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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01167244
Other study ID # CA187-020
Secondary ID
Status Completed
Phase Phase 2
First received July 16, 2010
Last updated September 23, 2015
Start date August 2010
Est. completion date April 2011

Study information

Verified date September 2015
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices AgencyKorea: Food and Drug AdministrationTaiwan: Department of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
BMS-690514
Tablets, Oral, 200 mg, once daily, until disease progression or toxicity

Locations

Country Name City State
Japan Local Institution Kashiwa-Shi Chiba
Japan Local Institution Koto-Ku Tokyo
Japan Local Institution Osaka-Sayama-Shi Osaka
Japan Local Institution Sunto-Gun Shizuoka

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary 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 No
Secondary 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 No
Secondary To estimate disease control rate and progression free survival in all treated subjects Tumor assessment from Day 29 No
Secondary To estimate disease control rate and progression free survival in all treated subjects Tumor assessment every 8 weeks from Day 1 until disease progression No
Secondary To evaluate safety and tolerability of BMS-690514 in all treated subjects Average about 10 months Yes
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