Clareo Health | A Two-Stage Phase 1 Dose Escalation Pharmacokinetic Study of Tarceva in Patients With Stage IIIB/IV Non-small Cell Lung Cancer Who Continue to Smoke After Failure of One or Two Prior Chemotherapy Regimens
A Two-Stage Phase 1 Dose Escalation Pharmacokinetic Study of Tarceva in Patients With Stage IIIB/IV Non-small Cell Lung Cancer Who Continue to Smoke After Failure of One or Two Prior Chemotherapy Regimens
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Keep this study
Lead
OSI Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically confirmed diagnosis of stage IIIB/IV NSCLC;
Must have received 1 or 2 prior chemotherapy regimens for advanced NSCLC and now have progressive disease;
Must have recovered from any treatment-related toxicities prior to registration, except for alopecia, grade 1 fatigue, or grade 1 neurotoxicity;
A current cigarette smoker (minimum of 10 cigarettes per day for \>= 1 year and have a positive test for cotinine) despite advice and support to quit;
Age \>= 18 years;
ECOG PS 0-1 and predicted life expectancy \>= 12 weeks;
Previous surgery is permitted provided that wound healing has occurred prior to registration;
Adequate hematopoietic, hepatic and renal function defined as follows: ANC \>= 1.5 x 10\^9/L, platelets \>= 100 x 10\^9/L, bilirubin \<= 1.5 x ULN, ALT \<= 2.5 x ULN (or 5 x ULN in case of liver metastases), creatinine \<= 1.5 x ULN;
No prior treatment with Tarceva or gefitinib (or other drug with significant activity against EGFR (eg, cetuximab and/or ZD6474));
Patients with reproductive potential must practice effective contraceptive measures throughout the study. Women of child-bearing potential must provide a negative pregnancy test within 14 days prior to registration;
Accessible for repeat dosing and follow-up.
You may not be if
Any concurrent anticancer cytostatic or cytotoxic chemotherapy;
Concomitant CYP3A4 or CYP1A2 inducers/inhibitors (or during 14 days prior to study) with the exception of tobacco;
Other active malignancies, unless disease-free and without cancer-specific therapy for at least the last 5 years. Basal or squamous cell skin cancers are not excluded;
Significant history of cardiac disease unless the disease is well-controlled;
Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation in the study;
History of any psychiatric condition that might impair the patient's ability to understand or comply with the requirements; of the study or to provide informed consent.
Gastrointestinal abnormalities, including inability to take oral medication, requirement for IV alimentation, active peptic ulcer or prior surgical procedures affecting absorption;
