NCT00112060

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2008

Typical duration for phase_1

Geographic Reach
2 countries

13 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2005

Completed
2.8 years until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

March 31, 2014

Status Verified

March 1, 2014

Enrollment Period

3.4 years

First QC Date

May 27, 2005

Last Update Submit

March 27, 2014

Conditions

Non-Small-Cell Lung Carcinoma

Keywords

TalotrexinPT-523Non-Small Cell Lung Carcinoma (NSCLC)

Interventions

PT-523 for InjectionDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 qualify 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of Miami and Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

University of Chicago

Chicago, Illinois, 60637-1470, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Case Western Reserve University & University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Chelyabinsk Regional Oncology Center Chemotherapy Department

Chelyabinsk, 454087, Russia

Location

Irkutsk Regional Oncology Center

Irkutsk, 664035, Russia

Location

Blokhin Cancer Research Center Department of Chemotherapy and Combination Treatment of Neoplasia

Moscow, 115478, Russia

Location

Blokhin Cancer Research Center Department of Clinical Pharmacology and Chemotherapy

Moscow, 115478, Russia

Location

Semashko Central Clinical Hospital

Moscow, 129128, Russia

Location

St. Petersburg Pavlov State Medical University

Saint Petersburg, 197022, Russia

Location

Petrov Research Institute of Oncology

Saint Petersburg, 197758, Russia

Location

St. Petersburg Oncology Center Thoracic Department

Saint Petersburg, 198255, Russia

Location

Yaroslavl City Oncology Center

Yaroslavl, 150054, Russia

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

N(alpha)-(4-amino-4-deoxypteroyl)-N(delta)-hemiphthaloyl-L-ornithineInjections

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2005

First Posted

May 30, 2005

Study Start

April 1, 2008

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

March 31, 2014

Record last verified: 2014-03

Locations

RU(9)US(4)