NCT01167244

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2010

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

October 12, 2015

Status Verified

September 1, 2015

Enrollment Period

8 months

First QC Date

July 16, 2010

Last Update Submit

September 23, 2015

Conditions

Non-Small-Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (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

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

  • 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

    Tumor assesments on Day 29 by CT or MRI

  • 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

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

Secondary Outcomes (4)

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

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

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

    Tumor assessment from Day 29

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

    Tumor assessment every 8 weeks from Day 1 until disease progression

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

    Average about 10 months

Study Arms (1)

BMS-690514

EXPERIMENTAL
Drug: BMS-690514

Interventions

BMS-690514DRUG

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

BMS-690514

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Local Institution

Kashiwa-Shi, Chiba, 2778577, Japan

Location

Local Institution

Osaka-Sayama-Shi, Osaka, 5898511, Japan

Location

Local Institution

Sunto-Gun, Shizuoka, 4118777, Japan

Location

Local Institution

Koto-Ku, Tokyo, 1358550, Japan

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

BMS-690514

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 16, 2010

First Posted

July 22, 2010

Study Start

August 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

October 12, 2015

Record last verified: 2015-09

Locations

JP(4)