Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
Study NCT ID:
NCT00997334
Status:
COMPLETED
Last Update Posted:
2018-02-23
First Post:
2009-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Erlotinib Therapy and Subsequent Development of Mechanisms of Secondary Resistance in Patients With NSCLC
Sponsor:
David M. Jackman, MD
Organization:
Study Overview
Official Title:
First-Line Erlotinib Therapy and the Subsequent Development of Mechanisms of Secondary Resistance in Patients With Non-Small Cell Lung Cancer and Known Sensitizing EGFR Mutations
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
PRIMARY OBJECTIVE
-To prospectively assess the frequency of different genetic mechanisms of secondary resistance in patients' tumors during treatment with erlotinib (e.g., T790M mutations, MET amplification).
* Correlate these genetic changes with patient demographic data and clinical outcomes (time to progression, survival, sites of recurrence/progression).
* Search for novel mechanisms of acquired resistance to erlotinib.
* Identify whether these genetic changes are present at low levels in initial pretreatment tumor specimens.
SECONDARY OBJECTIVE(S)
1. To measure the steady-state plasma concentrations of erlotinib during the course of patients' treatment.
* Determine if the development and/or resolution of skin toxicity is related to plasma erlotinib concentrations.
* Determine if the development of disease progression while on erlotinib is correlated with declines in plasma erlotinib concentrations.
* Assess the plasma levels in patients whose smoking status has been biochemically verified to determine if smoking is associated with lower erlotinib plasma concentration.
2. To analyze from both free plasma DNA and DNA from circulating tumor cells of erlotinib-treated patients for the original sensitizing EGFR mutations and genetic changes associated with secondary resistance.
3. To measure clinical outcomes in patients with known sensitizing mutations in their tumor EGFR when treated with first-line erlotinib.
* Response rate
* Time to progression
* Median overall survival
-To prospectively assess the frequency of different genetic mechanisms of secondary resistance in patients' tumors during treatment with erlotinib (e.g., T790M mutations, MET amplification).
* Correlate these genetic changes with patient demographic data and clinical outcomes (time to progression, survival, sites of recurrence/progression).
* Search for novel mechanisms of acquired resistance to erlotinib.
* Identify whether these genetic changes are present at low levels in initial pretreatment tumor specimens.
SECONDARY OBJECTIVE(S)
1. To measure the steady-state plasma concentrations of erlotinib during the course of patients' treatment.
* Determine if the development and/or resolution of skin toxicity is related to plasma erlotinib concentrations.
* Determine if the development of disease progression while on erlotinib is correlated with declines in plasma erlotinib concentrations.
* Assess the plasma levels in patients whose smoking status has been biochemically verified to determine if smoking is associated with lower erlotinib plasma concentration.
2. To analyze from both free plasma DNA and DNA from circulating tumor cells of erlotinib-treated patients for the original sensitizing EGFR mutations and genetic changes associated with secondary resistance.
3. To measure clinical outcomes in patients with known sensitizing mutations in their tumor EGFR when treated with first-line erlotinib.
* Response rate
* Time to progression
* Median overall survival
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NE_OSI4590s | OTHER | Genentech/Roche | View |