NCT01314105

BIBF 1120 + Carboplatin/Pegylated Liposomal Doxorubicin (PLD) in Patients With Advanced Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer

Phase I Dose Escalation Trial to Determine the Maximum Tolerated Dose of BIBF 1120 in Combination With Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Patients With a First, Second or Third Platinum Sensitive Relapse of Advanced Epithelial Ovarian Cancer, Fallopian Tube or Primary Peritoneal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Female
• Age: 18 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.

Conditions

• Ovarian Neoplasms
• Peritoneal Neoplasms

Interventions

Type	Name	Description
DRUG	BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min	BIBF1120 twice daily along with standard therapy of PLD + carboplatin
DRUG	BIBF 1120+ PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min	BIBF1120 twice daily along with standard therapy of PLD + carboplatin
DRUG	BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min	BIBF1120 twice daily along with standard therapy of PLD + carboplatin

Timeline

• Start date: 2011-03-15
• Primary completion: 2013-07-29
• Completion: 2016-04-04
• First posted: 2011-03-14
• Last updated: 2025-02-13
• Results posted: 2014-11-20

Locations

3 sites across 1 country: Spain