NCT01256268

Carboplatin/Taxol/Ridaforolimus in Endometrial, Ovarian and Solids

Phase 1A/B Study of Combination Carboplatin, Paclitaxel and Ridaforolimus in Patients With Solid, Endometrial, and Ovarian Cancers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to: * Test the safety of a new investigational drug called MK-8669 (ridaforolimus) * Determine the maximum tolerated dose of MK-8669 * Determine the effectiveness of the maximum tolerated dose of MK-8669

Detailed description

This is a phase 1A/1B study. Phase 1A is designed to determine the maximal tolerated dose (MTD) and toxicity of ridaforolimus in combination with paclitaxel and carboplatin in patients with advanced or recurrent solid tumors. The MTD determined in this study will be the recommended dose to study in the phase 1B or in future phase 2 trials.

Conditions

• Endometrial Cancer
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Ridaforolimus	Phase 1A: Ridaforolimus 20-40 mg will be administered daily for 5 days per week (days 2-5, days 8-12, days 15-19) in the first cycle of therapy and for further cycles on days 1-5, days 8-12, days 15-19 throughout the remainder of therapy. On the day of coadministration of ridaforolimus with paclitaxel 175mg/m\^2 IV and carboplatin AUC 5-6mg/ml/min on day 1 of each 3 week cycle, ridaforolimus will be dosed at the time of initiation of paclitaxel infusion. Phase 1B: as outlined in Treatment Arms.
DRUG	Paclitaxel	Phase 1A: Paclitaxel 175mg/m2 IV. Phase 1B: As outlined in Treatment Arms.
DRUG	carboplatin	Phase 1A: Carboplatin AUC 5-6mg/ml/min on day 1 of each 3 week cycle. Phase 1B: As outlined in Treatment Arms.

Timeline

• Start date: 2011-06-13
• Primary completion: 2016-02-03
• Completion: 2017-08-03
• First posted: 2010-12-08
• Last updated: 2017-08-30

Locations

1 site across 1 country: United States