NCT02312804

Ph Ib/BGJ398/Cervix and Other Solid Tumors

A Phase Ib Study Evaluating BGJ398 in Combination With Chemotherapeutic Regimen in Patients With Stage IV, Recurrent or Persistent Carcinoma of The Cervix and Other Solid Tumors

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted using 3+3 design and includes, a dose escalation part to define the MTDfRP2D for the combination of BGJ398 and carboplatin/paclitaxel, and a dose expansion part to treat another 12 patients (only cervix cancer) to further evaluate safety of this combination. Safety, tolerability and MTD will be determined in the dose escalation part of the study. The dose expansion will additionally investigate preliminary anti-tumor efficacy in cervical cancer. The dosing cycle is 21 days.

Conditions

• Cancer of Cervix
• Tumors

Interventions

Type	Name	Description
DRUG	BGJ398	BGJ398 will be administered orally once daily on each day of the 21 day cycle.
DRUG	Carboplatin	Carboplatin will be administered in combination with paclitaxel intravenously on the first day of each 21-day cycle.
DRUG	Paclitaxel	Paclitaxel will be administered in combination with carboplatin intravenously on the first day of each 21-day cycle.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-12-09
• Last updated: 2015-02-16