CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 83 enrolled
Drug / intervention
Paclitaxel +9 moredrug
Likely dose
Paclitaxel 80mg/m2from 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/NCT00809133
NCT00809133Phase 1Completed
CompareCT.gov

A Phase I Open Label Trial of Continuous Dosing With BIBW 2992 Combined With Paclitaxel and BIBW 2992 Combined With Paclitaxel and Bevacizumab, BIBW 2992 Combined With Carboplatin and BIBW 2992 Combined With Paclitaxel and Carboplatin in Patients With Advanced Solid Tumours

Boehringer Ingelheim·interventional·Posted Dec 17, 2008·Updated Mar 14, 2016

In Brief

A Phase 1 clinical trial evaluating Paclitaxel, Carboplatin, and 3 other interventions for Neoplasms. Completed, enrolled 83 participants across 2 sites.

Detailed Summary

The main purpose of this study is to assess the optimum dose of the following medications when they are given together: * BIBW 2992 and paclitaxel (Taxol) * BIBW 2992 and paclitaxel and bevacizumab (Avastin) * BIBW 2992 and carboplatin * BIBW 2992 and paclitaxel and carboplatin The effect of the different drug combinations will also be assessed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 17, 2008
Enrollment StartMay 1, 2007
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 17.5 years ago

Interventions

Paclitaxeldrug

Part A and B:80mg/m2 given on Day 1, 8 and 15 of 28 Day cycle.

Carboplatindrug

AUC6 given on day 1 of 21 day cycle

BIBW 2992drug

Escalating dose cohorts

Paclitaxeldrug

Part A and B:80mg/m2 given on Day 1, 8 and 15 of 28 Day cycle.

BIBW2992drug

MTD dose of part A

Paclitaxeldrug

175mg/m2 given on Day 1 of 21 Day cycle

Carboplatindrug

AUC6 given on day 1 of 21 day cycle

Bevacizumabdrug

Escalating dose Cohorts - 5mg / kg, 7.5mg / kg and 10mg / kg given Day 1 and Day 15 of a 28 days cycle

BIBW 2992drug

Escalating dose cohorts

BIBW 2992drug

Escalating dose cohorts