Status:
COMPLETED
p53 Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Study of PLD With APR-246
Lead Sponsor:
Aprea Therapeutics
Conditions:
High-grade Serous Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and PLD chemotherapy regimen in patients with platinum-resistant recurrent high grade serous ovarian...
Eligibility Criteria
Inclusion
- Confirmed High Grade Serous Ovarian Cancer, and positive nuclear immunohistochemical (IHC) staining for p53
- 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
- Prior exposure to cumulative doses of doxorubicin \>400 mg/m2 or epirubicin \>720 mg/m2
- 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
Key Trial Info
Start Date :
July 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03268382
Start Date
July 31 2017
End Date
July 10 2019
Last Update
March 17 2025
Active Locations (12)
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1
Medische oncologie, Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
2
Leuven University Hospitals
Leuven, Belgium, B-3000
3
Centre Hospitalier Universitaire de Liège
Liège, Belgium, B-4000
4
Institut Català d'Oncologia, Hospital Germans Trias i Pujol
Badalona, Spain, 08916