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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
NCT02098343 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02098343 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, Pennsylvania, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02098343?
The interventions under investigation include: APR-246 (DRUG), Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02098343?
This trial is sponsored by Aprea Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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