A Study to Assess the Safety and Preliminary Efficacy of PT-523 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

March 27, 2014 updated by: Spectrum Pharmaceuticals, Inc

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)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Chelyabinsk, Russian Federation, 454087
        • Chelyabinsk Regional Oncology Center Chemotherapy Department
      • Irkutsk, Russian Federation, 664035
        • Irkutsk Regional Oncology Center
      • Moscow, Russian Federation, 129128
        • Semashko Central Clinical Hospital
      • Moscow, Russian Federation, 115478
        • Blokhin Cancer Research Center Department of Chemotherapy and Combination Treatment of Neoplasia
      • Moscow, Russian Federation, 115478
        • Blokhin Cancer Research Center Department of Clinical Pharmacology and Chemotherapy
      • St. Petersburg, Russian Federation, 197022
        • St. Petersburg Pavlov State Medical University
      • St. Petersburg, Russian Federation, 197758
        • Petrov Research Institute of Oncology
      • St. Petersburg, Russian Federation, 198255
        • St. Petersburg Oncology Center Thoracic Department
      • Yaroslavl, Russian Federation, 150054
        • Yaroslavl City Oncology Center
  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami and Sylvester Comprehensive Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University & University Hospitals of Cleveland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectrum Pharmaceuticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 27, 2005

First Submitted That Met QC Criteria

May 27, 2005

First Posted (Estimate)

May 30, 2005

Study Record Updates

Last Update Posted (Estimate)

March 31, 2014

Last Update Submitted That Met QC Criteria

March 27, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBS101
  • HBS101.00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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