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Phase 2 Trial of BMS-690514 in Non-Small Cell Lung Cancer Subjects Who Have Been Treated With Gefitinib or Erlotinib and Are Genotypically EGFR Mutation Positive or Who Have Had a Prior Response


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small-Cell Lung Carcinoma

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Trial Information

Phase 2 Trial of BMS-690514 in Non-Small Cell Lung Cancer Subjects Who Have Been Treated With Gefitinib or Erlotinib and Are Genotypically EGFR Mutation Positive or Who Have Had a Prior Response


Inclusion Criteria:



- Recurrent, metastatic or progressive NSCLC without any indication of radiotherapy.
Subjects must have:

- Pathologically confirmed NSCLC

- Previously received treatment with single agent Gefitinib or Erlotinib and completed
treatment at least 2 weeks prior to study entry

- Any one of the following:

- A tumor that harbors an EGFR mutation

- Objective clinical benefit from treatment with Gefitinib or Erlotinib as defined by
either documented and confirmed partial or complete response (RECIST or WHO), or
significant and durable (≥ 6 months) clinical benefit (stable disease as defined by
RECIST or WHO) Progression of NSCLC while on continuous treatment with gefitinib or
erlotinib as noted by CT/MRI increase in disease after having a confirmed partial or
complete response or evidence of ≥ 6 months of SD within 3 months of study enrollment

Exclusion Criteria:

- Symptomatic brain metastasis

- History of TIA, CVA, or thrombotic/thromboembolic event (within last 6 months)

- History of hemoptysis greater than 10 mL/day within last 30 days

- Uncontrolled or significant cardiovascular disease

- History of uncontrolled diarrhea, Crohn's disease or ulcerative colitis

- Inability to swallow tablets, untreated malabsorption or GI surgery that results in
inability to absorb protocol therapy

- Women unwilling to avoid pregnancy or use adequate contraception

- History of allergy or adverse drug reaction to gefitinib or erlotinib

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate objective response rate in NSCLC subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR mutation positive or who have had a prior a response

Outcome Time Frame:

Tumor assessment Day 29 and every 8 weeks from Day 1 thereafter until disease progression

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

CA187-020

NCT ID:

NCT01167244

Start Date:

August 2010

Completion Date:

April 2011

Related Keywords:

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

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