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

NCT01314105 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-02-13

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-15
Primary Completion
2013-07-29
Completion
2016-04-04

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01314105 on ClinicalTrials.gov