Study Results
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View full resultsBasic Information
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COMPLETED
6915 participants
OBSERVATIONAL
2014-01-31
2018-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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OTHER
RETROSPECTIVE
Interventions
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Phase I
Chemotherapy, ITK, Hormotherapy, Immunotherapy
Eligibility Criteria
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Inclusion Criteria
* cancer phase 1 trials
* published from January 1, 2014, through June 30, 2015
18 Years
ALL
No
Sponsors
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Institut Bergonié
OTHER
Responsible Party
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Principal Investigators
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Antoine Italiano, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
Institut Bergonié
Locations
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Insitut Bergonié
Bordeaux, , France
Countries
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References
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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. No abstract available.
Other Identifiers
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IB-2018Phase I
Identifier Type: -
Identifier Source: org_study_id
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