CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 19 enrolled
Drug / intervention
BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min +2 moredrug
Likely dose
BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*minfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01314105
NCT01314105Phase 1Completed
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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

Boehringer Ingelheim·interventional·Posted Mar 14, 2011·Updated Feb 13, 2025

In Brief

A Phase 1 clinical trial evaluating BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min and BIBF 1120+ PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min for Ovarian Neoplasms and Peritoneal Neoplasms. Completed, enrolled 19 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Neoplasms, Peritoneal Neoplasms
CountriesSpain
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 14, 2011
Enrollment StartMar 15, 2011
Primary CompletionJul 29, 2013
Study CompletionApr 4, 2016
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 15.3 years ago

Interventions

BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*mindrug

BIBF1120 twice daily along with standard therapy of PLD + carboplatin

BIBF 1120+ PLD 30 mg/m2 + CBDCA AUC5 mg/mL*mindrug

BIBF1120 twice daily along with standard therapy of PLD + carboplatin

BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*mindrug

BIBF1120 twice daily along with standard therapy of PLD + carboplatin