Phase 1
Completed N=43
BIBF 1120 + Docetaxel (Japan) in Patients With Advanced Non-small-cell Lung Cancer, Phase I
Source: ClinicalTrials.gov NCT00876460 ↗Enrolled (actual)
43
Serious AEs
35.7%
Results posted
Dec 2014
Primary outcomePrimary: Number of Participants Who Experienced Dose Limited Toxicity in Combination Therapy of Nintedanib and Docetaxel — 0; 2; 0; 1 Participants
Summary
To confirm the safety of BIBF 1120 at a dose level up to 200 mg x 2/day (i.e., overseas recommended Phase III dose for combination treatment) with standard therapy of docetaxel (60 mg/m2 and 75 mg/m2) in Japanese advanced non small cell lung cancer (NSCLC) patients with stage IIIB/IV or recurrent after failure of first line chemotherapy and to determine the recommended dose for the Phase II trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Dose Limited Toxicity in Combination Therapy of Nintedanib and Docetaxel |
0; 2; 0; 1; 2; 3 | — |
| PRIMARY Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Objective Tumor Response |
0; 2; 5; 2; 1; 3 | — |
| SECONDARY Disease Control |
2; 5; 12; 5; 4; 1 | — |
| SECONDARY Progression-Free Survival (PFS) |
229.5; 117.0; 139.0; 351.0; 184.0 | — |
| SECONDARY Time to Treatment Failure (TTF) |
200.0; 83.5; 134.0; 87.0; 176.0 | — |
| SECONDARY Clinical Relevant Abnormalities in Laboratory Parameters |
2; 4; 0; 5; 4; 3 | — |
| SECONDARY AUC0-inf of Nintedanib in Course 1 |
169; 260; 349 | — |
| SECONDARY Cmax of Nintedanib in Course 1 |
29.3; 33.4; 59.9 | — |
| SECONDARY AUC0-inf of Docetaxel in Course 1 |
3270; 3810 | — |
| SECONDARY Cmax of Docetaxel in Course 1 |
3150; 3550 | — |
| SECONDARY AUC0-inf of Docetaxel in Course 2 |
2320; 3750; 4270 | — |
| SECONDARY Cmax of Docetaxel in Course 2 |
1870; 3740; 4070 | — |
Eligibility Criteria
Inclusion criteria
- Histologically/cytologically confirmed, locally advanced/metastatic NSCLC of stage IIIB/IV or recurrent NSCLC (all histologies. Existence or nonexistence of measurable lesion according to RECIST is no object.)
- Patients with one prior chemotherapy regimen including platinum-containing drug.
In case of recurrent disease, one additional prior regimen is allowed for adjuvant and/or neoadjuvant therapy. However monotherapy of EGFR-TKI (i.e. erlotinib/Tarceva® and gefitinib/Iressa®) is not counted as 'one regimen'.
- Male or female patients age >=20 years and = NYHA II, serious cardiac arrhythmia, pericardial effusion)
- Significant weight loss (> 10 %) within the past 6 weeks prior to registration in the this trial
- Current peripheral neuropathy >= CTCAE grade 2 except due to trauma.
- Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment
- Major injuries and/or surgery within the past 10 days prior to registration with incomplete wound healing.
- Serious infections requiring systemic antibiotic (e.g antiviral, antimicrobial, antifungal) therapy.
- Decompensated diabetes mellitus or other contraindication to high dose corticosteroid therapy.
- Gastrointestinal disorders or abnormalities (e.g Crohn's disease, Colitis ulcerosa and extensive gastrectomy) that would interfere with absorption of the study drug.
- Patients with difficulty in swallowing study medication
- Patients with positive HBs antigen, HCV antibody, or HIV antibody test
- 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 trial participation or investigational drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the trial.
- Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least 12 months after end of active therapy
- Female patients who are pregnant, breast feeding and may become pregnant.
- Patients who have or is suspected of having active alcohol or drug abuse.
- Patient with clinically meaningful drug hypersensitivities.
- Patients with auto immune disease.
- Patients unable to comply with the protocol.
- Other patients judged ineligible for enrolment in the study by the investigator.
Data sourced from ClinicalTrials.gov (NCT00876460). 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.