Trial Outcomes & Findings for Trends in Modern Phase 1 Oncology Trials (NCT NCT03676270)

NCT ID: NCT03676270

Last Updated: 2021-01-07

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

6915 participants

Primary outcome timeframe

up to 6 months after treatment initiation

Results posted on

2021-01-07

Participant Flow

224 trials were analyzed which included 6915 participants

Unit of analysis: trials

Participant milestones

Participant milestones
Measure
Participants Included in Phase 1 Oncology Trials
Participants included in Phase 1 Oncology Trials, published from January 1, 2014, through June 30, 2015.
Overall Study
STARTED
6915 224
Overall Study
COMPLETED
6915 224
Overall Study
NOT COMPLETED
0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Trials
n=6915 Participants
Cancer Phase 1 trials
Age, Customized
trials with participant > 18 years old
6915 Participants
n=6915 Participants
Sex: Female, Male
Female
3458 Participants
n=6915 Participants
Sex: Female, Male
Male
3457 Participants
n=6915 Participants

PRIMARY outcome

Timeframe: up to 6 months after treatment initiation

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

Outcome measures

Outcome measures
Measure
Phase 1 Oncology Trials
n=6915 Participants
Phase 1 Oncology Trials, published from January 1, 2014, through June 30, 2015.
Response Rate
1371 Participants

Adverse Events

Participants Included in Phase 1 Oncology Trials

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pr Antoine Italiano

Institut BergoniƩ

Phone: 335 56333333

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place