Phase 1
Completed N=41
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
Neoplasms
Source: ClinicalTrials.gov NCT00715403 ↗
Enrolled (actual)
41
Serious AEs
24.4%
Results posted
Dec 2014
Primary outcomePrimary: Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 — 100; 0; 0; 11 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 |
100; 0; 0; 11; 0; 0 | — |
| PRIMARY Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2 |
0; 0; 0; 22; 0; 11 | — |
| PRIMARY Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3 |
100; 0; 0; 0; 0; 0 | — |
| PRIMARY Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5 |
0; 0; 0; 0; 0; 5 | — |
| PRIMARY Difference From Baseline for Liver Enzymes |
127.0; 11.9; -39.0; -21.2; -11.7; 16.0 | — |
| PRIMARY Difference From Baseline for Bilirubin, Creatinine and Glucose |
0.5; 0.0; 0.0; 0.0; 0.1; 0.1 | — |
| PRIMARY Difference From Baseline for Haemoglobin |
-1.8; 1.4; 0.4; 1.0; 1.2; -0.2 | — |
| PRIMARY Difference From Baseline for Haematology and Differentials Parameters |
42.2; 11.1; 1.0; -2.5; -38.1; 11.2 | — |
| PRIMARY Difference From Baseline for Coagulation Parameters |
0.1; 0.1; 0.3; 0.1; 0.2; -0.0 | — |
| PRIMARY Difference From Baseline for Electrolytes |
0.2; -0.3; -0.3; 0.1; -0.0; 0.1 | — |
| SECONDARY Clinically Relevant Abnormalities for Vital Signs |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss) |
7.54; 11.8; 11.0 | — |
| SECONDARY Unconfirmed Best Overall Response |
0; 100; 0; 0; 0; 0 | — |
| SECONDARY Unconfirmed Best Objective Response |
100; 0; 100; 56; 100; 53 | — |
| SECONDARY Clinical Benefit |
0; 0; 0; 0; 0; 11 | — |
| SECONDARY Confirmed Objective Response |
100; 0; 100; 56; 100; 58 | — |
| SECONDARY Progression Free Survival |
0; 100; 25; 11; 33; 42 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT00715403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.