Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 objec...
Eligibility Criteria
Inclusion
- 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.
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score \<= 2
- Patients must have given written informed consent (which must be consistent with ICH-GCP and local legislation)
Exclusion
- Time elapsed from last administration of BIBF 1120 in the previous trial to start of treatment in the present trial exceeds four weeks
- 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
- Active ulcers (gastro-intestinal tract, skin)
- Major injuries and surgery within the past three weeks with incomplete wound healing
- Hypersensitivity to BIBF 1120 or the excipients of the trial drug
- Known secondary malignancy requiring therapy
- Active infectious disease
- Significant cardiovascular diseases (i.e. uncontrolled severe hypertension, unstable angina pectoris, history of myocardial infarction, congestive heart failure \> NYHA II)
- Gastrointestinal disorders anticipated to interfere with the resorption of the study drug
- Brain metastases requiring therapy
- Absolute neutrophil count less than 1,500/mm3
- Platelet count less than 100,000/mm3
- Bilirubin greater than 1.5 mg/dl (\> 26 µmol/L)
- 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)
- Serum creatinine greater than 2 mg/dl (\> 176 µmol/L)
- Concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
- Chemo-, radio-, or immunotherapy within the past four weeks prior to treatment with the trial drug
- Patients who are sexually active and unwilling to use a medically acceptable method of contraception
- Pregnancy or lactation
- 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)
- Patients unable to comply with the protocol
- Active alcohol or drug abuse
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00715403
Start Date
October 1 2004
Last Update
December 2 2014
Active Locations (11)
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1
1199.16.3306A Boehringer Ingelheim Investigational Site
Bordeaux, France
2
1199.16.3311A Boehringer Ingelheim Investigational Site
Clichy, France
3
1199.16.3311B Boehringer Ingelheim Investigational Site
Clichy, France
4
1199.16.3302A Boehringer Ingelheim Investigational Site
Paris, France