A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian Cancer

A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian Cancer

The primary objective of this study is to estimate the Progression Free Survival Rates (PFS) of patients with relapsed ovarian cancer after 9 months of continuous treatment with either BIBF 1120 or matching placebo.

Inclusion Criteria:

• Female patients with histologically confirmed advanced ovarian carcinoma, fallopian tube carcinoma or primary peritoneal cancer of serous type with recurrent disease and who responded to 2nd, 3rd or 4th line chemotherapy. Response is defined as either a confirmed decline in CA125 of at least 50% from the pre-treatment value or an Objective Response, i.e. a Partial Response (PR) or Complete Response (CR) according to the RECIST criteria in patients with measurable disease.
• Treatment-free interval of < 12 months since commencing prior treatment regimen for relapsed ovarian cancer.
• Full recovery from all therapy related toxicities of previous chemotherapy and or radiotherapy or recovery in as much as no further improvement may be expected by the investigator.
• Age > 18 years.
• Life expectancy of at least 3 months.
• ECOG Performance Score < 2.
• Adequate hepatic function: total bilirubin 26µmol/L, ALT and/or AST 1.5x upper limit of normal (ULN). INR, Prothrombin time (PT) and partial thromboplastin time (PTT): maximum 50% deviation from normal limits.
• Adequate renal function: serum creatinine 1.5 x ULN.
• Absolute neutrophil count (ANC) >1.5 x 109l, Platelets > 100 x 109/l, Haemoglobin > 9.0 g/dl.
• Written informed consent consistent with ICH-GCP guidelines.
• Minimum time elapsed since last chemotherapy (including hormonal treatment other than Hormone Replacement Therapy [HRT]) or immunotherapy and the first administration of BIBF 1120 must be more than 4 but less than 8 weeks.

Exclusion Criteria:

• Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study.
• Major injuries and/or surgery within past 4 weeks with incomplete wound healing or bone fracture and planned surgical procedures during the study period.
• Hypersensitivity to BIBF 1120 or the excipients of the study drug.
• Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 9 months, congestive heart failure > NYHA II).
• History of haemorrhagic or thrombotic event in the past 12 months. Known inherited predisposition to bleeds or to thrombosis.
• Patients who require full-dose anticoagulation.
• Gastrointestinal disorders or abnormalities that would inhibit absorption of the study drug.
• Brain metastases or leptomeningeal disease.
• Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial.
• Chemo-, radio-, or immunotherapy within the past four weeks prior to treatment with the trial drug.
• Patients unable to comply with the protocol.
• Active alcohol or drug abuse.
• Other documented malignancy with the exception of non-melanomatous skin cancer within the past 5 years.
• Patients who are not clinically sterile.