Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Afatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

BIBW 2992 in EGFR FISH positive NSCLC patients

BiBW 2992

Boehringer Ingelheim

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 EGFR FISH positive advanced NSCLC Stage IIIB or IV, selected according to the following scheme:

* Forty (40) 1st line patients
* Thirty (30) 2nd line patients Patients entered into the trial will be treated and followed until death or lost to follow-up. Additional information will be obtained on the safety profile and PK analysis of BIBW 2992.

BIBW2992 (Afatinib) in Advanced (EGFR-FISH +) NSCLC (Non Small Cell Lung Cancer) Patients

A Phase II Single-arm Trial of BIBW 2992 in EGFR FISH Positive Non-small Cell Lung Cancer Patients

Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.

Cumulative number of participants with objective response by time points with responders.

Duration of confirmed Objective Response is measured from the time of first Objective Response (OR) to the time of progression or death (or date of censoring for progression free survival).

Percentage of participants with Objective response (OR) or stable disease (SD) as determined by RECIST version 1.0.

Duration of Disease Control is measured from the time of first Objective Response to the time of progression or death (or date of censoring for progression free survival) or respectively for SD as the time from date of randomization to date that disease progression.

Progression Free Survival 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.

Overall survival time is defined as time from the date of start of treatment to the date of death.

Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15.

The safety of patients was overall assessed in terms of adverse events (AEs), graded according to US NCI CTCAE version 3.0 \[R04-0474\], including skin reactions and gastrointestinal AEs.

Number of participants with clinical relevant findings in Laboratory safety parameters, vital signs and Left ventricular ejection fraction . Relevant findings or worsenings of baseline conditions were reported as Adverse Events.

There were no clinically relevant finding reported for Vital signs and Left ventricular ejection fraction (LVEF).

Performance status assessed according to Eastern Cooperative Oncology Group (ECOG) performance status based on categories defined below :

0 : Fully active, able to carry on all pre-disease performance without restriction.

1. : Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
2. : Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.
3. : Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours.
4. : Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
5. : Dead.

Note: The ECOG scores presented are assessed at the end of treatment not at baseline, hence the patients having ECOGs\>2 are included.

Afatinib 50mg film coated tablets where administered once daily as long as they were tolerated by patients, until a disease progression (according to the response evaluation criteria in solid tumors)

Afatinib 50mg

Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)

Age, Continuous

Sex: Female, Male

Boehringer Ingelheim Call Center

Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.

Percentage of Participants With Best Objective Response

by week 8

by week 96

Number of Participants With Objective Response (OR) Categorized by Time

Duration of Confirmed Objective Response (OR)

Percentage of Participants With Disease Control (DC)

Duration of Confirmed Disease Control

Progression Free Survival (PFS) Time

Overall Survival (OS) Time

Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 1st line anti cancer treatment, indicating that they had not received prior treatment with chemotherapy.

Afatinib 50mg 1st Line

Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 2nd line anti cancer treatment, indicating that they had received one prior anti cancer treatment with chemotherapy.

Afatinib 50mg 2nd Line

Pharmacokinetic set (PK set) contains all patients who received study medication and have evaluable pharmacokinetic parameter data.

Data from patients who received the starting dose of 50 mg afatinib and were still on treatment and not dose-reduced on Day 15 are presented.

Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15)

Diarrhoea

Stomatitis

Nausea

Vomiting

Constipation

Abdominal pain

Abdominal pain upper

Cheilitis

Dyspepsia

Dysphagia

Abdominal distension

Dry mouth

Flatulence

Gastritis erosive

Odynophagia

Peritoneal haemorrhage

Rectal haemorrahage

Tongue Ulceration

Rash

Skin exfoliation

Dry skin

Nail disorder

Pruritus

Dermatitis acneiform

Alopecia

Granuloma skin

Hirsutism

Hypertrichosis

Nail discolouration

Night sweats

palmar-plantar erythrodysaesthesia syndrome

Skin fissures

Skin reaction

Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder

Alanine aminotransferase increased

Aspartate aminotransferase increased

Blood alkaline phosphatase increased

Blood bilirubin increased

Blood Creatine phosphokinase increased

Blood lactate dehydrogenase increased

Ejection fraction decreased

Gamma-glutamyltransferase increased

International normalised ratio increased

Transaminases increased

Weight decreased

Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction

Missing

Assessment of Eastern Cooperative Oncology Group (ECOG) Performance Status

Overall Study

Spots Global Cancer Trial Database for BIBW2992 (Afatinib) in Advanced (EGFR-FISH +) NSCLC (Non Small Cell Lung Cancer) Patients

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial