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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00294736
Other study ID # OSI-774-107
Secondary ID 2005-003883-46
Status Completed
Phase Phase 1
First received February 17, 2006
Last updated August 6, 2012
Start date November 2005
Est. completion date September 2007

Study information

Verified date August 2012
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a multicenter, open-label, randomized phase 1 study of escalating doses of Tarceva in patients with advanced NSCLC who currently smoke.

Part I will establish the maximum tolerated dose (MTD) of Tarceva in current smokers.

In Part II, patients will be randomized 1:1 to two treatment groups: Arm A (Tarceva MTD established in Part I) and Arm B (150 mg Tarceva daily). Patients in both arms will be treated for two weeks and then have pharmacokinetic samples collected on day 14. Part II is open as of Nov-2006.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date September 2007
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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;

- Clinically significant ophthalmologic abnormalities;

- Pregnant or breast-feeding females. Males or females not practicing effective birth control;

- Symptomatic brain metastases which are not stable, require steroids, or that have required radiation within the last 28 days;

- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Tarceva
Dose Escalation: 150-350+ mg/day

Locations

Country Name City State
United Kingdom Aberdeen Royal Infirmary Aberdeen
United Kingdom Ninewells Hospital Dundee
United Kingdom University of Edinburgh,Division of Oncology, Edinburgh Scotland
United Kingdom Beatson West of Scotland Cancer Centre Glasgow
United Kingdom Sir Bobby Robson Cancer Trials Research Centre Newcastle upon Tyne
United Kingdom Department of Oncology Sheffield
United Kingdom Royal Marsden Hospital Sutton
United States Comprehensive Blood and Cancer Center Bakersfield California
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
OSI Pharmaceuticals

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary To establish the MTD of Tarceva in currently smoking patients with stage IIIB/IV NSCLC. 2 years No
Secondary To evaluate the survival of currently smoking patients with stage IIIB/IV NSCLC when given Tarceva at the MTD and 150 mg. 2 years Yes
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