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

Eleison Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Soft Tissue Sarcoma

Treatments

Drug: Glufosfamide

Study type

Interventional

Funder types

Industry

Identifiers

TH-CR-305

Details and patient eligibility

About

Primary Objective:

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

Secondary Objectives:

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
To evaluate the safety of glufosfamide in subjects with advanced soft tissue sarcoma

Exploratory Objectives:

To evaluate the biological effect of glufosfamide on the metabolic profile in subjects with advanced soft tissue sarcomas, as determined by FDG-PET
To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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