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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Conditions

Non-Small-Cell Lung Carcinoma

Treatments

Drug: BMS-690514

Study type

Interventional

Funder types

Industry

Identifiers

NCT01167244

CA187-020

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No 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