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
| 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
| 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 initiationNumber of reported responses (complete \[CR\] and partial \[PR\]) divided by the number of reported assessable patients
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place