p53 Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Study of PLD With APR-246
NCT ID: NCT03268382
Last Updated: 2025-03-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2017-07-31
2019-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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APR-246 + PLD
APR-246
Intravenous infusion
Pegylated Liposomal Doxorubicin Hydrochloride (PLD)
Intravenous infusion
Interventions
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APR-246
Intravenous infusion
Pegylated Liposomal Doxorubicin Hydrochloride (PLD)
Intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* Disease Progression between 4 weeks - 6 months after the last platinum-based treatment was administered
* At least a single measurable lesion
* Adequate organ function prior to registration
* Toxicities from previous cancer therapies (excluding alopecia) must have recovered to grade 1 (defined by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 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 2
Exclusion Criteria
* 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 weeks 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. Palliative limited radiation therapy for pain reduction is allowed
18 Years
FEMALE
No
Sponsors
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Aprea Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Charlie Gourley, BSc, MB ChB, PhD, FRCP
Role: PRINCIPAL_INVESTIGATOR
Edinburgh Cancer Research Centre, The University of Edinburgh
Locations
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Medische oncologie, Universitair Ziekenhuis Gent
Ghent, , Belgium
Leuven University Hospitals
Leuven, , Belgium
Centre Hospitalier Universitaire de Liège
Liège, , Belgium
Institut Català d'Oncologia, Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
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 Royal Marsden NHS Foundation Trust
London, , United Kingdom
Imperial College London, Hammersmith Hospital Campus
London, , 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-486
Identifier Type: -
Identifier Source: org_study_id
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