NCT01329549

Dose Escalation Study of BIBF 1120 in Combination With Carboplatin and PLD in Relapsed Ovarian Cancer (OC)

An Open-label, Dose Escalation Phase I Study of the Safety and Tolerability of BIBF 1120 in Combination With Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Japanese Patients With a First, Second or Third Platinum-sensitive Relapse of Advanced Epithelial Ovarian Cancer, Fallopian Tube or Primary Peritoneal Cancer.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This phase I, open label dose escalation study will investigate the addition of BIBF 1120 to treatment with the combination of carboplatin and Pegylated Liposomal Doxorubicin (PLD) in patients with advanced, platinum sensitive relapsed ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer. Patients will be treated with BIBF 1120 together with carboplatin and PLD in up to 6-9 repeated 28 days treatment courses until disease progression is observed.

Conditions

• Ovarian Neoplasms

Interventions

Type	Name	Description
DRUG	BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min	BIBF 1120 twice daily along with standard therapy of PLD + CBDCA
DRUG	BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min	BIBF 1120 twice daily along with standard therapy of PLD + CBDCA
DRUG	BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min	BIBF 1120 twice daily along with standard therapy of PLD + CBDCA

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-04-06
• Last updated: 2014-11-27
• Results posted: 2014-11-27

Locations

3 sites across 1 country: Japan