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Trial record 2 of 9 for:    glufosfamide

Safety and Efficacy Study of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT00441467
Recruitment Status : Completed
First Posted : March 1, 2007
Results First Posted : March 2, 2015
Last Update Posted : March 25, 2015
Sponsor:
Collaborator:
Threshold Pharmaceuticals
Information provided by (Responsible Party):
Eleison Pharmaceuticals LLC.

Tracking Information
First Submitted Date  ICMJE February 27, 2007
First Posted Date  ICMJE March 1, 2007
Results First Submitted Date  ICMJE February 16, 2015
Results First Posted Date  ICMJE March 2, 2015
Last Update Posted Date March 25, 2015
Study Start Date  ICMJE March 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
Objective Response Rate [ Time Frame: Tumor assessments were performed at baseline and every 6 weeks until disease progression was documented. ]
The event rate was the response rate (complete and partial response) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.0). The associated 95% exact binomial confidence intervals were calculated.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
  • Progression-free Survival [ Time Frame: All subjects were followed regularly until glufosfamide discontinuation, tumor progression or additional antitumor therapy was started and then were followed for survival at 3 month intervals for the first year and once every year thereafter until death. ]
  • Overall Survival [ Time Frame: All subjects were followed regularly until glufosfamide discontinuation, tumor progression or additional antitumor therapy was started and then were followed for survival at 3 month intervals for the first year and once every year thereafter until death. ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma
Official Title  ICMJE An Open-Label Phase 2 Study of the Efficacy and Safety of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma
Brief Summary

Primary Objective:

1. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by objective response rate

Secondary Objectives:

  1. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by duration of response, progression-free survival and overall survival
  2. To evaluate the safety of glufosfamide in subjects with advanced soft tissue sarcoma

Exploratory Objectives:

  1. To evaluate the biological effect of glufosfamide on the metabolic profile in subjects with advanced soft tissue sarcomas, as determined by FDG-PET
  2. To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Soft Tissue Sarcoma
Intervention  ICMJE Drug: Glufosfamide
5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.
Study Arms  ICMJE Experimental: Glufosfamide
Glufosfamide
Intervention: Drug: Glufosfamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2007)
22
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 18 years of age
  • Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
  • Pathologically confirmed diagnosis of soft tissue sarcoma
  • Locally advanced unresectable or metastatic disease with no standard curative therapy available that has progressed since the most recent therapy
  • Measurable disease by RECIST criteria with at least one target lesion
  • 1 or 2 prior chemotherapy/systemic therapy regimens for advanced disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
  • A minimum of 3 weeks between prior chemotherapy, radiation therapy, immunotherapy, or other anti-tumor therapy and study entry
  • Recovered from reversible toxicities of prior therapy
  • Hemoglobin ≥ 9.0 g/dL, neutrophils ≥ 1,500/µL, platelets ≥ 100,000/µL
  • Total bilirubin ≤ 1.5-fold ULN, AST/ALT ≤ 2.5-fold ULN (≤ 5-fold if liver metastases)
  • Normal creatinine clearance (≥85 mL/min for men and ≥75 mL/min for women; calculated by Cockcroft-Gault formula
  • All women of childbearing potential must have a negative serum pregnancy test and all subjects must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose

Exclusion Criteria:

  • Soft tissue sarcoma of the following subtypes: gastrointestinal stromal tumor (GIST), alveolar soft parts sarcoma, hemangiopericytoma and Kaposi's sarcoma
  • Most recent relapse occurring during treatment with ifosfamide within 4 weeks of last dose
  • Symptomatic brain or leptomeningeal metastases
  • Active clinically significant infection requiring antibiotics
  • Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, cerebrovascular accident or congestive heart failure
  • Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years
  • Major surgery within 3 weeks of the start of study treatment, without complete recovery
  • Females who are pregnant or breast-feeding
  • Participation in an investigational drug or device study within 21 days of study entry
  • Concomitant disease or condition that could interfere with the conduct of the study, or that in the opinion of the investigator would pose an unacceptable risk to the subject in this study
  • Unwillingness or inability to comply with the study protocol for any other reason
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00441467
Other Study ID Numbers  ICMJE TH-CR-305
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eleison Pharmaceuticals LLC.
Study Sponsor  ICMJE Eleison Pharmaceuticals LLC.
Collaborators  ICMJE Threshold Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Lee Cranmer, MD, PhD University of Arizona
Principal Investigator: David Mendelson, MD Premiere Oncology of Arizona
Principal Investigator: Douglas Adkins, MD Washington University School of Medicine, Division of Oncology
Principal Investigator: Gina D'Amato, MD H. Lee Moffitt Cancer Center
Principal Investigator: Gerald Rosen, MD St. Vincent's Comprehensive Cancer Center
Principal Investigator: Claire Verschraegen, MD University of New Mexico Cancer Center
Principal Investigator: Kristen Ganjoo, MD Stanford University
PRS Account Eleison Pharmaceuticals LLC.
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP