Soft Tissue SarcomaPhase 2NCT00441467
Safety and Efficacy Study of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma
A Phase 2 study testing Glufosfamide in people with Soft Tissue Sarcoma, run by Eleison Pharmaceuticals LLC. at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Glufosfamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2007to Oct 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, 87131
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011
Premiere Oncology of Arizona
Scottsdale, Arizona, 85260
Washington University School of Medicine, Division of Oncology
St Louis, Missouri, 63110
Stanford Cancer Center
Stanford, California, 94305
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: An Open-Label Phase 2 Study of the Efficacy and Safety of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma
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
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Glufosfamide
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlufosfamideDrug
5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Glufosfamide | Experimental | Glufosfamide Receives: Drug: Glufosfamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
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.
Measured: Tumor assessments were performed at baseline and every 6 weeks until disease progression was documented.
Secondary outcomes (2)
Progression-free Survival
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eleison Pharmaceuticals LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Threshold Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Lee Cranmer, MD, PhD, Principal investigator, University of ArizonaDavid Mendelson, MD, Principal investigator, Premiere Oncology of ArizonaDouglas Adkins, MD, Principal investigator, Washington University School of Medicine, Division of OncologyGina D'Amato, MD, Principal investigator, H. Lee Moffitt Cancer CenterGerald Rosen, MD, Principal investigator, St. Vincent's Comprehensive Cancer CenterClaire Verschraegen, MD, Principal investigator, University of New Mexico Cancer CenterKristen Ganjoo, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441467
- Sponsor's protocol ID
- TH-CR-305
- Status last verified
- Mar 2015
- First submitted
- 27 Feb 2007
- Last updated
- 25 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 2 Study of the Efficacy and Safety of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT00441467
- Acronym / sponsor ID
- TH-CR-305
- Conditions
- Soft Tissue Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Eleison Pharmaceuticals LLC.Industry (pharma, biotech, devices)
- Collaborators
- Threshold Pharmaceuticals
- Study start
- Mar 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 1 Mar 2007 (estimated)
- Results
- Posted 2 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glufosfamide | Experimental | Drug: GlufosfamideGlufosfamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glufosfamide5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles. | Drug | Glufosfamide |
Primary outcome
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.
2 secondary outcomes
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Cranmer, MD, PhD principal investigator
University of Arizona
David Mendelson, MD principal investigator
Premiere Oncology of Arizona
Douglas Adkins, MD principal investigator
Washington University School of Medicine, Division of Oncology
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glufosfamide in people with Soft Tissue Sarcoma, run by Eleison Pharmaceuticals LLC. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Tumor assessments were performed at baseline and every 6 weeks until disease progression was documented.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.