after treatment initiation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Antoine Italiano, MD-PhD, Institut Bergonié
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IB-2018Phase I
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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