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Trial Exploring Afatinib (BIBW 2992) + Paclitaxel (Part A), Afatinib + Paclitaxel + Bevacizumab (Part B), Afatinib + Carboplatin (Part C) and Afatinib+ Paclitaxel +Carboplatin(Part D) in Patients With Advanced Solid Tumours

NCT00809133 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2016-03-14

Study results available
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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.

Conditions

  • Neoplasms

Interventions

DRUG

Paclitaxel

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

DRUG

Carboplatin

AUC6 given on day 1 of 21 day cycle

DRUG

BIBW 2992

Escalating dose cohorts

DRUG

Paclitaxel

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

DRUG

BIBW2992

MTD dose of part A

DRUG

Paclitaxel

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

DRUG

Carboplatin

AUC6 given on day 1 of 21 day cycle

DRUG

Bevacizumab

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

DRUG

BIBW 2992

Escalating dose cohorts

DRUG

BIBW 2992

Escalating dose cohorts

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00809133 on ClinicalTrials.gov