A Double-Blind, Randomized, Parallel, Two-Arm Phase II Trial of BMS-690514 versus Erlotinib in Previously Chemotherapy Treated Non-Small Cell Lung Cancer PatientsRevised Protocol Number 02, incorporating amendments 03 and 04
- Conditions
- Progressive or recurrent non-small cell lung cancer (NSCLC) after treatment with one to two lines of cytotoxic chemotherapyMedDRA version: 9.1Level: LLTClassification code 10061873Term: Non-small cell lung cancer
- Registration Number
- EUCTR2008-004691-44-FR
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 188
1) Signed Written Informed Consent
2) Target Population
a) Able to comply with visits/procedures required by protocol.
b) ECOG performance status 0 or 1. See Protocol Appendix 7.
c) Life expectancy at least 3 months.
d) Confirmed NSCLC by histologic or cytologic methods and radiographic proof of disease.
e) Adequate amount of tumor sample (archival or fresh) must be available for molecular biomarker evaluation and adequacy confirmed by local pathologist review. See Protocol Appendix 9.
f) Received one or two chemotherapy regimens (none given as adjuvant treatment) with progression or recurrent disease (at least one of these platinum containing).
g) Patients must have ended their prior chemotherapy for at least 4 weeks prior to study entry. Patients must have completed therapy with bevacizumab or cetuximab at least 4 weeks prior to study entry.
h) Patients who received radiotherapy must have completed treatment at least 2 weeks prior to study entry.
i) Adequate bone marrow function defined as:
? Absolute neutrophil count > 1500/mm³.
? Hemoglobin > 10 g/dL (The use of erythropoietin stimulating agents is permitted.)
? Platelet count > 100,000/mm³.
j) Adequate renal parameters defined as:
? Blood urea nitrogen of < 30 mg/dL.
? Serum creatinine of < 1.0 mg/dL or 24 hour creatinine clearance > 60 mL/minute. For patients older than 70 years of age a 24 hour urine collection must indicate a creatinine clearance of > 60 mL/minute.
? Serum magnesium between 1.5 and 2.5 mg/dL (supplementation to achieve this range is acceptable).
? Serum potassium between 3.5 and 5.0 mEq/L (supplementation to achieve this range is acceptable).
k) Adequate hepatic parameters defined as:
? AST = 2.5 times the institutional ULN.
? ALT = 2.5 times the institutional ULN.
? Alkaline phosphatase = 2 times the institutional ULN.
? Total bilirubin = 2 times the institutional. ULN
l) In the presence of documented liver metastases, the hepatic parameters will be defined as:
? AST = 3.5 times the institutional ULN.
? ALT = 3.5 times the institutional ULN.
? Alkaline phosphatase = 2.5 times the institutional ULN.
? Total bilirubin = 2 times the institutional ULN.
m) not applicable (see Protocol Amendment 4)
n) Stable control of blood pressure with a systolic blood pressure consistently below 150 mmHg and a diastolic blood pressure consistently below 90 mmHg on antihypertensives. Subjects with a history of hypertension who are receiving treatment with calcium channel blockers that are CYP3A4 substrates must be changed to an alternative antihypertensive medication and be stable on the new medication for at least 4 weeks before study entry.
o) Brain metastases that have remained stable in size on CT or MRI, have not progressed for 4 weeks, and have no evidence of neurologic impairment.
3) Age and Sex
a) Men and women, age =18 years.
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1) Sex and Reproductive Status
a) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational product.
b) Women who are pregnant or breastfeeding.
c) Women with a positive pregnancy test on enrollment or prior to investigational product administration.
d) Sexually active fertile men not using effective birth control if their partners are WOCBP (including up to 12 weeks after the last dose of investigational product).
2) Target Disease Exceptions
a) Patients with symptomatic brain metastases.
b) Patients with signs or symptoms suggestive of spinal cord compression.
c) Patients with signs or symptoms suggestive of intractable back pain due to compressive or destructive mass.
d) Any condition that requires emergent treatment using steroids and/or radiation therapy or emergent surgery.
e) Patients who have central pulmonary tumor close to large vessels.
3) Medical History and Concurrent Diseases
a) ECOG performance status of = 2.
b) History of transient ischemic accident, cerebrovascular accident, thrombotic or thromboembolic event (pulmonary embolus or deep venous thrombosis) within the last 6 months.
c) Patients with previous malignancies (except non-melanoma skin cancers, in situ bladder or cervical cancers/dysplasia) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.
d) Patients with history of hemoptysis greater than 10 mL/day within the last 30 days.
e) Uncontrolled or significant cardiovascular disease including:
? Myocardial infarction within 6 months.
? Uncontrolled angina within 6 months.
? Class III-IV New York Heart Association (NYHA) congestive heart failure
? Uncontrolled hypertension (Systolic BP > 150 or diastolic BP > 90 mmHg for 24 hours) despite optimized anti-hypertensive therapy. BP must be below 150/90 mmHg at screening. Subjects with a history of hypertension who are receiving treatment with calcium channel blockers that are CYP3A4 substrates should be changed to an alternative antihypertensive medication and be stable on the new medication for at least 4 weeks before study entry.
f) Any history of uncontrolled diarrhea, Crohn’s disease or ulcerative colitis that may be exacerbated by the use of EGFR TKIs.
g) A serious uncontrolled medical disorder or active infection which would impair the ability of the subject to receive protocol therapy or whose control may be jeopardized by the complications of this therapy.
h) Any psychiatric or other disorders such as dementia that would prohibit the subjects from understanding or rendering informed consent or from fully complying with protocol treatment and follow-up.
i) Inability to swallow tablets, untreated malabsorption syndrome or gastrointestinal surgery that results in inability to properly absorb protocol therapy.
j) Any surgery within 4 weeks of study enrollment.
k) Patients who are HIV+.
l) Inability to tolerate multiple blood sampling/or tolerate venous access.
m) Any other medical, psychiatric, and/or social reason as determined by the Investigator.
4) Physical and Laboratory Test Findings
a) Absolute neutrophil counts < 1500/mm³, platelet count < 100,000/mm³, or hemoglobin < 10 g/dL.
b) Serum total bilirubin > 2 times the institutional upper limits of normal or ALT or AST > 2.5 times the institutional upper limits of no
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method