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
NCT ID: NCT02098343
Last Updated: 2025-03-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
247 participants
INTERVENTIONAL
2014-03-31
2019-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase Ib. APR-246 (35mg/kg) + Carboplatin/PLD.
Dose escalation of APR-246.
APR-246
Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD)
Intravenous infusion.
Phase II: Arm A. APR-246 + Carboplatin/PLD.
Experimental
APR-246
Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD)
Intravenous infusion.
Phase II: Arm B. Carboplatin/PLD.
Active Comparator
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD)
Intravenous infusion.
Phase Ib. APR-246 (50mg/kg) + Carboplatin/PLD.
Dose escalation of APR-246.
APR-246
Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD)
Intravenous infusion.
Phase Ib. APR-246 (67.5mg/kg) + Carboplatin/PLD.
Dose escalation of APR-246.
APR-246
Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD)
Intravenous infusion.
Interventions
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APR-246
Intravenous infusion.
Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD)
Intravenous infusion.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Aprea Therapeutics
INDUSTRY
Responsible Party
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Locations
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UCLA
Los Angeles, California, United States
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
Centre Paul Strass
Strasbourg, , France
Institut Gustave Roussy
Villejuif, , France
Praxisklinik, Krebsheilkunde für Frauen
Berlin, , Germany
Charité Campus Virchow-Klinikum
Berlin, , Germany
Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitätsfrauenklinik Ulm
Ulm, , Germany
Academisch Medisch Centrum
Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Leids Universitair Medisch Centrum
Leiden, , Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
Institut Català d'Oncologia, Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Centro Oncologico MD Anderson
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Universitario Araba
Vitoria-Gasteiz, , Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, , Spain
Karolinska University Hospital
Stockholm, , Sweden
Bristol Haematology & Oncology Centre, University Hospitals Bristol
Bristol, , United Kingdom
Cambridge Cancer Trials Centre, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
Cambridge, , United Kingdom
Edinburgh Cancer Research Centre, The University of Edinburgh
Edinburgh, , United Kingdom
The Clatterbridge Cancer Center NHS Foundation Trust
Liverpool, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
Imperial College London, Hammersmith Hospital Campus
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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References
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Lehmann S, Bykov VJ, Ali D, Andren O, Cherif H, Tidefelt U, Uggla B, Yachnin J, Juliusson G, Moshfegh A, Paul C, Wiman KG, Andersson PO. Targeting p53 in vivo: a first-in-human study with p53-targeting compound APR-246 in refractory hematologic malignancies and prostate cancer. J Clin Oncol. 2012 Oct 10;30(29):3633-9. doi: 10.1200/JCO.2011.40.7783. Epub 2012 Sep 10.
Deneberg S, Cherif H, Lazarevic V, Andersson PO, von Euler M, Juliusson G, Lehmann S. An open-label phase I dose-finding study of APR-246 in hematological malignancies. Blood Cancer J. 2016 Jul 15;6(7):e447. doi: 10.1038/bcj.2016.60. No abstract available.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Aprea Therapeutics AB's website (Sponsor)
Other Identifiers
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APR-407
Identifier Type: -
Identifier Source: org_study_id
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