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An Open-label, Dose Escalation Phase I Study of the Safety and Tolerability of BIBF 1120 in Combination With Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Japanese Patients With a First, Second or Third Platinum-sensitive Relapse of Advanced Epithelial Ovarian Cancer, Fallopian Tube or Primary Peritoneal Cancer.


Phase 1
20 Years
N/A
Not Enrolling
Female
Ovarian Neoplasms

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Trial Information

An Open-label, Dose Escalation Phase I Study of the Safety and Tolerability of BIBF 1120 in Combination With Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Japanese Patients With a First, Second or Third Platinum-sensitive Relapse of Advanced Epithelial Ovarian Cancer, Fallopian Tube or Primary Peritoneal Cancer.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine Maximum tolerated dose of BIBF 1120 in combination with carboplatin and PLD based on number of Dose Limiting Toxicity (DLT) at each dose level

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

1199.117

NCT ID:

NCT01329549

Start Date:

April 2011

Completion Date:

October 2012

Related Keywords:

  • Ovarian Neoplasms
  • Neoplasms
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms

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