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A Phase 1b, Multicenter Trial to Evaluate Molecular Determinants of Response to Erlotinib and MK0646 in Advanced Non-Small-Cell Lung Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-small Cell Lung

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Trial Information

A Phase 1b, Multicenter Trial to Evaluate Molecular Determinants of Response to Erlotinib and MK0646 in Advanced Non-Small-Cell Lung Cancer


Inclusion Criteria:



- Patient has locally advanced or metastatic stage IIIB/IV Non-small cell lung cancer

- Patient has measurable disease

- Patient has accessible tumor and consents to undergo a tumor biopsy [Part II only]

- Patient is 18 years of age or older

- Patient has a performance status of 0-2 on ECOG scale

- Women of childbearing potential have a negative pregnancy test

- Patients in Part I must: 1. be a female non-smoker with non-squamous histology who
has had one or two prior systemic chemotherapies or 2. have documented EGFR mutation
or EGFR gene amplification, regardless of demographic or clinical characteristics,
who have had no more than two prior systemic chemotherapies.

- Patients in Part II must have had one or two chemotherapy regimens for recurrent or
metastatic disease

Exclusion Criteria:

- Patient has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab)
within 4 weeks

- Patient has not recovered from adverse events from previous therapy within 4 weeks

- Patient has received EGFR-TKI inhibitor/anti-EGFR mAb therapy

- Patient has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy

- Patient has untreated brain metastases

- Patient has had radiotherapy to a field that affects the chest or abdomen, or
thoracic surgery within 3 months prior to entering the study

- Patient is taking part in another clinical study

- Patient abuses drugs or alcohol

- Patient is pregnant or breastfeeding

- Subject is HIV positive

- Patient has active hepatitis

- Patient is using growth hormone or growth hormone inhibitors

- Patient has poorly controlled diabetes mellitus

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Validate imaging platform and molecular markers

Outcome Time Frame:

FDG response at Weeks 1 and 3 following chemotherapy

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

2008_518

NCT ID:

NCT00729742

Start Date:

February 2009

Completion Date:

May 2011

Related Keywords:

  • Carcinoma, Non-Small Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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