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


Phase 1
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Saftey, maximum tolerated dose, optimal biological dose and pharmacokinetics.

Outcome Time Frame:

Baseline, 8, 15 and 28 days

Safety Issue:

No

Principal Investigator

Sara Zaknoen, MD

Investigator Role:

Study Director

Investigator Affiliation:

Tragara Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

TP2001-101

NCT ID:

NCT00569114

Start Date:

October 2007

Completion Date:

November 2009

Related Keywords:

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

Name

Location

Comprehensive Blood and Cancer CenterBakersfield, California  93309
City of HopeDuarte, California  91010
University of Southern CaliforniaLos Angeles, California  90033
Nevada Cancer InstituteLas Vegas, Nevada  89135
University of California at DavisSacramento, California  95817