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

This study has been completed.
Sponsor:
Information provided by:
Tragara Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00569114
First received: December 4, 2007
Last updated: March 16, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
Drug: TG01
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Tragara Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Saftey, maximum tolerated dose, optimal biological dose and pharmacokinetics. [ Time Frame: Baseline, 8, 15 and 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: October 2007
Study Completion Date: November 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: TG01
Drug:TG01tablets given orally QD Drug: erlotinib tablets 150mg QD

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Sara Zaknoen, MD, Tragara Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00569114     History of Changes
Other Study ID Numbers: TP2001-101
Study First Received: December 4, 2007
Last Updated: March 16, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014