PiSARRO-R
Research type
Research Study
Full title
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
IRAS ID
226283
Contact name
Marie Moores
Contact email
Sponsor organisation
Aprea Therapeutics AB
Eudract number
2017-000265-67
Clinicaltrials.gov Identifier
124841 , IND
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This a study with developmental drug APR-246 given in combination with chemotherapy drug PLD. APR-246 has been developed by Aprea Therapeutics 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 in found to be deactivated. Early research has shown that APR-246 may be able to reactive p53 in tumour cells, which should make the tumour cells respond better to certain chemotherapy agents. APR-246 has been already given to patients in previous studies, showing that it is overall well tolerated.
The current study will investigate where APR-246 will be an effective and safe treatment option for patients with platinum-resistant High Grade Serous Ovarian Cancer (HGSOC). The study will be conducted with up to 25 patients in up to 10 hospitals in UK, Belgium and Spain. Drug distribution (pharmacokinetics) and tumour biopsies will also be evaluated in some patients.REC name
London - Westminster Research Ethics Committee
REC reference
17/LO/1040
Date of REC Opinion
1 Aug 2017
REC opinion
Favourable Opinion