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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00710762 |
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 |
Enrollment: | 84 |
Study Start Date: | March 2006 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
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 |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
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 |
Genital Diseases, Female Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Ovarian Cancer |
Endocrine System Diseases Urogenital Neoplasms Endocrinopathy Ovarian Diseases Endocrine Gland Neoplasms |
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 |