- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00042315
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Vinorelbine as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC)
May 22, 2012 updated by: QLT Inc.
To determine whether tariquidar + first-line single agent vinorelbine chemotherapy in patients with Stage IIIb/IV NSCLC will, with an acceptable safety profile, significantly improve overall survival compared with placebo + vinorelbine.
To compare the effects of tariquidar/vinorelbine with placebo/vinorelbine on tumor response, time to disease progression, performance status, symptom progression, and quality of life in patients with Stage IIIb/IV NSCLC.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment
490
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who have histologically or cytologically proven NSCLC, stage IIIb or stage IV, requiring first-line chemotherapy.
- Patients who have a WHO performance status of 2 and life expectancy of greater than 3 months.
- Patients who are 18 years of age or older and age of consent.
- Patients who are women of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test (serum or urine) at screening, and must be practicing an adequate method of birth control.
- Patients who have neutrophils greater or equal to 1.5 x 103/µL; platelets greater or equal to 100 x 103/µL; bilirubin less or equal to 1.5 times the upper limit of normal or less or equal to 26 µmol/L (1.5 mg/dL); transaminases less or equal to 2.5 times the upper limit of normal or, for patients with known liver metastases, less or equal to 5 times the upper limit of normal; and creatinine equal or less than 141 µmol/L (1.6 mg/dL) or calculated creatinine clearance less or equal to 60 mL/min prior to study treatment.
- Patients who are able to give written informed consent and comply with the protocol.
Exclusion Criteria:
- Patients who are eligible for radiotherapy or surgery for curative intent.
- Patients who have had previous chemotherapy for NSCLC.
- Patients who have a WHO performance status less than 2 or greater than 2.
- Patients with bronchoalveolar carcinoma (an adenocarcinoma in which cylindrical tumor cells grow upon the walls of pre-existing alveoli, from WHO histological typing of lung tumors [66]).
- Patients who have previous or current primary malignancies at other sites within the last 5 years, with the exception of adequately treated cone-biopsied carcinoma of the cervix and basal or squamous cell skin carcinoma.
- Patients who are a poor medical risk because of other nonmalignant systemic diseases or active uncontrolled infections.
- Patients who have symptomatic brain metastases.
- Patients who have other medical or surgical conditions that would contraindicate chemotherapy.
- Patients who have received experimental therapies within the last 4 weeks.
- Patients who have know hypervitaminosis or known sensitivity to ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, d-panthenol, or vitamin E.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Masking: DOUBLE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2002
Primary Completion
June 1, 2003
Study Completion
June 1, 2003
Study Registration Dates
First Submitted
July 26, 2002
First Submitted That Met QC Criteria
July 31, 2002
First Posted (ESTIMATE)
August 1, 2002
Study Record Updates
Last Update Posted (ESTIMATE)
May 23, 2012
Last Update Submitted That Met QC Criteria
May 22, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Vinorelbine
Other Study ID Numbers
- TQD LUNG 002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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