NCT03056833

Ribociclib (Ribociclib (LEE-011)) With Platinum-based Chemotherapy in Recurrent Platinum Sensitive Ovarian Cancer

Phase I Trial of Ribociclib (Ribociclib (LEE-011)) With Platinum-based Chemotherapy in Recurrent Platinum Sensitive Ovarian Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Ronald Buckanovich · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Investigators hypothesize that concurrent ribociclib treatment and chemotherapy will enhance the response to platinum-based therapy and maintenance therapy will slow ovarian cancer tumor growth leading to prolongation in progression free survival.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Carcinoma

Interventions

Type	Name	Description
DRUG	ribociclib	Ribociclib (LEE-011) will be given on days 1-4, 8-11, and 15-18 of a 28 day cycle at 200, 400, or 600mg/day during the dose escalation phase. During the maintenance phase, ribociclib (LEE-011) will be given at 600mg/day, 3 weeks on, 1 week off until progression.
DRUG	Paclitaxel	During the escalation phase Paclitaxel will be given on days 1, 8, and 15 of a 28 day cycle.
DRUG	Carboplatin	During the escalation phase Carboplatin will be given on days 1, 8, and 15 of a 28 day cycle.

Timeline

• Start date: 2017-06-10
• Primary completion: 2020-06-01
• Completion: 2022-08-01
• First posted: 2017-02-17
• Last updated: 2022-09-07

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study