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A Phase I/II, Open-Label, Multicenter Study of Single Agent PT-523 in the Treatment of Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small-Cell Lung Carcinoma

Thank you

Trial Information

A Phase I/II, Open-Label, Multicenter Study of Single Agent PT-523 in the Treatment of Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)


Inclusion Criteria:



- Age ≥ 18 years

- Histologically or cytologically confirmed NSCLC which is stage III or stage IV, or
recurrent disease, and failed therapy with a standard first line (Phase I/II) as well
as second line chemotherapy regimen (Phase I), or be intolerant of standard
chemotherapy. Receipt of one additional prior chemotherapy regimen for neoadjuvant,
adjuvant, or neoadjuvant plus adjuvant is allowable. A prior epidermal growth factor
receptor tyrosine kinase inhibitor (EGFR-TK) antagonist is allowable (Phase II).

- Asymptomatic or treated brain metastases (including steroids) if last therapy was
received > 4 weeks from study entry and is deemed by the investigator to have a low
likelihood of rapid deterioration.

- ECOG performance status 0 - 2.

- Adequate organ function and bone marrow reserve.

- Use of appropriate contraceptive method.

- Signed patient informed consent.

Exclusion Criteria:

- Investigational agents within 30 days prior to Day 1 of study.

- Known symptomatic or uncontrolled brain metastases.

- Uncontrolled intercurrent illness.

- Known human immunodeficiency virus (HIV), hepatitis A, B, C, D and E.

- Patient has uncontrolled pleural effusions.

- Patient has received nitrosoureas or mitomycin-C within 6 weeks or other chemotherapy
or radiation therapy within 3 weeks before study entry.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

HBS101

NCT ID:

NCT00112060

Start Date:

April 2008

Completion Date:

September 2011

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Talotrexin
  • PT-523
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Duke University Medical CenterDurham, North Carolina  27710
University of ChicagoChicago, Illinois  60637
University of Miami and Sylvester Comprehensive Cancer CenterMiami, Florida  33136
Case Western Reserve University & University Hospitals of ClevelandCleveland, Ohio  44106