Clinical trial NCT00112060: A Study to Assess the Safety and Preliminary Efficacy of PT-523 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Non-Small-Cell Lung Carcinoma
Keywords: Talotrexin
PT-523
Non-Small Cell Lung Carcinoma (NSCLC)
Lead sponsor: Spectrum Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2005-05-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami and Sylvester Comprehensive Cancer Center
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve University & University Hospitals of Cleveland
state: Ohio
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Oncology Center Chemotherapy Department
city: Irkutsk
country: Russian Federation
facility: Irkutsk Regional Oncology Center
city: Moscow
country: Russian Federation
facility: Blokhin Cancer Research Center Department of Chemotherapy and Combination Treatment of Neoplasia
city: Moscow
country: Russian Federation
facility: Blokhin Cancer Research Center Department of Clinical Pharmacology and Chemotherapy
city: Moscow
country: Russian Federation
facility: Semashko Central Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Pavlov State Medical University
city: St. Petersburg
country: Russian Federation
facility: Petrov Research Institute of Oncology
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Oncology Center Thoracic Department
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl City Oncology Center
Study officials:
References: