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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( OSI Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00294736
First received: February 17, 2006
Last updated: August 6, 2012
Last verified: August 2012

February 17, 2006
August 6, 2012
November 2005
September 2007   (final data collection date for primary outcome measure)
To establish the MTD of Tarceva in currently smoking patients with stage IIIB/IV NSCLC. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00294736 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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® (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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
NSCLC
Drug: Tarceva
Dose Escalation: 150-350+ mg/day
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
September 2007
September 2007   (final data collection date for primary outcome measure)

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;
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00294736
OSI-774-107, 2005-003883-46
Yes
Astellas Pharma Inc ( OSI Pharmaceuticals )
OSI Pharmaceuticals
Not Provided
Study Director: Medical Monitor OSI Pharmaceuticals
Astellas Pharma Inc
August 2012

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