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

Non-Small-Cell Lung Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00112060
• Other study ID #: HBS101
• Secondary ID: HBS101.00
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: May 27, 2005
• Last updated: March 27, 2014
• Start date: April 2008
• Est. completion date: September 2011

Study information

• Verified date: March 2014
• Source: Spectrum Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Carcinoma

Intervention

Drug:
• PT-523 for Injection

Locations

Country	Name	City	State
Russian Federation	Chelyabinsk Regional Oncology Center Chemotherapy Department	Chelyabinsk
Russian Federation	Irkutsk Regional Oncology Center	Irkutsk
Russian Federation	Blokhin Cancer Research Center Department of Chemotherapy and Combination Treatment of Neoplasia	Moscow
Russian Federation	Blokhin Cancer Research Center Department of Clinical Pharmacology and Chemotherapy	Moscow
Russian Federation	Semashko Central Clinical Hospital	Moscow
Russian Federation	Petrov Research Institute of Oncology	St. Petersburg
Russian Federation	St. Petersburg Oncology Center Thoracic Department	St. Petersburg
Russian Federation	St. Petersburg Pavlov State Medical University	St. Petersburg
Russian Federation	Yaroslavl City Oncology Center	Yaroslavl
United States	University of Chicago	Chicago	Illinois
United States	Case Western Reserve University & University Hospitals of Cleveland	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Miami and Sylvester Comprehensive Cancer Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Russian Federation,