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

NCT00710762 | Completed Phase 2 Results

• 2 other identifiers: 1199.9EUDRACT2005-002427-14
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 11

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

Outcome Measures

Primary Outcomes (1)

• PFS Rate at 36 Weeks (After 9 Months)

  The rate (probability) of being progression free at Week 36. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.

  36 weeks (after 9 months)

Secondary Outcomes (5)

• PFS Rate at 12 Weeks (After 3 Months) and 24 Weeks ( After 6 Months)

  12 weeks (after 3 months) and 24 weeks ( after 6 months)

• Time to Tumour Progression

  9 months

• Time to Death

  9 months

• Incidence and Intensity of Adverse Events With Grading According CTCAE

  First drug administration until 28 days after last drug administration,up until 309 days

• Clinical Relevant Abnormalities for Laboratory Parameters

  First drug administration until 28 days after last drug administration, up until 309 days

Study Arms (2)

BIBF1120

EXPERIMENTAL

Drug: BIBF1120

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIBF1120 DRUG

BIBF1120

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (11)

1199.9.4413 Boehringer Ingelheim Investigational Site

Burton-on-Trent, United Kingdom

Location

1199.9.4412 Boehringer Ingelheim Investigational Site

Cambridge, United Kingdom

Location

1199.9.4407 Boehringer Ingelheim Investigational Site

Creigiau, Cardiff, United Kingdom

Location

1199.9.4410 St James's University Hospital

Leeds, United Kingdom

Location

1199.9.4401 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1199.9.4404 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1199.9.4409 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1199.9.4411 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1199.9.4406 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

1199.9.4402 Boehringer Ingelheim Investigational Site

Northwood, United Kingdom

Location

1199.9.4405 Boehringer Ingelheim Investigational Site

Sutton, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37185961 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Limitations and Caveats

Data from all randomised patients collected upto NOV'08 were included in all above sections,unless stated otherwise.5 patients continued on BIBF1120 after database lock(DBL)-NOV'08 upto Mar'14,but due to limited data no further analyses were done.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2008
• First Posted: July 4, 2008
• Study Start: March 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: March 1, 2014
• Last Updated: August 15, 2016
• Results First Posted: December 4, 2014

Record last verified: 2016-07

Locations

GB (11)