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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 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. The trial reports 20 study locations across 11 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02098343
The ClinicalTrials.gov registry entry for NCT02098343 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 247 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aprea Therapeutics, which has 9 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
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