Phase II Trial of BIBW 2992 (Afatinib) in Genetically Pre-screened Cancers With EGFR and/or HER2 Gene Amplification.

Phase 2

Terminated

• Conditions: Neoplasms
• Interventions: Drug: BIBW 2992 (Afatinib)

• Registration Number: NCT00748709
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This is a Phase II open-label exploratory trial of BIBW 2992 administered to patients with tumors of various histologies found to possess EGFR and/or HER2 gene amplification, or EGFR activating mutations.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-09-08
• Study First Submitted QC: 2008-09-08
• Study First Posted: 2008-09-09
• Study Start: 2008-10
• Primary Completion: 2010-11
• Results First Submitted: 2013-08-08
• Results First Submitted QC: 2013-08-08
• Results First Posted: 2013-10-14
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-05
• Last Update Posted: 2013-11-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BIBW 2992 (Afatinib)	BIBW 2992 (Afatinib)	BIBW 2992 (Afatinib) for patients FISH positive for/or harboring EGFR or HER2 Mutation

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Objective Response (OR)	Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks thereafter	OR is defined as the percentage of patients with complete response (CR) or partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST 1.0).

Secondary Outcome Measures

Name	Time	Method
Time to Objective Response (OR)	Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock	The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.
Duration of OR	Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock.	Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.
Percentage of Participants With Clinical Benefit (CB)	Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock	CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST 1.0 criteria.
Progression-free Survival (PFS)	Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock.	PFS was defined as the time from the start of treatment to the occurrence of disease progression or death, whichever came first. Disease progression was assessed according to RECIST 1.0 criteria as well as by the investigators assessment, progression date recorded from post trial follow up or start of new anticancer treatment.
Patients With AEs Resulting in Dose Reduction or Treatment Discontinuation	First administration of trial medication until 28 days after last administration of trial medication	Patients with adverse events (AEs) resulting in dose reduction or treatment discontinuation
Maximum CTCAE Grade	First administration of trial medication until 28 days after last administration of trial medication	Patients with AEs by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade
Number of Patients With Diarrhea or Rash	First administration of trial medication until 28 days after last administration of trial medication	Number of Patients with Diarrhea or Rash
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15) for Patients on 50mg on Day 15	Day 15	Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15 for patients on 50mg on day 15.

Trial Locations

Locations (15)

1200.26.12 Boehringer Ingelheim Investigational Site; 🇺🇸 Dallas, Texas, United States

1200.26.11 Boehringer Ingelheim Investigational Site; 🇺🇸 Denver, Colorado, United States

1200.26.2 Boehringer Ingelheim Investigational Site; 🇺🇸 New York, New York, United States

1200.26.3 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

1200.26.4 Boehringer Ingelheim Investigational Site; 🇺🇸 Albany, New York, United States

1200.26.8 Boehringer Ingelheim Investigational Site; 🇺🇸 Tyler, Texas, United States

1200.26.10 Boehringer Ingelheim Investigational Site; 🇺🇸 Vancouver, Washington, United States

1200.26.88601 Boehringer Ingelheim Investigational Site; 🇨🇳 Taipei, Taiwan

1200.26.88603 Boehringer Ingelheim Investigational Site; 🇨🇳 Tainan, Taiwan

1200.26.88602 Boehringer Ingelheim Investigational Site; 🇨🇳 Tao-Yuan, Taiwan

1200.26.9 Boehringer Ingelheim Investigational Site; 🇺🇸 Indianapolis, Indiana, United States

1200.26.7 Boehringer Ingelheim Investigational Site; 🇺🇸 Kettering, Ohio, United States

1200.26.1 Boehringer Ingelheim Investigational Site; 🇺🇸 Boston, Massachusetts, United States

1200.26.6 Boehringer Ingelheim Investigational Site; 🇺🇸 Norfolk, Virginia, United States

1200.26.13 Boehringer Ingelheim Investigational Site; 🇺🇸 Las Vegas, Nevada, United States