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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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ClinicalTrials.gov Identifier: NCT00294736
Recruitment Status : Completed
First Posted : February 22, 2006
Last Update Posted : August 8, 2012
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( OSI Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE February 17, 2006
First Posted Date  ICMJE February 22, 2006
Last Update Posted Date August 8, 2012
Study Start Date  ICMJE November 2005
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2009)
To establish the MTD of Tarceva in currently smoking patients with stage IIIB/IV NSCLC. [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00294736 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2009)
To evaluate the survival of currently smoking patients with stage IIIB/IV NSCLC when given Tarceva at the MTD and 150 mg. [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A Two-Stage Phase 1 Dose Escalation Pharmacokinetic Study of Tarceva® (Erlotinib) in Patients With Stage IIIB/IV Non-small Cell Lung Cancer Who Continue To Smoke After Failure of One or Two Prior Chemotherapy Regimens
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE NSCLC
Intervention  ICMJE Drug: Tarceva
Dose Escalation: 150-350+ mg/day
Study Arms
  • Experimental: Arm A
    Arm A (Tarceva MTD established in Part I)
    Intervention: Drug: Tarceva
  • Experimental: Arm B
    Arm B (150 mg Tarceva daily).
    Intervention: Drug: Tarceva
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2011)
57
Original Enrollment  ICMJE
 (submitted: February 17, 2006)
62
Actual Study Completion Date September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00294736
Other Study ID Numbers  ICMJE OSI-774-107
2005-003883-46 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Astellas Pharma Inc ( OSI Pharmaceuticals )
Study Sponsor  ICMJE OSI Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor OSI Pharmaceuticals
PRS Account Astellas Pharma Inc
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP