A Phase I/II Open Label Extension Study of BIBF 1120 Administered Orally Once or Twice Daily to Establish Safety, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and Clinical Benefit From Previous Therapy With BIBF 1120

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00715403
First received: July 11, 2008
Last updated: January 13, 2010
Last verified: January 2010
  Purpose

The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms of incidence and intensity of Adverse Events and changes in safety laboratory parameters.

Secondary objectives are the collection of further safety data (vital signs), efficacy data and the determination of pharmacokinetic characteristics during long-term therapy with BIBF 1120.


Condition Intervention Phase
Neoplasms
Drug: BIBF 1120
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: Extension Study to Establish Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Patients With Previous Clinical Benefit From BIBF 1120

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) and changes in safety laboratory parameters

Secondary Outcome Measures:
  • 1) Vital signs 2) Pharmacokinetics 3) Assessment of tumour response 4) Time to tumour progression

Enrollment: 41
Study Start Date: October 2004
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  1. Male or female patients with advanced solid tumours who have completed a previous study with BIBF 1120. The patients should not have progression of their underlying tumour disease unless there is evidence for significant clinical benefit (e.g. symptom improvement) from treatment with BIBF 1120.
  2. Age 18 years or older
  3. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score <= 2
  4. Patients must have given written informed consent (which must be consistent with ICH-GCP and local legislation)

Exclusion Criteria:

  1. Time elapsed from last administration of BIBF 1120 in the previous trial to start of treatment in the present trial exceeds four weeks
  2. Presence of drug related toxicity > grade 2 CTC from previous therapy with BIBF 1120 or presence of drug related continuous toxicity of grade 2 for seven or more consecutive days which would preclude ongoing chronic therapy with BIBF 1120
  3. Active ulcers (gastro-intestinal tract, skin)
  4. Major injuries and surgery within the past three weeks with incomplete wound healing
  5. Hypersensitivity to BIBF 1120 or the excipients of the trial drug
  6. Known secondary malignancy requiring therapy
  7. Active infectious disease
  8. Significant cardiovascular diseases (i.e. uncontrolled severe hypertension, unstable angina pectoris, history of myocardial infarction, congestive heart failure > NYHA II)
  9. Gastrointestinal disorders anticipated to interfere with the resorption of the study drug
  10. Brain metastases requiring therapy
  11. Absolute neutrophil count less than 1,500/mm3
  12. Platelet count less than 100,000/mm3
  13. Bilirubin greater than 1.5 mg/dl (> 26 µmol/L)
  14. Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
  15. Serum creatinine greater than 2 mg/dl (> 176 µmol/L)
  16. Concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
  17. Chemo-, radio-, or immunotherapy within the past four weeks prior to treatment with the trial drug
  18. Patients who are sexually active and unwilling to use a medically acceptable method of contraception
  19. Pregnancy or lactation
  20. Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy (visit 2) or concomitantly with this trial (except for a previous study with BIBF 1120)
  21. Patients unable to comply with the protocol
  22. Active alcohol or drug abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715403

Locations
France
1199.16.3306A Boehringer Ingelheim Investigational Site
Bordeaux Cedex, France
1199.16.3311A Boehringer Ingelheim Investigational Site
Clichy Cedex, France
1199.16.3311B Boehringer Ingelheim Investigational Site
Clichy Cedex, France
1199.16.3312A Boehringer Ingelheim Investigational Site
Paris, France
1199.16.3313A Boehringer Ingelheim Investigational Site
Paris Cedex 10, France
1199.16.3313E Boehringer Ingelheim Investigational Site
Paris Cedex 10, France
1199.16.3302A Boehringer Ingelheim Investigational Site
Paris Cedex 15, France
Germany
1199.16.49001 Boehringer Ingelheim Investigational Site
Freiburg/Breisgau, Germany
1199.16.49004 Boehringer Ingelheim Investigational Site
Grosshansdorf, Germany
1199.16.49008 Boehringer Ingelheim Investigational Site
Tübingen, Germany
1199.16.49005 Boehringer Ingelheim Investigational Site
Wiesbaden, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00715403     History of Changes
Other Study ID Numbers: 1199.16
Study First Received: July 11, 2008
Last Updated: January 13, 2010
Health Authority: France: AFFSAPS
Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 22, 2014