PiSARRO
Research type
Research Study
Full title
PiSARRO: 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
IRAS ID
137274
Contact name
John A Green
Contact email
Sponsor organisation
Aprea AB
Eudract number
2013-001472-38
Research summary
This is a study of the drug APR-246 given with the chemotherapy drugs carboplatin and PLD. APR-246 has been developed by Aprea AB, to specifically target a protein present in cells called p53. In many cases where tumours have become resistant to standard chemotherapy, the p53 protein is found to be deactivated. Early research has shown that APR-246 may be able to reactivate p53 in tumour cells, which should make the tumour cells respond better to certain chemotherapy agents.
APR-246 is a new, experimental drug and has already been given to 32 patients with different types of cancer in a previous study, which showed it was well tolerated overall.
The current study investigates whether APR-246 will be an effective and safe treatment option for patients with Recurrent High Grade Serous Ovarian Cancer (HGSOC). The study will be conducted in 2 phases; the first phase (Ib) will involve about 21 participants at 5 hospitals in the UK and Belgium and the main objective is to determine a suitable dose of APR-246 to use in conjunction with combination chemotherapy for the second phase. Phase II will be randomised in a 1:1 ratio of combination chemotherapy with or without APR-246. The main objective is a preliminary evaluation of efficacy in this patient population. Overall up to 180 patients may be enrolled in this study.
Drug distribution (pharmacokinetics) and tumour biopsies will also be evaluated in some patients.REC name
North West - Haydock Research Ethics Committee
REC reference
13/NW/0697
Date of REC Opinion
2 Dec 2013
REC opinion
Further Information Favourable Opinion