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

Phase 1

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: TG01

• Registration Number: NCT00569114
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-05
• Study First Posted: 2007-12-06
• Primary Completion: 2009-04
• Study Completion: 2009-11
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-16
• Last Update Posted: 2010-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	TG01	-

Primary Outcome Measures

Name	Time	Method
Saftey, maximum tolerated dose, optimal biological dose and pharmacokinetics.	Baseline, 8, 15 and 28 days

Trial Locations

Locations (5)

City of Hope; 🇺🇸 Duarte, California, United States

Nevada Cancer Institute; 🇺🇸 Las Vegas, Nevada, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

University of California at Davis; 🇺🇸 Sacramento, California, United States

Comprehensive Blood and Cancer Center; 🇺🇸 Bakersfield, California, United States