Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Spectrum Pharmaceuticals, Inc
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Study to Assess the Safety and Preliminary Efficacy of PT-523 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)