Skip to main content
OpenTrials
Completed

NCT Number: NCT01167244

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

The purpose of this study is to observe an improvement in overall 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-Small-Cell Lung Carcinoma 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, Kashiwa-Shi, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

BMS-690514

Drug

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

Primary outcomes

  1. 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

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

  2. 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

    Time frame: Tumor assesments on Day 29 by CT or MRI

  3. 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

    Time frame: Tumor assessments every 8 weeks from Day 1 by CT or MRI

Secondary outcomes

  1. To estimate disease control rate and progression free survival in all treated subjects

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

  2. To estimate disease control rate and progression free survival in all treated subjects

    Time frame: Tumor assessment from Day 29

  3. To estimate disease control rate and progression free survival in all treated subjects

    Time frame: Tumor assessment every 8 weeks from Day 1 until disease progression

  4. To evaluate safety and tolerability of BMS-690514 in all treated subjects

    Time frame: Average about 10 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 22, 2010
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.