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NCT03314935 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
A Phase 1 study of Ovarian Cancer and Endometrial Cancer, sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 149
- Enrollment target
- 10
- Study locations
NCT03314935: Completed Phase 1 study of Ovarian Cancer and Endometrial Cancer, sponsored by Incyte Corporation.
NCT03314935 is a Phase 1 study of Ovarian Cancer and Endometrial Cancer that has completed, run by Incyte Corporation. The registered enrollment target is 149 participants, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (80% lower). The trial reports 10 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03314935, a Phase 1 study of Ovarian Cancer and Endometrial Cancer, has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 149 participants
- Enrollment target
- 10
- Study locations
Study Summary
The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.
Primary Outcome
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the st
Conditions Studied
Interventions
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Gemcitabine
- DRUG 5-Fluorouracil
- DRUG INCB001158
Study Locations (10)
Other
- Grand Hopital de Charleroi - Department of Medical Oncology - Brussels
- Institut Jules Bordet - Clinical Trials Conduct Unit - Brussels
- UCL Cancer Institute - London
- The Christie NHS Foundation Trust - Manchester
Alabama
- University of Alabama - Birmingham
- USA Mitchell Cancer Center - Mobile
Texas
- The University of Texas MD Anderson Cancer Center - Houston
- START San Antonio - San Antonio
California
- UC Davis - Comprehensive Cancer Centre - Sacramento
Georgia
- Northwest Georgia Oncology Centers - Marietta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2017-11-21 |
| Est. Completion | 2022-11-28 |
| Phase | Phase 1 |
What the finished NCT03314935 record still lists
NCT03314935 is an interventional study that assigns participants to a tested intervention. The registered 149 participants enrollment target is mid-sized for trials with a published cap, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (80% lower).
The record links to 6 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 5 interventions - of which Leucovorin is the first listed.
NCT03314935 lists 10 locations in 5 states (Other, Alabama, Texas).
Frequently Asked Questions
What is clinical trial NCT03314935 about?
NCT03314935 is a clinical study titled "A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors". The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.
What is the current status of trial NCT03314935?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 149 participants. The study started on 2017-11-21. Estimated completion is 2022-11-28.
What conditions does trial NCT03314935 study?
This clinical trial studies the following conditions: Ovarian Cancer, Endometrial Cancer, Solid Tumors, Colorectal Cancer (CRC), Biliary Tract Cancer (BTC).
What interventions are being tested in trial NCT03314935?
The interventions under investigation include: Leucovorin (DRUG), Oxaliplatin (DRUG), Gemcitabine (DRUG), 5-Fluorouracil (DRUG), INCB001158 (DRUG).
Who is sponsoring clinical trial NCT03314935?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03314935 being conducted?
This trial has 10 study locations across Alabama, California, Georgia, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03314935's enrollment target sits among peer trials
149 124th of 322 higher than 199 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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