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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00710762
• Date of registration: 03/07/2008
• Primary sponsor: Boehringer Ingelheim Pharmaceuticals
• Public title: A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian Cancer
• Scientific title: A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian Cancer
• Date of first enrolment: March 2006
• Target sample size: 84
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00710762
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Prevention

Countries of recruitment

United Kingdom

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim Pharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Ovarian Neoplasms

Intervention(s)

Drug: BIBF1120

Primary Outcome(s)

Progression Free Survival Rate (PFS) after 9 months of twice daily dosing of study treatment. [Time Frame: 9 months]

Secondary Outcome(s)

Time to Tumour Progression according to RECIST and the tumour marker CA125, PFS rate after 3 months and 6 months of twice daily dosing of study treatment, Survival and Incidence and intensity of Adverse Events [Time Frame: 9 months]

Secondary ID(s)

1199.9

EUDRACT2005-002427-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors