Trial Outcomes & Findings for Safety and Efficacy Study of Glufosfamide in Ovarian Cancer (NCT NCT00442598)
NCT ID: NCT00442598
Last Updated: 2015-03-10
Results Overview
Reduction in blood levels of CA 125 of \>50% from baseline, confirmed at the next study cycle.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Duration of study, up to 18 weeks.
Results posted on
2015-03-10
Participant Flow
Participant milestones
| Measure |
Glufosfamide q21 Days
1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle
Glufosfamide
|
Glufosfamide q7 Days Low
1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide
|
Glufosfamide q7 Days High
1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
10
|
0
|
|
Overall Study
Two Cycles
|
5
|
6
|
0
|
|
Overall Study
COMPLETED
|
1
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
0
|
Reasons for withdrawal
| Measure |
Glufosfamide q21 Days
1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle
Glufosfamide
|
Glufosfamide q7 Days Low
1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide
|
Glufosfamide q7 Days High
1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Tumor progression
|
3
|
4
|
0
|
|
Overall Study
Clinical deterioration
|
1
|
2
|
0
|
|
Overall Study
CA125 progression
|
0
|
1
|
0
|
|
Overall Study
Reduced creatinine clearance
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy Study of Glufosfamide in Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Glufosfamide q21 Days
n=7 Participants
1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle
Glufosfamide
|
Glufosfamide q7 Days Low
n=10 Participants
1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide
|
Glufosfamide q7 Days High
1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
—
|
0 participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
—
|
12 participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
1 participants
n=99 Participants
|
4 participants
n=107 Participants
|
—
|
5 participants
n=7 Participants
|
|
Age, Continuous
|
60 years
n=99 Participants
|
52 years
n=107 Participants
|
—
|
58 years
n=7 Participants
|
|
Gender
Female
|
7 participants
n=99 Participants
|
10 participants
n=107 Participants
|
—
|
17 participants
n=7 Participants
|
|
Gender
Male
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
—
|
0 participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
—
|
0 participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
—
|
0 participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
—
|
0 participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
—
|
0 participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
7 participants
n=99 Participants
|
10 participants
n=107 Participants
|
—
|
17 participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
—
|
0 participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
—
|
0 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Duration of study, up to 18 weeks.Reduction in blood levels of CA 125 of \>50% from baseline, confirmed at the next study cycle.
Outcome measures
| Measure |
Glufosfamide q21 Days
n=7 Participants
1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle
Glufosfamide
|
Glufosfamide q7 Days Low
n=10 Participants
1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide
|
Glufosfamide q7 Days High
1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide
|
|---|---|---|---|
|
CA 125 Response Rate
Stable disease
|
6 participants
|
10 participants
|
—
|
|
CA 125 Response Rate
Partial response
|
1 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Duration of study, up to 18 weeks.Objective response rate measured by RECIST v1.0
Outcome measures
| Measure |
Glufosfamide q21 Days
n=7 Participants
1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle
Glufosfamide
|
Glufosfamide q7 Days Low
n=10 Participants
1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide
|
Glufosfamide q7 Days High
1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide
|
|---|---|---|---|
|
Objective Response Rate
Stable disease
|
3 participants
|
3 participants
|
—
|
|
Objective Response Rate
Progressive disease
|
4 participants
|
7 participants
|
—
|
SECONDARY outcome
Timeframe: Median measured in monthsTime from initiation of study drug to disease progression or death on study
Outcome measures
| Measure |
Glufosfamide q21 Days
n=7 Participants
1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle
Glufosfamide
|
Glufosfamide q7 Days Low
n=10 Participants
1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide
|
Glufosfamide q7 Days High
1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide
|
|---|---|---|---|
|
Progression-free Survival
|
1.2 months
Interval 0.7 to 4.6
|
1.9 months
Interval 0.0 to 4.5
|
—
|
SECONDARY outcome
Timeframe: Median measured in months, until death or censorship at analysis.Time from initiation of study drug to death.
Outcome measures
| Measure |
Glufosfamide q21 Days
n=7 Participants
1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle
Glufosfamide
|
Glufosfamide q7 Days Low
n=10 Participants
1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide
|
Glufosfamide q7 Days High
1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide
|
|---|---|---|---|
|
Overall Survival
|
5.6 months
Interval 1.6 to 13.7
|
6.8 months
Interval 0.9 to 8.5
|
—
|
Adverse Events
Glufosfamide q21 Days
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Glufosfamide q7 Days Low
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Glufosfamide q21 Days
n=7 participants at risk
1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle
Glufosfamide
|
Glufosfamide q7 Days Low
n=10 participants at risk
1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide
|
|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/7
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Renal and urinary disorders
Renal failure
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
Other adverse events
| Measure |
Glufosfamide q21 Days
n=7 participants at risk
1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle
Glufosfamide
|
Glufosfamide q7 Days Low
n=10 participants at risk
1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Glufosfamide
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Lymphadenitis bacterial
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Sinusitis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7
|
20.0%
2/10 • Number of events 2
|
|
Infections and infestations
Viral infection
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor associated fever
|
0.00%
0/7
|
10.0%
1/10 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia
|
28.6%
2/7 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Neutropenia
|
71.4%
5/7 • Number of events 6
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
1/7 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
|
Metabolism and nutrition disorders
Decreased apetite
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
42.9%
3/7 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
14.3%
1/7 • Number of events 2
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.6%
2/7 • Number of events 2
|
10.0%
1/10 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
14.3%
1/7 • Number of events 2
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Depression
|
28.6%
2/7 • Number of events 2
|
20.0%
2/10 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1
|
20.0%
2/10 • Number of events 3
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • Number of events 3
|
0.00%
0/10
|
|
Nervous system disorders
Paraesthesia
|
14.3%
1/7 • Number of events 1
|
10.0%
1/10 • Number of events 2
|
|
Nervous system disorders
Visual field defect
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
Photophobia
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
Photopsia
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
2/7 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Number of events 1
|
20.0%
2/10 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
57.1%
4/7 • Number of events 4
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Gingivitis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Nausea
|
85.7%
6/7 • Number of events 10
|
40.0%
4/10 • Number of events 5
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • Number of events 4
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
28.6%
2/7 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/7
|
10.0%
1/10 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Hydronephrosis
|
14.3%
1/7 • Number of events 2
|
0.00%
0/10
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/7
|
20.0%
2/10 • Number of events 2
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Asthenia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Catheter related complication
|
14.3%
1/7 • Number of events 4
|
0.00%
0/10
|
|
General disorders
Catheter site pain
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Chest pain
|
14.3%
1/7 • Number of events 2
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Chills
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Fatigue
|
71.4%
5/7 • Number of events 8
|
40.0%
4/10 • Number of events 5
|
|
General disorders
Influenza like illness
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Oedema peripheral
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Performance status decreased
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Temperature intolerance
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Weight decreased
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place