Trial Outcomes & Findings for Safety and Efficacy Study of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma (NCT NCT00441467)
NCT ID: NCT00441467
Last Updated: 2015-03-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Tumor assessments were performed at baseline and every 6 weeks until disease progression was documented.
Results posted on
2015-03-25
Participant Flow
Participant milestones
| Measure |
Glufosfamide
Glufosfamide
Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
2 Cycles
|
17
|
|
Overall Study
4 Cycles
|
7
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Glufosfamide
Glufosfamide
Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Progressive disease
|
9
|
Baseline Characteristics
Safety and Efficacy Study of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
Glufosfamide
n=22 Participants
Glufosfamide
Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
53.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Tumor assessments were performed at baseline and every 6 weeks until disease progression was documented.Population: Patients receiving glufosfamide with a post treatment imaging assessment
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.
Outcome measures
| Measure |
Glufosfamide
n=19 Participants
Glufosfamide
Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.
|
|---|---|
|
Objective Response Rate
Partial response
|
1 participants
|
|
Objective Response Rate
Stable disease
|
7 participants
|
|
Objective Response Rate
Progressive disease
|
11 participants
|
SECONDARY outcome
Timeframe: 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.Outcome measures
| Measure |
Glufosfamide
n=22 Participants
Glufosfamide
Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.
|
|---|---|
|
Progression-free Survival
|
1.3 months
Interval 1.3 to 3.9
|
SECONDARY outcome
Timeframe: 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.Outcome measures
| Measure |
Glufosfamide
n=22 Participants
Glufosfamide
Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.
|
|---|---|
|
Overall Survival
|
10.5 months
Interval 6.3 to 13.6
|
Adverse Events
Glufosfamide
Serious events: 7 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Glufosfamide
n=22 participants at risk
Glufosfamide
Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.
|
|---|---|
|
Renal and urinary disorders
Renal failure
|
22.7%
5/22 • Number of events 5
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Intractable nausea and vomiting
|
4.5%
1/22 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma site hemorrhage
|
4.5%
1/22 • Number of events 1
|
Other adverse events
| Measure |
Glufosfamide
n=22 participants at risk
Glufosfamide
Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
2/22 • Number of events 3
|
|
Blood and lymphatic system disorders
Anemia aggravated
|
13.6%
3/22 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.2%
4/22 • Number of events 4
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
2/22 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
18.2%
4/22 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.1%
2/22 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
9.1%
2/22 • Number of events 2
|
|
Psychiatric disorders
Depression aggravated
|
9.1%
2/22 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
13.6%
3/22 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
9.1%
2/22 • Number of events 2
|
|
Nervous system disorders
Headache
|
9.1%
2/22 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
2/22 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
2/22 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exacerbated
|
9.1%
2/22 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal bloating
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Constipation agravated
|
9.1%
2/22 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis oral
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
50.0%
11/22 • Number of events 20
|
|
Gastrointestinal disorders
Nausea aggravated
|
13.6%
3/22 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
11/22 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.7%
5/22 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain aggravated
|
9.1%
2/22 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain aggravated
|
9.1%
2/22 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
9.1%
2/22 • Number of events 2
|
|
General disorders
Fatigue
|
22.7%
5/22 • Number of events 6
|
|
General disorders
Fatigue aggravated
|
13.6%
3/22 • Number of events 3
|
|
General disorders
General body pain
|
9.1%
2/22 • Number of events 2
|
|
General disorders
Weakness
|
9.1%
2/22 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place