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Phase 1 Study of TG01 and Erlotinib in Non-small Cell Lung Cancer (NCSLC) Patients

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ClinicalTrials.gov Identifier: NCT00569114
Recruitment Status : Completed
First Posted : December 6, 2007
Last Update Posted : March 17, 2010
Sponsor:
Information provided by:
Tragara Pharmaceuticals, Inc.

Brief Summary:
This is a multicenter, open-label, phase 1, dose escalation study. The purpose is to determine the highest dose of TG01 that can be safely given to patients with Non-Small Cell Lung Cancer in combination with erlotinib.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: TG01 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Phase 1 Dose-Escalation Pharmacokinetic and Pharmacodynamic Study of TG01 Tablets in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients
Study Start Date : October 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
1 Drug: TG01
Drug:TG01tablets given orally QD Drug: erlotinib tablets 150mg QD



Primary Outcome Measures :
  1. Saftey, maximum tolerated dose, optimal biological dose and pharmacokinetics. [ Time Frame: Baseline, 8, 15 and 28 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (include but are not limited to):

  • Histogically or pathologically determined relapsed/recurrent Stage IIIb (plueral effusion) or IV NSCLC.
  • Measurable or evaluable disease as defined by RECIST
  • Must have failed at least one prior chemotherapy regimen or have refused chemotherapy.
  • ECOG perfromance status of 0,1, or 2.

Exclusion Criteria (include but are not limited to):

  • Radiation therapy (excluding CNS therapy) < 2 weeks, chemotherapy, non-cytotoxic investigational agents or high dose corticosteroids within 3 weeks of intitating therpy or patients who have not recovered from adverse effects due to agents administered more than 3 weeks earlier.
  • Evidence of New York Heart Associatation Class III or greater cardiac disease.
  • History of myocardial infarction, stroke, or cardiovascular intervention within the last 12 months.
  • Patients on anti-platlet drugs or anticoagulants such as Placix and Coumadin.
  • Systemic central nervous system metastases. The patient must be stable after radiotherapy for >/= to 2 weeks and off corticosteroids for >/= to 1 week.
  • Pregnant or nursing women.
  • Patients who are primarily refactory to erlotinib.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569114


Locations
United States, California
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
City of Hope
Duarte, California, United States
University of Southern California
Los Angeles, California, United States
University of California at Davis
Sacramento, California, United States
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States
Sponsors and Collaborators
Tragara Pharmaceuticals, Inc.
Investigators
Study Director: Sara Zaknoen, MD Tragara Pharmaceuticals

Responsible Party: Sara Zaknoen, MD, Tragara Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00569114     History of Changes
Other Study ID Numbers: TP2001-101
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: March 17, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action