Single-arm Trial of BIBW 2992 (Afatinib) in Demographically and Genotypically Selected NSCLC Patients

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: BIBW2992; Drug: BIBW2992 + paclitaxel

• Registration Number: NCT00730925
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the RECIST criteria, in patients with advanced NSCLC Stage IIIB or IV whose tumours harbour activating mutations within exon 18 to exon 21 of the EGFR receptor, in patients with mutations in the HER2/neu receptor and in patients with EGFR FISH positive tumours with no EGFR mutations.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-30
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Primary Completion: 2012-01
• Results First Submitted: 2013-08-09
• Results First Submitted QC: 2013-08-09
• Results First Posted: 2013-10-23
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BIBW 2992	BIBW2992	patient to receive tablets of BIBW 2992 once a day, starting at high dose until progression of the disease
BIBW 2992 + paclitaxel	BIBW2992 + paclitaxel	patient whose disease progressed on treatment with BIBW 2992 monotherapy to receive tablet of BIBW 2992 once a day in combination with i.v. paclitaxel 3 weekly

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Best Objective Response	Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.	Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) Time	Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.	PFS time defined as time from the start of treatment to the earliest of progression (RECIST), clinical progression (investigator), start of new anti-cancer treatment or death.
Summary of Pre-dose Concentrations of Afatnib in Plasma	Day 15, 29 and 57	Pre-dose Concentrations of Afatinib in Plasma at Steady State on Days 15, 29 and 57 (Cpre,ss,15, Cpre,ss,29 and Cpre,ss,57)
Percentage of Participants With Disease Control (DC)	Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.	Percentage of participants with OR or stable disease (SD) as determined by RECIST version 1.0.

Trial Locations

Locations (7)

1200.41.32003 Boehringer Ingelheim Investigational Site; 🇧🇪 Antwerpen, Belgium

1200.41.32006 Boehringer Ingelheim Investigational Site; 🇧🇪 Namur, Belgium

1200.41.32007 Boehringer Ingelheim Investigational Site; 🇧🇪 Charleroi, Belgium

1200.41.32011 Boehringer Ingelheim Investigational Site; 🇧🇪 Leuven, Belgium

1200.41.32001 Boehringer Ingelheim Investigational Site; 🇧🇪 Jette, Belgium

1200.41.32008 Boehringer Ingelheim Investigational Site; 🇧🇪 Liège, Belgium

1200.41.34001 Boehringer Ingelheim Investigational Site; 🇪🇸 Badalona (Barcelona), Spain