NCT03676270

Brief Summary

Overview of response rate published in recent oncology phase I trials

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,915

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

January 7, 2021

Completed
Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

1.4 years

First QC Date

September 17, 2018

Results QC Date

December 8, 2020

Last Update Submit

January 5, 2021

Conditions

Cancer

Keywords

CancerPhase I trialsReview

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Phase IOTHER

Chemotherapy, ITK, Hormotherapy, Immunotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

unit of analysis = trial (analysis of aggregated data only, with the trial as the unit of analysis)

Trials based on the following eligibility criteria: * cancer phase 1 trials * published from January 1, 2014, through June 30, 2015

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Insitut Bergonié

Bordeaux, 33076, France

Location

Related 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. No abstract available.

    PMID: 29874526RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

Clinical Trials, Phase I as Topic

Intervention Hierarchy (Ancestors)

Clinical Trials as TopicClinical Studies as TopicEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Pr Antoine Italiano
Organization
Institut Bergonié
a.italiano@bordeaux.unicancer.fr
335 56333333

Study Officials

  • Antoine Italiano, MD-PhD

    Institut Bergonié

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 18, 2018

Study Start

January 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2018

Last Updated

January 7, 2021

Results First Posted

January 7, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)