Understanding Mechanisms of Acquired Resistance to BIBW2992
|ClinicalTrials.gov Identifier: NCT01074177|
Recruitment Status : Completed
First Posted : February 24, 2010
Results First Posted : March 9, 2018
Last Update Posted : March 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer EGFR Mutations||Drug: BIBW 2992||Not Applicable|
- Participants will take tablets of BIBW 2992 once a day during each cycle. Each cycle is 28 days (4 weeks).
- Participants will come to the clinic on Day 1, 8 and 15 of Cycle 1. For Cycle 2 through 8, they will need to come to the clinic on Day 1. After Cycle 8, they will have study visits every 2 months.
- The following tests and procedures will be performed at these clinic visits: physical examination, routine blood tests, research blood samples, EKG (every fourth cycle starting cycle 5), ECHO or MUGA (every fourth cycle starting cycle 5), an assessment of the tumor by CT or MRI scan (every 8 weeks).
- Participants may continue to participate in this research study as long as their tumor does not grow and their disease does not worsen and they do not have any severe side effects.
- Participants will have a tumor biopsy performed at the end of their participation in this study if their tumor is growing or if they have a new tumor. The purpose of this biopsy is to assess for the presence or the absence of the mutation T790M.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Understanding Mechanisms of Acquired Resistance to BIBW2992|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
Experimental: BIBW 2992
BIBW 2992 Taken orally once a day
Drug: BIBW 2992
Taken orally once a day
Other Name: Afatinib
- Number of Participants That Have a T790M Mutation on Their Progression Biopsy. [ Time Frame: At the time of disease progression (median duration of 11.4 months from start of treatment) ]
- Response Rate [ Time Frame: Baseline and then after the end of every two 28 day cycles until treatment is discontinued; median duration of followup of 19.3 months ]
The number of participants with either a complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- CR: Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm
- PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
- Median Progression-free and Overall Survival [ Time Frame: start of treatment, at the time of disease progression, time of death ]The progression-free and overall survival times. Overall survival is measured from the start of treatment until the time of death or until the participant is lost to follow-up. Progression free survival is measured from the start of treatment until the time of progression, death, or until the participant is lost to follow-up (whichever occurs first). Progression is defined as having at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions denotes disease progression.
- Number of Participants With Biopsy Complications From Repeat Tumor Biopsies [ Time Frame: 7 days post biopsy and ≥ 30 days post-biopsy ]The number of participants with biopsy complications from repeat tumor biopsies taken following disease progression. Biopsy complications are any adverse events considered to be potentially related to the biopsy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074177
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Lecia V. Sequist, MD, PhD||Massachusetts General Hospital|