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NCT02098343 · ClinicalTrials.gov registry record · Phase 1
p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246
A Phase 1 study of Platinum Sensitive Recurrent High-grade Serous Ovarian Cancer With Mutated p53, sponsored by Aprea Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 247
- Enrollment target
- 20
- Study locations
NCT02098343: Completed Phase 1 study of Platinum Sensitive Recurrent High-grade Serous Ovarian Cancer With Mutated p53, sponsored by Aprea Therapeutics.
NCT02098343 is a Phase 1 study of Platinum Sensitive Recurrent High-grade Serous Ovarian Cancer With Mutated p53 that has completed, run by Aprea Therapeutics. The registered enrollment target is 247 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (312% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02098343, a Phase 1 study of Platinum Sensitive Recurrent High-grade Serous Ovarian Cancer With Mutated p53, has completed, sponsored by Aprea Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 247 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and carboplatin/PLD chemotherapy regimen, compared with carboplatin/PLD chemotherapy regimen alone, in patients with platinum sensitive recurrent high grade serous ovarian cancer (HGSOC) with mutated p53. In addition, the study aims to assess the safety profile of the combined APR-246 and carboplatin/PLD chemotherapy regimen compared with carboplatin/PLD chemotherapy regimen alone, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll up to a maximum of 400 patients.
Primary Outcome
DLT: Hematological and non-hematological toxicities according to grade/days stated in the protocol.
Interventions
- DRUG APR-246
- DRUG Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD)
Study Locations (20)
Other
- Antwerp University Hospital - Antwerp
- Institut Jules Bordet - Brussels
- Cliniques Universitaires Saint Luc - Brussels
- Medische oncologie, Universitair Ziekenhuis Gent - Ghent
- Leuven University Hospitals - Leuven
Pennsylvania
- The University of Pennsylvania - Philadelphia
- Fox Chase Cancer Center - Philadelphia
- UPMC Hillman Cancer Center, Magee-Womens Hospital - Pittsburgh
Texas
- Parkland, UT Southwestern Medical Center - Dallas
- University of Texas Southwestern Medical Center - Dallas
- The University of Texas MD Anderson Cancer Center - Houston
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
California
- UCLA - Los Angeles
Illinois
- University of Chicago - Chicago
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 247 participants |
| Start Date | 2014-03 |
| Est. Completion | 2019-04 |
| Phase | Phase 1 |
What the finished NCT02098343 record still lists
NCT02098343 is an interventional study that assigns participants to a tested intervention. The registered 247 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (312% higher).
The record links to 1 condition, with Platinum Sensitive Recurrent High-grade Serous Ovarian Cancer With Mutated p53 appearing as the primary indexed condition, and to 2 interventions - of which APR-246 is the first listed.
NCT02098343 names 20 study sites across 11 states, led by Other, Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT02098343 about?
NCT02098343 is a clinical study titled "p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246". The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and carboplatin/PLD chemotherapy regimen, compared with carboplatin/PLD chemotherapy regimen alone, in patients with platinum sensitive recurrent high grade serous ovarian cancer (HGSOC) with mutated ...
What is the current status of trial NCT02098343?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 247 participants. The study started on 2014-03. Estimated completion is 2019-04.
What conditions does trial NCT02098343 study?
This clinical trial studies the following conditions: Platinum Sensitive Recurrent High-grade Serous Ovarian Cancer With Mutated p53.
What interventions are being tested in trial NCT02098343?
The interventions under investigation include: APR-246 (DRUG), Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD) (DRUG).
Who is sponsoring clinical trial NCT02098343?
This trial is sponsored by Aprea Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02098343 being conducted?
This trial has 20 study locations across California, Illinois, Massachusetts, Michigan, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02098343's enrollment target sits among peer trials
247 187th of 2000 higher than 1,813 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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