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)
- 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.
- 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.