Ovarian Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

247

Study ID:

NCT02098343

Recruitment Status:

Completed

Sponsor:

Aprea Therapeutics

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There are 54 Locations for this study

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UCLA
Los Angeles California, 90095, United States
University of Chicago
Chicago Illinois, 60637, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
The University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
UPMC Hillman Cancer Center, Magee-Womens Hospital
Pittsburgh Pennsylvania, 15213, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Parkland, UT Southwestern Medical Center
Dallas Texas, 75390, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Massey Cancer Center, Virginia Commonwealth University
Richmond Virginia, 23298, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Antwerp University Hospital
Antwerpen , 2650, Belgium
Institut Jules Bordet
Brussels , 1000, Belgium
Cliniques Universitaires Saint Luc
Brussels , B-120, Belgium
Medische oncologie, Universitair Ziekenhuis Gent
Gent , 9000, Belgium
Leuven University Hospitals
Leuven , B-300, Belgium
Centre Léon Bérard
Lyon , 69373, France
Centre Hospitalier Lyon Sud
Lyon , 69495, France
Centre Catherine de Sienne
Nantes , 44202, France
Institut Curie
Paris , 75005, France
Hôpital des Diaconesses (Site Reuilly)
Paris , 75012, France
Centre Paul Strass
Strasbourg , 67065, France
Institut Gustave Roussy
Villejuif , 94805, France
Praxisklinik, Krebsheilkunde für Frauen
Berlin , 10367, Germany
Charité Campus Virchow-Klinikum
Berlin , 13353, Germany
Universitätsklinikum Carl Gustav Carus
Dresden , 01307, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg , 20246, Germany
Universitätsfrauenklinik Ulm
Ulm , 89075, Germany
Academisch Medisch Centrum
Amsterdam , 1105 , Netherlands
Universitair Medisch Centrum Groningen
Groningen , 9700 , Netherlands
Leids Universitair Medisch Centrum
Leiden , 2300 , Netherlands
Academisch Ziekenhuis Maastricht
Maastricht , 6229 , Netherlands
Institut Català d'Oncologia, Hospital Germans Trias i Pujol
Badalona , 08916, Spain
Hospital Vall d'Hebron
Barcelona , 08035, Spain
Hospital Universitario Reina Sofia
Córdoba , 14004, Spain
Centro Oncologico MD Anderson
Madrid , 28033, Spain
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid , 28040, Spain
Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain
Hospital Universitario Virgen de la Victoria
Málaga , 29010, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain
Hospital Universitario Araba
Vitoria-Gasteiz , 01009, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragosa , 50009, Spain
Karolinska University Hospital
Stockholm , SE-17, Sweden
Bristol Haematology & Oncology Centre, University Hospitals Bristol
Bristol , BS2 8, United Kingdom
Cambridge Cancer Trials Centre, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
Cambridge , CB2 0, United Kingdom
Edinburgh Cancer Research Centre, The University of Edinburgh
Edinburgh , EH4 2, United Kingdom
The Clatterbridge Cancer Center NHS Foundation Trust
Liverpool , CH63 , United Kingdom
The Royal Marsden NHS Foundation Trust
London , SM2 5, United Kingdom
Imperial College London, Hammersmith Hospital Campus
London , W12 0, United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

247

Study ID:

NCT02098343

Recruitment Status:

Completed

Sponsor:


Aprea Therapeutics

How clear is this clinincal trial information?

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