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Multicenter, Randomised, Double-blind Phase III Trial to Investigate the Efficacy and Safety of BIBF 1120 in Combination With Carboplatin and Paclitaxel Compared to Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer

Phase 3
18 Years
Open (Enrolling)
Ovarian Neoplasms, Peritoneal Neoplasms

Thank you

Trial Information

Multicenter, Randomised, Double-blind Phase III Trial to Investigate the Efficacy and Safety of BIBF 1120 in Combination With Carboplatin and Paclitaxel Compared to Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer

Inclusion Criteria

Inclusion criteria:

- first diagnosis of histologically confirmed epithelial ovarian cancer, fallopian tube
or primary peritoneal cancer

- International Federation of Gynecology and Obstetrics (FIGO) Stages IIB - IV

- females, age 18 years or older

- life expectancy of at least 6 months

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

- prior surgery, defined as either (a) debulking surgery with maximum surgical effort
at cytoreduction with the goal of no residual disease or (b) biopsy or limited
surgery in patients with stage IV disease for whom surgical debulking was not
considered appropriate, if diagnosis is confirmed by histology and no surgery is
planned prior to disease progression (including interval debulking surgery)

- patient has given written informed consent which must be consistent with the
International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and
local legislation

- planned application of first dose of chemotherapy after wound healing, but no later
than 10 weeks after surgery

Exclusion criteria:

- histologic diagnosis of a benign or borderline tumour or of a malignant tumour of
non-epithelial origin of the ovary, the fallopian tube or the peritoneum

- planned surgery within 124 weeks after randomisation in this trial, including
interval debulking surgery

- clinically relevant non-healing wound, ulcer or bone fracture

- clinical symptoms or signs of gastrointestinal obstruction that require parenteral
nutrition or hydration

- brain metastases

- pre-existing sensory or motor neuropathy Common Terminology Criteria for Adverse
Events (CTCAE) grade 2 or higher, except due to trauma

- history of major thromboembolic event

- known inherited or acquired bleeding disorder

- significant cardiovascular diseases

- clinically relevant pericardial effusion

- history of a cerebral vascular accident, transient ischemic attack or subarachnoid
haemorrhage within the past 6 months

- inadequate safety laboratory values

- serious infections in particular if requiring systemic antibiotic (antimicrobial,
antifungal) or antiviral therapy, including Hepatitis B, Hepatitis C, Human
Immunodeficiency Virus (HIV)

- poorly controlled diabetes mellitus or other contraindication to high dose
corticosteroid therapy

- gastrointestinal disorders or abnormalities that would interfere with absorption of
the study drug

- other malignancy diagnosed within the past 5 years. In exception to this rule, the
following malignancies may be included if adequately treated: non-melanomatous skin
cancer, cervical carcinoma in situ, carcinoma in situ of the breast, low risk
endometrial cancer

- prior systemic therapy for ovarian cancer (e.g. chemotherapy, monoclonal antibody
therapy, oral targeted therapy, hormonal therapy)

- prior systemic cytotoxic chemotherapy

- prior treatment with BIBF 1120 or any other angiogenesis inhibitor

- prior radiotherapy

- serious illness or concomitant non-oncological disease such as neurologic,
psychiatric or infectious disease or a laboratory abnormality that may increase the
risk associated with study participation or study drug administration

- Women of childbearing potential who are sexually active and not using a highly
effective method of birth control during the trial and for at least twelve months
after the end of active therapy.

- pregnancy or breast feeding

- psychological, familial, sociological or geographical factors potentially hampering
compliance with the study protocol and follow-up schedule

- active alcohol or drug abuse

- patients unable to comply with the protocol

- any contraindications for therapy with paclitaxel or carboplatin

- treatment with other investigational drugs or participation in another clinical trial
testing a drug within the past four weeks before start of therapy or concomitantly
with this trial

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Time Frame:

41 months

Safety Issue:


Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals


Australia: Human Research Ethics Committee

Study ID:




Start Date:

November 2009

Completion Date:

July 2016

Related Keywords:

  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms



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