CINOVA
Research type
Research Study
Full title
A Phase IIa Exploratory 2-stage Design Study of CriPec® docetaxel Monotherapy in Subjects with Platinum Resistant Ovarian Cancer.
IRAS ID
251111
Contact name
Rob Hanssen
Contact email
Sponsor organisation
Cristal Therapeutics
Eudract number
2018-002117-36
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
An efficacy and safety study of CriPec® docetaxel in patients with ovarian cancer
CriPec® docetaxel is a new therapy for advanced epithelial ovarian cancer. It is given as treatment when the tumour is found to be resistant or has developed resistance to the standard platinum-based therapy. There is no other standard therapy available for women with this type of cancer.
CriPec® docetaxel consists of the docetaxel encased in a very small CriPec® particle. Docetaxel is a medicine against cancer that is already approved by the authorities and that is commonly used alone or in combination with other medicines for many tumours such as ovarian, breast, lung and stomach. Laboratory and animal tests have shown that the CriPec® particle helps to deliver docetaxel more precisely to the tumour and will probably cause less side effects than docetaxel alone. CriPec® docetaxel has not yet been authorized in Europe by the authorities; this study investigates the therapy with CriPec® docetaxel in order to obtain this authorization and the license.
Laboratory and animal tests showed that CriPec® docetaxel is safe to use. Hereafter, CriPec® docetaxel was administered to 32 patients with different tumours to assess its safety and to determine at which dose it should be administered in humans. It was decided that 60 mg/m2 is a safe dose of CriPec® docetaxel when combined with corticosteroid (anti-inflammatory) premedication. This study will test the safety and efficacy of treatment with CriPec® docetaxel (at a dose of 60 mg/m2 intravenously, with corticosteroid premedication, once every three weeks) in patients with platinum-resistant ovarian cancer.
REC name
London - Central Research Ethics Committee
REC reference
19/LO/0051
Date of REC Opinion
5 Mar 2019
REC opinion
Further Information Favourable Opinion