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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01167244
First received: July 16, 2010
Last updated: July 18, 2011
Last verified: July 2011

July 16, 2010
July 18, 2011
August 2010
April 2011   (final data collection date for primary 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 [ Time Frame: Tumor assessment Day 29 and every 8 weeks from Day 1 thereafter until disease progression ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01167244 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • To estimate disease control rate and progression free survival in all treated subjects [ Time Frame: Tumor assessment from Day 29 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate safety and tolerability of BMS-690514 in all treated subjects [ Time Frame: Average about 10 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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 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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small-Cell Lung Carcinoma
Drug: BMS-690514
Tablets, Oral, 200 mg, once daily, until disease progression or toxicity
Experimental: BMS-690514
Intervention: Drug: BMS-690514
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01167244
CA187-020
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP