CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 55 enrolled
Drug / intervention
BIBW 2992 low (20mg) dosage +5 moredrug
Likely dose
BIBW 2992 low (20mg) dosagefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00906698
NCT00906698Phase 1Completed

Phase I Open Label Trial to Assess Safety of BIBW 2992 With Vinorelbine in Solid Tumors Known to Overexpress HER2 and/or EGFR

Boehringer Ingelheim·interventional·Posted May 21, 2009·Updated Jun 9, 2014

In Brief

A Phase 1 clinical trial evaluating BIBW 2992 low (20mg) dosage, BIBW 2992 medium (40mg) dosage, and 4 other interventions for Neoplasms. Completed, enrolled 55 participants across 2 sites.

Detailed Summary

To determine the maximum tolerated dose, safety, pharmacokinetics and anti-tumour efficacy of oral BIBW 2992 in combination with intravenous or oral vinorelbine

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesFrance
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 21, 2009
Enrollment StartJun 1, 2009
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 17.1 years ago

Interventions

BIBW 2992 low (20mg) dosagedrug

Patients will receive 20mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine.

BIBW 2992 medium (40mg) dosagedrug

Patients will receive 40mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine.

BIBW 2992 high (50mg) dosagedrug

Patients will receive 50mg dosage of BIBW 2992 plus standard dosage of vinorelbine.

Vinorelbine per os 60 mg/m²drug

Patients will receive 60 mg/m² Vinorelbine per os at J1 J8 and J15

Vinorelbine per os 80 mg/m²drug

Patients will receive 80 mg/m² Vinorelbine per os at J22

Vinorelbine i.v. 25 mg/m²drug

Patients will receive 25 mg/m² of Vinorelbine i.v.