Understanding Mechanisms of Acquired Resistance to BIBW2992
- Participants will take tables 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 woll 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 fo
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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the proportion of patients that have a T790M mutation on their progression biopsy and to compare this with published data for first-generation EGFR tyrosine kinase inhibitors.
Lecia V. Sequist, MD, PhD
Massachusetts General Hospital
United States: Food and Drug Administration
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|