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

NCT ID: NCT00710762

Last Updated: 2016-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2014-03-31

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.

Conditions

Ovarian Neoplasms

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION

Study Groups

BIBF1120

Group Type: EXPERIMENTAL

BIBF1120

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

BIBF1120

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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 < 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1199.9.4413 Boehringer Ingelheim Investigational Site

Burton-on-Trent, , United Kingdom

1199.9.4412 Boehringer Ingelheim Investigational Site

Cambridge, , United Kingdom

1199.9.4407 Boehringer Ingelheim Investigational Site

Creigiau, Cardiff, , United Kingdom

1199.9.4410 St James's University Hospital

Leeds, , United Kingdom

1199.9.4401 Boehringer Ingelheim Investigational Site

London, , United Kingdom

1199.9.4404 Boehringer Ingelheim Investigational Site

London, , United Kingdom

1199.9.4409 Boehringer Ingelheim Investigational Site

London, , United Kingdom

1199.9.4411 Boehringer Ingelheim Investigational Site

London, , United Kingdom

1199.9.4406 Boehringer Ingelheim Investigational Site

Manchester, , United Kingdom

1199.9.4402 Boehringer Ingelheim Investigational Site

Northwood, , United Kingdom

1199.9.4405 Boehringer Ingelheim Investigational Site

Sutton, , United Kingdom

Countries

United Kingdom

References

Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

Reference Type: DERIVED

PMID: 37185961 (View on PubMed)

Other Identifiers

EUDRACT2005-002427-14

Identifier Type: -

Identifier Source: secondary_id

1199.9

Identifier Type: -

Identifier Source: org_study_id

NCT00370175

Identifier Type: -

Identifier Source: nct_alias