Phase 1
Completed N=17
BIBW 2992 (Afatinib) and Vinorelbine in Japanese Patients With Advanced Solid Tumours
Neoplasms
Source: ClinicalTrials.gov NCT01214616 ↗
Enrolled (actual)
17
Serious AEs
47.1%
Results posted
Jul 2014
Primary outcomePrimary: Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course — 0; 3; 0; 1 participants
Summary
* To identify the Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine i.v. by assessment of Dose Limiting Toxicities (DLT);
* To assess safety and anti-tumour efficacy and determine pharmacokinetic characteristics of afatinib and vinorelbine i.v.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course |
0; 3; 0; 1 | — |
| PRIMARY Drug-related Adverse Events |
3; 5; 3; 6 | — |
| SECONDARY AUCτ,ss for Afatinib |
329; 404; 866; 1010 | — |
| SECONDARY Cmax,ss for Afatinib |
28.8; 19.6; 52.5; 57.1 | — |
| SECONDARY AUC0-∞ for Vinorelbine |
763; 691; 934; 860 | — |
| SECONDARY Cmax for Vinorelbine |
1120; 1380; 1160; 1330 | — |
| SECONDARY Objective Tumour Response |
0; 0; 1; 1 | — |
Eligibility Criteria
Inclusion criteria
- Histologically confirmed diagnosis of malignancy that is advanced and for which standard therapies do not exist or are no longer effective.
- Life expectancy at least 12 weeks
- Eastern Cooperative Oncology Group Performance Status 0 or 1
- Adequate hepatic, renal, haematologic and other organ function
- Written informed consent
Exclusion criteria
- Chemotherapy, immunotherapy, surgery and radiotherapy within the past 4 weeks
- Prior treatment with afatinib and or vinorelbine
- Clinically significant active infectious disease
Data sourced from ClinicalTrials.gov (NCT01214616). 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.