Erlotinib Therapy and Subsequent Development of Mechanisms of Secondary Resistance in Patients With NSCLC
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- David M. Jackman, MD
- Study ID
- NCT00997334
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Erlotinib — DRUG
Study Details
Erlotinib is a drug which targets non small cell lung cancer with a genetic change (mutation) in the epidermal growth factor receptor (EGFR). This drug has been used in other cancer research studies and information from those studies suggests that Erlotinib can control the growth of these cancer cells.
Key Dates
- First listed
- Oct 19, 2009
- Start date
- Feb 28, 2010
- Status verified
- Jan 2018
- Primary completion
- May 31, 2015
- Completion
- Jan 31, 2017
Study Design
- Enrollment
- 60 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ErlotinibErlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
Primary Outcome Measure
Resistance Mechanism [ Time Frame: Participants were evaluated for incidence of genetic mechanisms of secondary resistance at time of disease progression at which point participants stopped treatment. Progression follow up was up to 3 years in this study cohort. ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | - |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | - |
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