Overview
A Study to Assess the Safety and Preliminary Efficacy of PT-523 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Status:
Withdrawn
Withdrawn
Trial end date:
2011-09-01
2011-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This phase I/II, multi-centered, non-randomized trial is designed to determine a safe dose of PT-523 for subjects, and to make preliminary evaluations on the activity of PT-523 as therapy in subjects with NSCLC.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Criteria
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.