Trial | NCT00569114  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    45
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 Started
Oct 31
2007
Primary Completion
Apr 30
2009
Study Completion
Nov 30
2009
Last Update
Mar 17
2010
Estimate

Drug TG01

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

1 Other

Criteria 

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.
No Results Posted