LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01015118
First received: November 9, 2009
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in first-line treatment of patients with advanced ovarian cancer. Safety information about BIBF1120/paclitaxel/carboplatin will be obtained.


Condition Intervention Phase
Ovarian Neoplasms
Peritoneal Neoplasms
Drug: Placebo
Drug: BIBF 1120
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Multicenter, Randomised, Double-blind Phase III Trial to Investigate the Efficacy and Safety of BIBF 1120 in Combination With Carboplatin and Paclitaxel Compared to Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • progression free survival [ Time Frame: 41 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression free survival according to Response Evaluation Criteria In Solid Tumors 1.1 criteria [ Time Frame: 41 months ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 41 months ] [ Designated as safety issue: No ]
  • time to tumour marker progression [ Time Frame: 41 months ] [ Designated as safety issue: No ]
  • objective response [ Time Frame: 41 months ] [ Designated as safety issue: No ]
  • incidence and intensity of adverse events [ Time Frame: 41 months ] [ Designated as safety issue: No ]
  • changes in safety laboratory parameters [ Time Frame: 41 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1375
Study Start Date: November 2009
Estimated Study Completion Date: July 2016
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIBF 1120
patients to receive BIBF 1120 standard dose twice daily PO in combination with combination with carboplatin and paclitaxel
Drug: BIBF 1120
comparison of BIBF 1120 in combination with chemotherapy and placebo in combination with chemotherapy (paclitaxel/carboplatin)
Placebo Comparator: Placebo
patients to receive capsules identical to those containing BIBF 1120 in combination with combination with carboplatin and paclitaxel
Drug: Placebo
comparator to BIBF 1120

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • first diagnosis of histologically confirmed epithelial ovarian cancer, fallopian tube or primary peritoneal cancer
  • International Federation of Gynecology and Obstetrics (FIGO) Stages IIB - IV
  • females, age 18 years or older
  • life expectancy of at least 6 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • prior surgery, defined as either (a) debulking surgery with maximum surgical effort at cytoreduction with the goal of no residual disease or (b) biopsy or limited surgery in patients with stage IV disease for whom surgical debulking was not considered appropriate, if diagnosis is confirmed by histology and no surgery is planned prior to disease progression (including interval debulking surgery)
  • patient has given written informed consent which must be consistent with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and local legislation
  • planned application of first dose of chemotherapy after wound healing, but no later than 10 weeks after surgery

Exclusion criteria:

  • histologic diagnosis of a benign or borderline tumour or of a malignant tumour of non-epithelial origin of the ovary, the fallopian tube or the peritoneum
  • planned surgery within 124 weeks after randomisation in this trial, including interval debulking surgery
  • clinically relevant non-healing wound, ulcer or bone fracture
  • clinical symptoms or signs of gastrointestinal obstruction that require parenteral nutrition or hydration
  • brain metastases
  • pre-existing sensory or motor neuropathy Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher, except due to trauma
  • history of major thromboembolic event
  • known inherited or acquired bleeding disorder
  • significant cardiovascular diseases
  • clinically relevant pericardial effusion
  • history of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months
  • inadequate safety laboratory values
  • serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy, including Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV)
  • poorly controlled diabetes mellitus or other contraindication to high dose corticosteroid therapy
  • gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
  • other malignancy diagnosed within the past 5 years. In exception to this rule, the following malignancies may be included if adequately treated: non-melanomatous skin cancer, cervical carcinoma in situ, carcinoma in situ of the breast, low risk endometrial cancer
  • prior systemic therapy for ovarian cancer (e.g. chemotherapy, monoclonal antibody therapy, oral targeted therapy, hormonal therapy)
  • prior systemic cytotoxic chemotherapy
  • prior treatment with BIBF 1120 or any other angiogenesis inhibitor
  • prior radiotherapy
  • serious illness or concomitant non-oncological disease such as neurologic, psychiatric or infectious disease or a laboratory abnormality that may increase the risk associated with study participation or study drug administration
  • Women of childbearing potential who are sexually active and not using a highly effective method of birth control during the trial and for at least twelve months after the end of active therapy.
  • pregnancy or breast feeding
  • psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
  • active alcohol or drug abuse
  • patients unable to comply with the protocol
  • any contraindications for therapy with paclitaxel or carboplatin
  • treatment with other investigational drugs or participation in another clinical trial testing a drug within the past four weeks before start of therapy or concomitantly with this trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015118

  Show 280 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01015118     History of Changes
Other Study ID Numbers: 1199.15, AGO-OVAR12, 2008-006831-10
Study First Received: November 9, 2009
Last Updated: March 27, 2014
Health Authority: Australia: Human Research Ethics Committee
Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: The Danish Health and Medicines Authority
Finland: Finnish Medicines Agency
France: Agence Nationale sécurité médicament et des produits santé
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Italy: Ethics Committee
Monaco: Ministère de l'Etat
Netherlands: Central Committee Research Involving Human Subjects
Norway: Norwegian Medicines Agency
Poland: Registration Medicinal Product Medical Device Biocidal Product
Portugal: National Pharmacy and Medicines Institute
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 23, 2014