A Phase II Trial of Afatinib(BIBW 2992) in Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type Epidermal Growth Factor Receptor[EGFR]
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01003899
First received: October 28, 2009
Last updated: April 13, 2012
Last verified: April 2012
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Purpose
To explore the efficacy of BIBW 2992 defined by the objective response rate (Complete Response, Partial Response) as determined by Response Evaluation Criteria in Solid Tumours[RECIST] 1.1 in the patients with advanced (stage IIIB or IV) adenocarcinoma of the lung harbouring wild-type EGFR.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung |
Drug: afatinib (BIBW 2992) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of BIBW 2992 as a Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type EGFR |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- The primary endpoint is the objective tumour response rate (complete response, partial response) as determined by Response Evaluation Criteria in Solid Tumours version 1.1. [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Disease control (complete response, partial response, stable disease) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
- Safety as indicated by intensity and incidence of adverse events according to United State National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
- Exploratory biomarkers: amphiregulin, c met amplification, Kirsten rat sarcoma viral oncogene homolog(KRAS) mutation, Phospho-Insulin Like Growth Factor Receptor and Phosphatase and Tensin homolog [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 43 |
| Study Start Date: | October 2009 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: afatinib (BIBW 2992)
patient to receive afatinib(BIBW 2992) po QD in an open-label manner
|
Drug: afatinib (BIBW 2992)
afatinib (BIBW 2992) po QD
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Pathologically confirmed stage IIIB/IV adenocarcinoma in non-small cell lung cancer[NSCLC]
- Progressive disease following a second-line cytotoxic chemotherapy including at least one platinum-containing regimen
- A known wild-type EGFR status
- Patients 18 years of age or older
Exclusion criteria:
- More than two prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic disease
- Prior treatment with EGFR targeting small molecules or antibodies
- Radiotherapy or surgery within 4 weeks prior to study entry
- Active brain metastasis
- Known pre-existing interstitial lung disease
- History or presence of clinically relevant cardiovascular abnormalities
- Cardiac left ventricular function with resting ejection fraction of less than 50%
- Absolute neutrophil count[ANC] < 1,500/mm3
- Platelet count <100,000/mm3
- Creatinine clearance<60ml/min or serum creatinine >1.5 times upper limit of normal
- Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial
- Pregnancy or breast-feeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01003899
Locations
| Korea, Republic of | |
| 1200.72.8203 Boehringer Ingelheim Investigational Site | |
| Seoul, Korea, Republic of | |
| 1200.72.8202 Boehringer Ingelheim Investigational Site | |
| Seoul, Korea, Republic of | |
| 1200.72.8201 Boehringer Ingelheim Investigational Site | |
| Seoul, Korea, Republic of | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01003899 History of Changes |
| Other Study ID Numbers: | 1200.72 |
| Study First Received: | October 28, 2009 |
| Last Updated: | April 13, 2012 |
| Health Authority: | Korea, Republic of: Korea Food and Drug Administration |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Cystic, Mucinous, and Serous Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013