Clinical trial · Interventional
BIBW 2992 (Afatinib) and Vinorelbine in Japanese Patients With Advanced Solid Tumours
An Open-label Phase I Study of Once Daily Oral Treatment With BIBW 2992 in Combination With Weekly Vinorelbine Intravenous Injection in Japanese Patients With Advanced Solid Tumours
NCT01214616CI-TRIAL-00085665completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- afatinib and vinorelbine IV
- description
- patient to receive 20mg or 40mg of po daily afatinib in combination with vinorelbine IV
- interventionNames
- Drug: afatinib 20mg
- Drug: afatinib 40mg
- Drug: vinorelbine IV 25 or 20mg/m2
Primary outcomes (2)
- measure
- Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course
- timeFrame
- during 1st course
- description
- DLTs and Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine iv. (MTD = not determined)
- measure
- Drug-related Adverse Events
- timeFrame
- during the treatment period or up to 28 days after the completion of drug administration, up to 730 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.