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

Boehringer Ingelheim11 sites in 1 country89 target enrollmentMarch 2006

ConditionsOvarian Neoplasms

InterventionsBIBF1120 Placebo

DrugsBIBF1120 Placebo

Overview

Phase: Phase 2
Intervention: BIBF1120
Conditions: Ovarian Neoplasms
Sponsor: Boehringer Ingelheim
Enrollment: 89
Locations: 11
Primary Endpoint: PFS Rate at 36 Weeks (After 9 Months)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

March 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

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 \<
•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.

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.

Arms & Interventions

BIBF1120

Intervention: BIBF1120

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

PFS Rate at 36 Weeks (After 9 Months)

Time Frame: 36 weeks (after 9 months)

The rate (probability) of being progression free at Week 36. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.

Secondary Outcomes

PFS Rate at 12 Weeks (After 3 Months) and 24 Weeks ( After 6 Months)(12 weeks (after 3 months) and 24 weeks ( after 6 months))
Time to Death(9 months)
Incidence and Intensity of Adverse Events With Grading According CTCAE(First drug administration until 28 days after last drug administration,up until 309 days)
Time to Tumour Progression(9 months)
Clinical Relevant Abnormalities for Laboratory Parameters(First drug administration until 28 days after last drug administration, up until 309 days)