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

NCT01329549 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2014-11-27

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. 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

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

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Japan

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Entities

Companies

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 NCT01329549 on ClinicalTrials.gov