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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01167244

Enrollment

Registered

2010-07-22

Start date

2010-08-31

Completion date

2011-04-30

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small-Cell Lung Carcinoma

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.

Interventions

DRUGBMS-690514

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
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 evaluate safety and tolerability of BMS-690514 in all treated subjects	Average about 10 months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026