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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.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Soft Tissue Sarcoma
Intervention Drug: Glufosfamide
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Glufosfamide
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Glufosfamide

Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.
Period Title: Overall Study
Started 22
2 Cycles 17
4 Cycles 7
Completed 4
Not Completed 18
Reason Not Completed
Adverse Event             6
Withdrawal by Subject             3
Progressive disease             9
Arm/Group Title Glufosfamide
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Glufosfamide

Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
  81.8%
>=65 years
4
  18.2%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants
53.5
(19 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
11
  50.0%
Male
11
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   4.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   9.1%
White
19
  86.4%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Objective Response Rate
Hide Description 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.
Time Frame Tumor assessments were performed at baseline and every 6 weeks until disease progression was documented.
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Hide Analysis Population Description
Patients receiving glufosfamide with a post treatment imaging assessment
Arm/Group Title Glufosfamide
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Glufosfamide

Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: participants
Partial response 1
Stable disease 7
Progressive disease 11
2.Secondary Outcome
Title Progression-free Survival
Hide Description [Not Specified]
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.
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glufosfamide
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Glufosfamide

Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.
Overall Number of Participants Analyzed 22
Median (95% Confidence Interval)
Unit of Measure: months
1.3
(1.3 to 3.9)
3.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
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.
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glufosfamide
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Glufosfamide

Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.
Overall Number of Participants Analyzed 22
Median (95% Confidence Interval)
Unit of Measure: months
10.5
(6.3 to 13.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Glufosfamide
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Glufosfamide

Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.
All-Cause Mortality
Glufosfamide
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Glufosfamide
Affected / at Risk (%) # Events
Total   7/22 (31.82%)    
Gastrointestinal disorders   
Intractable nausea and vomiting  1/22 (4.55%)  2
Metabolism and nutrition disorders   
Dehydration  2/22 (9.09%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Sarcoma site hemorrhage  1/22 (4.55%)  1
Renal and urinary disorders   
Renal failure  5/22 (22.73%)  5
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Glufosfamide
Affected / at Risk (%) # Events
Total   22/22 (100.00%)    
Blood and lymphatic system disorders   
Anemia  2/22 (9.09%)  3
Anemia aggravated  3/22 (13.64%)  3
Neutropenia  4/22 (18.18%)  4
Thrombocytopenia  2/22 (9.09%)  2
Gastrointestinal disorders   
Abdominal bloating  2/22 (9.09%)  2
Abdominal pain  2/22 (9.09%)  2
Constipation  2/22 (9.09%)  2
Constipation agravated  2/22 (9.09%)  3
Diarrhea  2/22 (9.09%)  2
Mucositis oral  2/22 (9.09%)  2
Nausea  11/22 (50.00%)  20
Nausea aggravated  3/22 (13.64%)  3
Vomiting  11/22 (50.00%)  12
General disorders   
Fatigue  5/22 (22.73%)  6
Fatigue aggravated  3/22 (13.64%)  3
General body pain  2/22 (9.09%)  2
Weakness  2/22 (9.09%)  2
Metabolism and nutrition disorders   
Anorexia  4/22 (18.18%)  4
Hypokalemia  2/22 (9.09%)  3
Hypophosphatemia  2/22 (9.09%)  2
Musculoskeletal and connective tissue disorders   
Back pain aggravated  2/22 (9.09%)  2
Pain aggravated  2/22 (9.09%)  2
Shoulder pain  2/22 (9.09%)  2
Nervous system disorders   
Dizziness  2/22 (9.09%)  2
Headache  2/22 (9.09%)  2
Psychiatric disorders   
Depression aggravated  2/22 (9.09%)  2
Insomnia  3/22 (13.64%)  3
Respiratory, thoracic and mediastinal disorders   
Cough  2/22 (9.09%)  2
Dyspnea  2/22 (9.09%)  2
Dyspnea exacerbated  2/22 (9.09%)  2
Sore throat  2/22 (9.09%)  2
Skin and subcutaneous tissue disorders   
Alopecia  5/22 (22.73%)  5
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: VP Clinical Development
Organization: Eleison Pharmaceuticals
Phone: 6097211227
EMail: matthew.parris@eleison-pharma.com
Layout table for additonal information
Responsible Party: Eleison Pharmaceuticals LLC.
ClinicalTrials.gov Identifier: NCT00441467    
Other Study ID Numbers: TH-CR-305
First Submitted: February 27, 2007
First Posted: March 1, 2007
Results First Submitted: February 16, 2015
Results First Posted: March 2, 2015
Last Update Posted: March 25, 2015