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

Completed · Phase 1/Phase 2

Conditions studied: Platinum Sensitive Recurrent High-grade Serous Ovarian Cancer With Mutated p53

In brief

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.

Key facts

Study ID

NCT02098343

Run by

Aprea Therapeutics

People needed

247

Starts

2014-03-01

Expected to finish

2019-04-01

Last updated by the study team

2025-03-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed High Grade Serous Ovarian Cancer, and positive nuclear immunohistochemical (IHC) staining for p53
• Disease Progression between 6-24 months after a first or second platinum based regimen
• At least a single measurable lesion. Phase II patients only
• Adequate organ function prior to registration
• Toxicities from previous cancer therapies must have recovered to grade 1 (defined by Common Terminology Criteria for Adverse Events [CTCAE] 4.0) Chronic stable grade 2 peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis
• ECOG performance status of 0 to 1

You may not qualify if…

• Prior exposure to cumulative doses of doxorubicin >400 mg/m2 or epirubicin >720 mg/m2
• History of allergic reactions to carboplatin, platinum containing compounds or mannitol and/or hypersensitivity to PLD or to any of the excipients
• Unable to undergo imaging by either CT scan or MRI
• Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications
• Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ)
• Is taking concurrent (or within 4 week prior to registration) chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation). Supportive care measures are allowed

Where it is running

• University of Chicago — Chicago, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Oregon Health & Science University — Portland, Oregon, United States
• The University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• UPMC Hillman Cancer Center, Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Parkland, UT Southwestern Medical Center — Dallas, Texas, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Massey Cancer Center, Virginia Commonwealth University — Richmond, Virginia, United States
• Swedish Cancer Institute — Seattle, Washington, United States
• Antwerp University Hospital — Antwerp, Belgium
• Institut Jules Bordet — Brussels, Belgium
• Cliniques Universitaires Saint Luc — Brussels, Belgium
• Medische oncologie, Universitair Ziekenhuis Gent — Ghent, Belgium
• Leuven University Hospitals — Leuven, Belgium
• Centre Léon Bérard — Lyon, France
• Centre Hospitalier Lyon Sud — Lyon, France
• Centre Catherine de Sienne — Nantes, France
• Institut Curie — Paris, France
• Hôpital des Diaconesses (Site Reuilly) — Paris, France
• UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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