Safety and Efficacy of Quisinostat, a Histone Deacetylase Inhibitor, in Combination With Chemotherapy
NCT02948075 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2018-06-27
Summary
This is a multicenter, open-label study of safety and efficacy of Quisinostat in combination with Paclitaxel + Carboplatin chemotherapy in patients with metastatic or locally advanced epithelial ovarian cancer, primarily peritoneal or fallopian tube carcinoma, resistant to first line platinum and Paclitaxel based chemotherapy.
The study will be carried out in 5-8 Russian and Belarusian sites. A maximum of 32 patients with metastatic or locally advanced epithelial ovarian cancer, primarily peritoneal or fallopian tube carcinoma, resistant to first line platinum and Paclitaxel based chemotherapy, will be enrolled in the study.
Conditions
Interventions
- DRUG
-
Quisinostat
- DRUG
- DRUG
Sponsors & Collaborators
-
Janssen Pharmaceutica N.V., Belgium
collaborator INDUSTRY -
NewVac LLC
lead INDUSTRY
Principal Investigators
-
Sergei A. Tjulandin, Prof. · Russian Oncological Research Center n.a. N.N. Blokhin RAMS
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-30
- Primary Completion
- 2016-12-31
- Completion
- 2017-06-16
Countries
- Russia
Study Locations
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