NCT00569114
Completed
Phase 1
A Phase 1 Dose-Escalation Pharmacokinetic and Pharmacodynamic Study of TG01 Tablets in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients
Tragara Pharmaceuticals, Inc.5 sites in 1 country45 target enrollmentStarted: October 2007Last updated:
Overview
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 45
- Locations
- 5
- Primary Endpoint
- Saftey, maximum tolerated dose, optimal biological dose and pharmacokinetics.
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Other
Intervention: TG01 (Drug)
Outcomes
Primary Outcomes
Saftey, maximum tolerated dose, optimal biological dose and pharmacokinetics.
Time Frame: Baseline, 8, 15 and 28 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (5)
Loading locations...
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