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Doxorubicin + BIBF 1120 in Patients for Ovarian Cancer

NCT01485874 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-02-15

No results posted yet for this study

Summary

The purpose of this trial is to determine whether BIBF 1120 can be safely combined with pegylated liposomal doxorubicin (phase I), and to determine the clinical activity of the combination in patients with platinum-resistant ovarian cancer (phase II).

Conditions

Interventions

DRUG

Doxil (Pegylated Liposomal Doxorubicin)

Phases I and II: 40 mg/m2 IV over 60 min (+/- 15 min) on day 1 of 28-day cycle

DRUG

BIBF 1120

Phase I: Escalating cohorts days -2 through +2, orally 100mg bid, 150mg bid, 200mg bid Phase II: MTD orally, bid, day 2 of 28-day cycle

Sponsors & Collaborators

Principal Investigators

  • Daniela Matei, M.D. · Hoosier Cancer Research Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
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 NCT01485874 on ClinicalTrials.gov