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

March 16, 2010 updated by: Tragara Pharmaceuticals, Inc.

A Phase 1 Dose-Escalation Pharmacokinetic and Pharmacodynamic Study of TG01 Tablets in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Bakersfield, California, United States
        • Comprehensive Blood and Cancer Center
      • Duarte, California, United States
        • City of Hope
      • Los Angeles, California, United States
        • University of Southern California
      • Sacramento, California, United States
        • University of California at Davis
    • Nevada
      • Las Vegas, Nevada, United States
        • Nevada Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Drug: TG01
Drug:TG01tablets given orally QD Drug: erlotinib tablets 150mg QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Saftey, maximum tolerated dose, optimal biological dose and pharmacokinetics.
Time Frame: Baseline, 8, 15 and 28 days
Baseline, 8, 15 and 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tragara Pharmaceuticals, Inc.

Investigators

  • Study Director: Sara Zaknoen, MD, Tragara Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

December 4, 2007

First Submitted That Met QC Criteria

December 5, 2007

First Posted (Estimate)

December 6, 2007

Study Record Updates

Last Update Posted (Estimate)

March 17, 2010

Last Update Submitted That Met QC Criteria

March 16, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP2001-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-small Cell Lung Cancer

Clinical Trials on TG01

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe