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

NCT ID: NCT01329549

Last Updated: 2014-11-27

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BIBF 1120 (low) + Carboplatin + PLD

BIBF 1120 (low dose) + carboplatin (AUC5 mg/mL\*min) + PLD (30 mg/m2)

Group Type EXPERIMENTAL

BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min

Intervention Type DRUG

BIBF 1120 twice daily along with standard therapy of PLD + CBDCA

BIBF 1120 (medium) + Carboplatin + PLD

BIBF 1120 (medium dose) + carboplatin (AUC5 mg/mL\*min) + PLD (30 mg/m2)

Group Type EXPERIMENTAL

BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min

Intervention Type DRUG

BIBF 1120 twice daily along with standard therapy of PLD + CBDCA

BIBF 1120 (high) + Carboplatin + PLD

BIBF 1120 (high dose) + carboplatin (AUC5 mg/mL\*min) + PLD (30 mg/m2)

Group Type EXPERIMENTAL

BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min

Intervention Type DRUG

BIBF 1120 twice daily along with standard therapy of PLD + CBDCA

Interventions

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BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min

BIBF 1120 twice daily along with standard therapy of PLD + CBDCA

Intervention Type DRUG

BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min

BIBF 1120 twice daily along with standard therapy of PLD + CBDCA

Intervention Type DRUG

BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min

BIBF 1120 twice daily along with standard therapy of PLD + CBDCA

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Female patients, age 20 years or older, with relapse of histologically (on initial diagnosis) confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer
2. Up to 3 lines of prior chemo therapy, with treatment free interval of \>6 months
3. Platinum based chemotherapy in the immediately preceding line.
4. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
5. Written informed consent that is consistent with Good Clinical Practice (GCP) guidelines

Exclusion Criteria

1. Prior chemotherapy with PLD, and any contraindication for therapy with carboplatin or PLD.
2. More than 2 lines of prior therapies that contained angiogenesis inhibitor.
3. Patients for whom surgery is planned, e.g. interval debulking surgery.
4. History of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months.
5. Serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy.
6. Laboratory values indicating an increased risk for adverse events.
7. Significant cardiovascular diseases.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1199.117.003 Boehringer Ingelheim Investigational Site

Akashi, Hyogo, , Japan

Site Status

1199.117.002 Boehringer Ingelheim Investigational Site

Chuo-ku,Tokyo, , Japan

Site Status

1199.117.001 Boehringer Ingelheim Investigational Site

Hidaka, Saitama, , Japan

Site Status

Countries

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Japan

Other Identifiers

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1199.117

Identifier Type: -

Identifier Source: org_study_id