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A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian Cancer
This study has been completed.
First Received: July 3, 2008   Last Updated: February 11, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00710762
  Purpose

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.


Condition Intervention Phase
Ovarian Neoplasms
Drug: BIBF1120
Phase II

Study Type: Interventional
Study Design: Prevention, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 84
Study Start Date: March 2006
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710762

Locations
United Kingdom
1199.9.4409 Boehringer Ingelheim Investigational Site
London, United Kingdom
1199.9.4410 St James's University Hospital
Leeds, United Kingdom
1199.9.4402 Boehringer Ingelheim Investigational Site
Northwood, United Kingdom
1199.9.4404 Boehringer Ingelheim Investigational Site
London, United Kingdom
1199.9.4406 Boehringer Ingelheim Investigational Site
Manchester, United Kingdom
1199.9.4401 Boehringer Ingelheim Investigational Site
London, United Kingdom
1199.9.4412 Boehringer Ingelheim Investigational Site
Cambridge, United Kingdom
1199.9.4411 Boehringer Ingelheim Investigational Site
London, United Kingdom
1199.9.4405 Boehringer Ingelheim Investigational Site
Sutton, United Kingdom
1199.9.4413 Boehringer Ingelheim Investigational Site
Burton on Trent, United Kingdom
1199.9.4407 Boehringer Ingelheim Investigational Site
Creigiau, Cardiff, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1199.9, EUDRACT2005-002427-14
Study First Received: July 3, 2008
Last Updated: February 11, 2009
ClinicalTrials.gov Identifier: NCT00710762     History of Changes
Health Authority: Great Britain: MHRA

Study placed in the following topic categories:
Genital Diseases, Female
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Ovarian Cancer
Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009