Clinical trial NCT00715403: 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
Official title: Extension Study to Establish Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Patients With Previous Clinical Benefit From BIBF 1120
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-07-15
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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 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.


Eligibility 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

Primary outcomes:
measure: Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1
timeFrame: From signing the informed consent until final follow-up, up to 991 days
measure: Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2
timeFrame: From signing the informed consent until final follow-up, up to 991 days
measure: Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3
timeFrame: From signing the informed consent until final follow-up, up to 991 days
measure: Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4
timeFrame: From signing the informed consent until final follow-up, up to 991 days
measure: Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5
timeFrame: From signing the informed consent until final follow-up, up to 991 days
measure: Difference From Baseline for Liver Enzymes
timeFrame: From signing the informed consent until end of treatment, up to 991 days
measure: Difference From Baseline for Bilirubin, Creatinine and Glucose
timeFrame: From signing the informed consent until end of treatment, up to 991 days
measure: Difference From Baseline for Haemoglobin
timeFrame: From baseline until end of treatment, up to 991 days
measure: Difference From Baseline for Haematology and Differentials Parameters
timeFrame: From signing the informed consent until end of treatment, up to 991 days
measure: Difference From Baseline for Coagulation Parameters
timeFrame: From signing the informed consent until end of treatment, up to 991 days
measure: Difference From Baseline for Electrolytes
timeFrame: From signing the informed consent until end of treatment, up to 991 days
Secondary outcomes:
measure: Clinically Relevant Abnormalities for Vital Signs
timeFrame: From baseline until final follow-up, up to 991 days
measure: Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss)
timeFrame: Just before drug administration every 28±7 days after day 29
measure: Unconfirmed Best Overall Response
timeFrame: Baseline until end of treatment, up to 991 days
measure: Unconfirmed Best Objective Response
timeFrame: Baseline until end of treatment, up to 991 days
measure: Clinical Benefit
timeFrame: Baseline until end of treatment, up to 991 days
measure: Confirmed Objective Response
timeFrame: Baseline until end of treatment, up to 991 days
measure: Progression Free Survival
timeFrame: First drug administration (in previous trial) until end of treatment, up to 1230 days
Other outcomes:
Locations:
city: Bordeaux cedex
country: France
facility: 1199.16.3306A Boehringer Ingelheim Investigational Site
city: Clichy Cedex
country: France
facility: 1199.16.3311A Boehringer Ingelheim Investigational Site
city: Clichy Cedex
country: France
facility: 1199.16.3311B Boehringer Ingelheim Investigational Site
city: Paris Cedex 10
country: France
facility: 1199.16.3313A Boehringer Ingelheim Investigational Site
city: Paris Cedex 10
country: France
facility: 1199.16.3313E Boehringer Ingelheim Investigational Site
city: Paris cedex 15
country: France
facility: 1199.16.3302A Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1199.16.3312A Boehringer Ingelheim Investigational Site
city: Freiburg/Breisgau
country: Germany
facility: 1199.16.49001 Boehringer Ingelheim Investigational Site
city: Grosshansdorf
country: Germany
facility: 1199.16.49004 Boehringer Ingelheim Investigational Site
city: Tübingen
country: Germany
facility: 1199.16.49008 Boehringer Ingelheim Investigational Site
city: Wiesbaden
country: Germany
facility: 1199.16.49005 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: