Antineoplastic Agents

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Amino Acids

Afatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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

BIBW 2992 (Afatininb) for patients FISH positive for/or harboring EGFR or HER2 Mutation

BIBW 2992 (Afatinib)

Boehringer Ingelheim

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.

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

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

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).

CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST 1.0 criteria.

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 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.

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 adverse events (AEs) resulting in dose reduction or treatment discontinuation

Patients with AEs by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade

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.

Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.

Afatinib 50mg

Age Continuous

Sex: Female, Male

Due to early study termination, only data on the primary efficacy endpoint were summarized, no CIs were produced and efficacy and safety results were presented for the overall population rather than by tumor category.

Boehringer Ingelheim Call Center

With CB

Without CB

Percentage of Participants With Clinical Benefit (CB)

Trial terminated early, therefore no data summaries produced for time to OR.

Time to Objective Response (OR)

Trial terminated early, therefore no data summaries produced for duration of OR.

Duration of OR

Trial terminated early, therefore no data summaries produced for PFS.

Progression-free Survival (PFS)

With AE leading to drug discontinuation

With AE leading to dose reduction

With Treatment held or paused due to AE

Patients With AEs Resulting in Dose Reduction or Treatment Discontinuation

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Maximum CTCAE Grade

Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication.

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

Trial Identification

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Study Description

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