Phase 1 Study of TG01 and Erlotinib in Non-small Cell Lung Cancer (NCSLC) Patients
A Phase 1 Dose-Escalation Pharmacokinetic and Pharmacodynamic Study of TG01 Tablets in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients
1 other identifier
interventional
45
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 nonsmall-cell-lung-cancer
Started Oct 2007
Shorter than P25 for phase_1 nonsmall-cell-lung-cancer
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 4, 2007
CompletedFirst Posted
Study publicly available on registry
December 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedMarch 17, 2010
March 1, 2010
1.5 years
December 4, 2007
March 16, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Saftey, maximum tolerated dose, optimal biological dose and pharmacokinetics.
Baseline, 8, 15 and 28 days
Study Arms (1)
1
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
Nevada Cancer Institute
Las Vegas, Nevada, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sara Zaknoen, MD
Tragara Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 4, 2007
First Posted
December 6, 2007
Study Start
October 1, 2007
Primary Completion
April 1, 2009
Study Completion
November 1, 2009
Last Updated
March 17, 2010
Record last verified: 2010-03