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Completed

NCT Number: NCT00743938

A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC

The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Bahía Blanca, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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+

Treatment and study plan

BMS-690514

Drug

Tablets, Oral, 200 mg, once daily, Until disease progression or toxicity

Other names: panHER

Erlotinib

Drug

Capsules, Oral, 150 mg, once daily, Until disease progression or toxicity

Other names: Tarceva

Primary outcomes

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

    Time frame: CT/MRI at baseline and every 6 weeks for 36 weeks

Secondary outcomes

  1. To compare the overall survival between BMS-690514 and erlotinib

    Time frame: 15 months

  2. To estimate the overall response rate of BMS-690514 or erlotinib

    Time frame: 15 months

  3. To estimate the tumor size change and PFS rate at 6 weeks

    Time frame: 6 weeks

  4. To assess safety and tolerability of BMS-690514 and erlotinib

    Time frame: 15 months

  5. To estimate the association between efficacy and EGFR copy as measured by FISH for both BMS-690514 and erlotinib

    Time frame: 15 months

  6. To obtain samples for population pharmacokinetics for BMS-690514 in previously treated NSCLC patients

    Time frame: Days 1,8,15, 29

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Aug 29, 2008
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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