Clinical trial · Interventional
Afatinib and Vinorelbine in Tumours Known to Overexpress EGFR and/or HER2
Phase I Open Label Trial to Assess Safety of BIBW 2992 With Vinorelbine in Solid Tumors Known to Overexpress HER2 and/or EGFR
NCT00906698CI-TRIAL-00014804completedPhase 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 determine the maximum tolerated dose, safety, pharmacokinetics and anti-tumour efficacy of oral BIBW 2992 in combination with intravenous or oral vinorelbine
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIBW 2992 high (50mg) dosage | Drug | — | UNRESOLVED |
| BIBW 2992 low (20mg) dosage | Drug | — | UNRESOLVED |
| BIBW 2992 medium (40mg) dosage | Drug | — | UNRESOLVED |
| Vinorelbine i.v. 25 mg/m² | Drug | — | UNRESOLVED |
| Vinorelbine per os 60 mg/m² | Drug | — | UNRESOLVED |
| Vinorelbine per os 80 mg/m² | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BIBW 2992 and vinorelbine i.v
- description
- Daily low (20mg), medium (40mg) and high (50mg) dosages of BIBW 2992 with standard dosage of vinorelbine i.v.
- interventionNames
- Drug: BIBW 2992 low (20mg) dosage
- Drug: BIBW 2992 medium (40mg) dosage
- Drug: BIBW 2992 high (50mg) dosage
- Drug: Vinorelbine i.v. 25 mg/m²
- type
- EXPERIMENTAL
- label
- BIBW 2992 and vinorelbine per os
- description
- Daily low (20mg), medium (40mg) and high (50mg) dosages of BIBW 2992 with standard dosage of vinorelbine per os.
- interventionNames
- Drug: BIBW 2992 low (20mg) dosage
- Drug: BIBW 2992 medium (40mg) dosage
- Drug: BIBW 2992 high (50mg) dosage
- Drug: Vinorelbine per os 60 mg/m²
- Drug: Vinorelbine per os 80 mg/m²
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Histologically or cytologically confirmed diagnosis of malignancy that is now advanced, non resectable and/or metastatic * Tumours historically known to overexpress EGFR and/or HER2 Exclusion criteria: * Prior treatment with HER2 inhibiting drugs within the past 4 weeks before the start of therapy or concomitantly with this trial. * Prior treatment with EGFR inhibiting drugs within the past two weeks before the start of therapy or concomitantly with this trial.
References
Publications (0)
Data not yet available
No reference posted for this study.