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A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients


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

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Trial Information

A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients


Inclusion Criteria:



- ECOG PS of 0 or 1

- Histologically confirmed NSCLC

- Adequate amount of tumor (archived or fresh) for biomarker evaluation

- Received one to two regimens of chemotherapy (with at least one platinum-containing)

- Serum creatinine of less than 1.0 mg/dL or a 24 hour creatinine clearance of greater
than 60 mL/min

- Stable control of blood pressure on agents other than calcium channel blockers

- Women of child-bearing potential must avoid pregnancy or maintain adequate
contraception

- Must be able to swallow pills and take the medications at the same time every day on
an empty stomach

Exclusion Criteria:

- ECOG PS 2 or greater

- Women unwilling to avoid pregnancy or use adequate contraception

- Symptomatic brain metastases

- Recent history of TIA, CVA, or thrombotic/thromboembolic event (within 6 months)

- History of hemoptysis greater than 10 mL/day

- Significant cardiovascular disease

- Uncontrolled diarrhea, Crohn's disease, ulcerative colitis, or any malabsorptive
disease

- History of use of other TKIs

- Uncontrolled hypertension

- HIV+

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To compare the progression-free survival of patients on BMS-690514 with those on erlotinib

Outcome Time Frame:

CT/MRI at baseline and every 6 weeks for 36 weeks

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA187-017

NCT ID:

NCT00743938

Start Date:

March 2009

Completion Date:

June 2012

Related Keywords:

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

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Henry Ford HospitalDetroit, Michigan  48202
Hematology Oncology, P.C.Stamford, Connecticut  06902
Oregon Health & Science UniversityPortland, Oregon  97201
Yale University School Of MedicineNew Haven, Connecticut  06520
Cancer Center of the CarolinasGreenville, South Carolina  29615
Mass General HospitalBoston, Massachusetts  02114
Piedmont Hematology Oncology Associates, PLLCWinston-Salem, North Carolina  
Hema/Oncology Assoc. Of NepaDunmore, Pennsylvania  18512