Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn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Status Withdrawn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Status Withdrawn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


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, 

See also
  Status Clinical Trial Phase
Completed NCT00985855 - Feasibility of Cetuximab Associated With Concomitant Radio-Chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer Phase 2
Completed NCT01048645 - Effect of All-trans Retinoic Acid With Chemotherapy Based in Paclitaxel and Cisplatin as First Line Treatment of Patients With Advanced Non-small Cell Lung Cancer Phase 2
Completed NCT00129844 - Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer Phase 2
Completed NCT00098085 - Study of the Feasibility to Derive Vaccine From Tumor Tissue in Patients With Non-Small Cell Lung Cancer Phase 2
Active, not recruiting NCT04995523 - A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC Phase 1/Phase 2
Completed NCT00910676 - Study About Preventive Treatment of Folliculitis Induced by Epidermal Growth Factor Receptor Inhibitors Phase 2
Withdrawn NCT00108186 - Celecoxib Treatment for Lung Cancer Phase 1
Recruiting NCT05037825 - The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors
Recruiting NCT00379717 - Concurrent Helical Tomotherapy With Chemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC) Phase 1/Phase 2
Completed NCT00404924 - ZD6474 (ZACTIMAâ„¢) Phase III Study in EGFR Failures Phase 3
Completed NCT00102505 - A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC) Phase 1
Recruiting NCT02905591 - A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC Phase 2
Active, not recruiting NCT03088540 - Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) Phase 3
Terminated NCT00271323 - Safety Study of Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in NSCLC Patients Phase 2
Terminated NCT00232206 - Trial of Neoadjuvant Docetaxel and Cisplatin for Resectable Non-Small Cell Lung Cancer Phase 2
Completed NCT00037817 - Phase I Study of Gene Induction Mediated by Sequential Decitabine/Depsipeptide Infusion With or Without Concurrent Celecoxib in Subjects With Pulmonary and Pleural Malignancies Phase 1
Completed NCT03444766 - Study of Nivolumab for Advanced Cancers in India Phase 4
Completed NCT04351334 - Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns
Active, not recruiting NCT02416739 - Anticancer Activity of Nicotinamide on Lung Cancer Phase 2/Phase 3
Completed NCT00444015 - Phase I Dasatinib/Erlotinib in Recurrent Non-small Cell Lung Cancer (NSCLC) Phase 1