Phase 1
Completed N=55
Afatinib and Vinorelbine in Tumours Known to Overexpress EGFR and/or HER2
Neoplasms
Source: ClinicalTrials.gov NCT00906698 ↗
Enrolled (actual)
55
Serious AEs
58.2%
Results posted
Apr 2014
Primary outcomePrimary: Number of Participants With Dose-limiting Toxicities (DLT) — 0; 1; 4; 0 participants
Summary
To determine the maximum tolerated dose, safety, pharmacokinetics and anti-tumour efficacy of oral BIBW 2992 in combination with intravenous or oral vinorelbine
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-limiting Toxicities (DLT) |
0; 1; 4; 0; 1; 3 | — |
| SECONDARY Number of Patients With Best Overall Response |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Patients With Objective Response (OR) |
0; 0; 0; 0; 3; 0 | — |
| SECONDARY Number of Patients With Disease Control (DC) |
1; 10; 5; 0; 9; 5 | — |
| SECONDARY Time to Objective Response |
55 | — |
| SECONDARY Duration of Objective Response |
114 | — |
| SECONDARY Duration of Disease Control |
110; 167; 168; 162; 120 | — |
| SECONDARY Best Percentage Change in Tumour Size |
-5.65; -7.51; -24.10; 25.89; -1.36; -10.76 | — |
| SECONDARY Progression-free Survival (PFS) |
14.6; 15.9 | — |
| SECONDARY Area Under the Concentration-time Curve of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State |
892; 683 | — |
| SECONDARY Area Under the Concentration-time Curve of Vinorelbine After Single and Multiple Intravenous Administrations of 25mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State |
512; 655 | — |
| SECONDARY Maximum Measured Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State |
62.0; 42.7 | — |
| SECONDARY Maximum Measured Concentration of Vinorelbine After Single and Multiple Intravenous Administrations of 25 mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State |
822; 941 | — |
| SECONDARY Time From Dosing to the Maximum Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State |
3.16; 2.00 | — |
| SECONDARY Time From Dosing to the Maximum Concentration of Vinorelbine After Single and Multiple Intravenous Administrations of 25mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State |
0.166; 0.167 | — |
| SECONDARY Area Under the Concentration-time Curve of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 60mg/m^2 Per os Vinorelbine at Steady State |
872; 1070 | — |
| SECONDARY Area Under the Concentration-time Curve of Vinorelbine After Multiple Administrations Per os of 60mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State |
258; 334 | — |
| SECONDARY Maximum Measured Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 Per os Vinorelbine at Steady State |
55.1; 67.2 | — |
| SECONDARY Maximum Measured Concentration of Vinorelbine After Multiple Administrations Per os of 60mg/m^2 in Presence and Absence of Afatinib at Steady State |
52.8; 65.0 | — |
| SECONDARY Time From Dosing to the Maximum Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 60mg/m^2 Per os Vinorelbine at Steady State |
3.54; 3.00 | — |
| SECONDARY Time From Dosing to the Maximum Concentration of Vinorelbine After Single and Multiple Administrations of 60mg/m^2 Vinorelbine Per os in Presence and Absence of Afatinib at Steady State |
1.50; 1.50 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00906698). 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.