Trials / Completed
CompletedNCT03268382
p53 Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Study of PLD With APR-246
PiSARRO-R: p53 Suppressor Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Phase II Study of Systemic Pegylated Liposomal Doxorubicin Chemotherapy With APR-246
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Aprea Therapeutics · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | APR-246 | Intravenous infusion |
| DRUG | Pegylated Liposomal Doxorubicin Hydrochloride (PLD) | Intravenous infusion |
Timeline
- Start date
- 2017-07-31
- Primary completion
- 2019-07-10
- Completion
- 2019-07-10
- First posted
- 2017-08-31
- Last updated
- 2025-03-17
- Results posted
- 2022-07-21
Locations
12 sites across 3 countries: Belgium, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03268382. Inclusion in this directory is not an endorsement.