Know Cancer

or
forgot password

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 Center Durham, North Carolina  27710
University of Chicago Chicago, Illinois  60637
University of Miami and Sylvester Comprehensive Cancer Center Miami, Florida  33136
Case Western Reserve University & University Hospitals of Cleveland Cleveland, Ohio  44106