NCT02948075

Safety and Efficacy of Quisinostat, a Histone Deacetylase Inhibitor, in Combination With Chemotherapy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: NewVac LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will be consisted of screening period of 3 weeks before the beginning of Quisinostat administration, followed by the Investigational product treatment period of approximately 18 weeks (up to 6 cycles and 21 days for each cycle), a safety follow-up of 4 weeks after the last administration of the study therapy and post-treatment follow-up aimed at determination of progression-free survival, time to disease progression and overall survival rate in the study population. An interim analysis will be performed after 10 patients are evaluated for efficacy. If 1 or less from 10 patients have an objective response (OR), the study will be stopped early for futility. After screening and confirmation of inclusion/exclusion criteria, patients will be asked to come to the site to start taking Quisinostat. All patients will receive Quisinostat in the dose of 12 mg on Day 1, 3, 5, 7, 9 and 11 of each treatment cycle. Administration of Paclitaxel and Carboplatin will be performed on Day 7 of each cycle. The cycles will be repeated once every 3 weeks (21 days). In case of severe carboplatin hypersensitivity reaction, it is permitted to switch to Cisplatin (75mg/m2) as alternative to Carboplatin in the subsequent cycles. Patients will receive up to 6 cycles of study therapy and then patients will continue to be followed-up for ORR, PFS, TTP, OS assessment in the study population. The Post-treatment follow up will include: * End of treatment visit will take place in case of treatment's completion within 6 cycles of study therapy. * Early discontinuation visit will take place in case of the early study termination (before completion of 6 cycles) . The patients will be asked to make an Early discontinuation visit not later than in 4 weeks after administration of the last Investigational product dose. After End of treatment or Early Discontinuation visit the patient will continue to be followed- for up to 1 year from the start of study treatment or until ICRR-determined progression (or death) (whichever is earlier). This will include tumor assessments every 6 weeks (±7 days). Following disease progression, the Investigator will contact the patients or their relatives not less than once in 3 months in order to collect information concerning the patient's survival status and, cause of death. This will occur up to 1 year after initial start of treatment on this protocol.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Quisinostat
DRUG	Paclitaxel
DRUG	Carboplatin

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-12-01
• Completion: 2017-06-16
• First posted: 2016-10-28
• Last updated: 2018-06-27

Locations

6 sites across 1 country: Russia