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OpenTrials
Completed

NCT Number: NCT03676270

Trends in Modern Phase 1 Oncology Trials

Overview of response rate published in recent oncology phase I trials

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Insitut Bergonié

Bordeaux, 33076, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Trials based on the following eligibility criteria:

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

Treatment and study plan

Phase I

Other

Chemotherapy, ITK, Hormotherapy, Immunotherapy

Primary outcomes

  1. Response Rate

    Time frame: up to 6 months after treatment initiation

    Number of reported responses (complete [CR] and partial [PR]) divided by the number of reported assessable patients

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Acronym: Phase 1

Important dates

Study start
2014
Primary completion
2015
Study completion
2018
First posted
Sep 18, 2018
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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