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 cancer (HGSOC) with mutated TP53. In addition, the study aims to assess the safety profile of the combined APR-246 and PLD chemotherapy regimen, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll at least 25 evaluable patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Intravenous infusion
Intravenous infusion
Medische oncologie, Universitair Ziekenhuis Gent
Ghent, Belgium
Leuven University Hospitals
Leuven, Belgium
Centre Hospitalier Universitaire de Liège
Liège, Belgium
Overall Response Rate (ORR)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 18 months
Treatment-emergent Adverse Events With Combined APR-246 and PLD Regimen
Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. AEs were graded according to NCI CTCAE (Version 4.0). Patients with multiple TEAEs were only counted once within a summary category: SOC, PT, maximum grade, or relationship to treatment. Patients with events in more than one category were counted once within each category.
Time frame: Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
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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
...and 2 more locations