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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569114
• Other study ID #: TP2001-101
• Status: Completed
• Phase: Phase 1
• First received: December 4, 2007
• Last updated: March 16, 2010
• Start date: October 2007
• Est. completion date: November 2009

Study information

• Verified date: March 2010
• Source: Tragara Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• TG01
Drug:TG01tablets given orally QD Drug: erlotinib tablets 150mg QD

Locations

Country	Name	City	State
United States	Comprehensive Blood and Cancer Center	Bakersfield	California
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Tragara Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Saftey, maximum tolerated dose, optimal biological dose and pharmacokinetics.		Baseline, 8, 15 and 28 days	No