Trial Outcomes & Findings for Study of ENMD-2076 in Patients With Advanced/Metastatic Soft Tissue Sarcoma (NCT NCT01719744)
NCT ID: NCT01719744
Last Updated: 2023-08-01
Results Overview
Number of patients with no progression of disease at 6 months
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
From start of study treatment until disease progression or death, whichever occurs first, up to 6 months.
Results posted on
2023-08-01
Participant Flow
Participant milestones
| Measure |
ENMD-2076
ENMD-2076 capsules, 275 mg once daily, by mouth.
ENMD-2076
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of ENMD-2076 in Patients With Advanced/Metastatic Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
ENMD-2076
n=25 Participants
ENMD-2076 capsules, 275 mg once daily, by mouth.
ENMD-2076
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of study treatment until disease progression or death, whichever occurs first, up to 6 months.Number of patients with no progression of disease at 6 months
Outcome measures
| Measure |
ENMD-2076
n=25 Participants
ENMD-2076 capsules, 275 mg once daily, by mouth.
ENMD-2076
|
|---|---|
|
6-month Progression-free Survival Rate (PFS)
|
12 participants
Interval 3.0 to 31.0
|
SECONDARY outcome
Timeframe: 2 yearsNumber of participants who experienced a grade 3 or higher adverse event. Reporting threshold 5%
Outcome measures
| Measure |
ENMD-2076
n=25 Participants
ENMD-2076 capsules, 275 mg once daily, by mouth.
ENMD-2076
|
|---|---|
|
Number of and Severity of Adverse Events Per Participant
ALANINE AMINOTRANSFERASE INCREASED
|
2 participants
|
|
Number of and Severity of Adverse Events Per Participant
ASPARTATE AMINOTRANSFERASE INCREASED
|
2 participants
|
|
Number of and Severity of Adverse Events Per Participant
VOMITING
|
2 participants
|
|
Number of and Severity of Adverse Events Per Participant
BLOOD BILIRUBIN INCREASED
|
2 participants
|
|
Number of and Severity of Adverse Events Per Participant
HYPOKALEMIA
|
2 participants
|
|
Number of and Severity of Adverse Events Per Participant
LUNG INFECTION
|
2 participants
|
|
Number of and Severity of Adverse Events Per Participant
HYPOXIA
|
2 participants
|
|
Number of and Severity of Adverse Events Per Participant
DEHYDRATION
|
2 participants
|
|
Number of and Severity of Adverse Events Per Participant
DEPRESSED LEVEL OF CONSCIOUSNESS
|
2 participants
|
|
Number of and Severity of Adverse Events Per Participant
HYPERTENSION
|
16 participants
|
|
Number of and Severity of Adverse Events Per Participant
DIARRHEA
|
4 participants
|
SECONDARY outcome
Timeframe: From start of study treatment until disease progression or death, whichever occurs first.Objective Response Rate (ORR) = CR+ PR. ORR is evaluated per RECIST v1.1 criteria. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Outcome measures
| Measure |
ENMD-2076
n=25 Participants
ENMD-2076 capsules, 275 mg once daily, by mouth.
ENMD-2076
|
|---|---|
|
Objective Response Rate
|
8 percentage of participants
Interval 1.0 to 26.0
|
Adverse Events
ENMD-2076
Serious events: 7 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ENMD-2076
n=25 participants at risk
ENMD-2076 capsules, 275 mg once daily, by mouth.
ENMD-2076
|
|---|---|
|
Psychiatric disorders
Agitation
|
4.0%
1/25
|
|
Investigations
Alanine aminotransferase increased
|
4.0%
1/25
|
|
Investigations
Aspartate aminotransferase increased
|
4.0%
1/25
|
|
Gastrointestinal disorders
Colitis
|
4.0%
1/25
|
|
Psychiatric disorders
Confusion
|
4.0%
1/25
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
2/25
|
|
Nervous system disorders
Depressed level of consciousness
|
4.0%
1/25
|
|
Gastrointestinal disorders
Diarrhea
|
8.0%
2/25
|
|
General disorders
Fatigue
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.0%
1/25
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.0%
1/25
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.0%
1/25
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
1/25
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25
|
|
General disorders
Edema limbs
|
4.0%
1/25
|
|
Infections and infestations
Lung infection
|
8.0%
2/25
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
4.0%
1/25
|
Other adverse events
| Measure |
ENMD-2076
n=25 participants at risk
ENMD-2076 capsules, 275 mg once daily, by mouth.
ENMD-2076
|
|---|---|
|
Vascular disorders
HYPERTENSION
|
76.0%
19/25
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
68.0%
17/25
|
|
General disorders
FATIGUE
|
64.0%
16/25
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
56.0%
14/25
|
|
Gastrointestinal disorders
NAUSEA
|
52.0%
13/25
|
|
Gastrointestinal disorders
DIARRHEA
|
44.0%
11/25
|
|
Renal and urinary disorders
PROTEINURIA
|
52.0%
13/25
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
44.0%
11/25
|
|
Gastrointestinal disorders
CONSTIPATION
|
48.0%
12/25
|
|
Investigations
PLATELET COUNT DECREASED
|
44.0%
11/25
|
|
Gastrointestinal disorders
DYSPEPSIA
|
44.0%
11/25
|
|
Nervous system disorders
DIZZINESS
|
36.0%
9/25
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
32.0%
8/25
|
|
Gastrointestinal disorders
DRY MOUTH
|
32.0%
8/25
|
|
Nervous system disorders
HEADACHE
|
32.0%
8/25
|
|
Metabolism and nutrition disorders
GLUCOSE INTOLERANCE
|
28.0%
7/25
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
24.0%
6/25
|
|
Psychiatric disorders
INSOMNIA
|
28.0%
7/25
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
28.0%
7/25
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
28.0%
7/25
|
|
General disorders
EDEMA LIMBS
|
24.0%
6/25
|
|
Gastrointestinal disorders
VOMITING
|
20.0%
5/25
|
|
Renal and urinary disorders
HEMATURIA
|
24.0%
6/25
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
24.0%
6/25
|
|
Blood and lymphatic system disorders
ANEMIA
|
24.0%
6/25
|
|
Psychiatric disorders
ANXIETY
|
24.0%
6/25
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
24.0%
6/25
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
24.0%
6/25
|
|
Cardiac disorders
ELECTROCARDIOGRAM QT CORRECTED INTERVAL
|
20.0%
5/25
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
20.0%
5/25
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
20.0%
5/25
|
|
Investigations
CREATININE INCREASED
|
16.0%
4/25
|
|
General disorders
FEVER
|
16.0%
4/25
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
16.0%
4/25
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
16.0%
4/25
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
16.0%
4/25
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.0%
4/25
|
|
Metabolism and nutrition disorders
ANOREXIA
|
16.0%
4/25
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
16.0%
4/25
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
12.0%
3/25
|
|
Nervous system disorders
DYSGEUSIA
|
12.0%
3/25
|
|
Gastrointestinal disorders
FLATULENCE
|
12.0%
3/25
|
|
General disorders
FLU LIKE SYMPTOMS
|
12.0%
3/25
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
12.0%
3/25
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDRO
|
12.0%
3/25
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
12.0%
3/25
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
12.0%
3/25
|
|
Investigations
WEIGHT GAIN
|
12.0%
3/25
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
12.0%
3/25
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
8.0%
2/25
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
12.0%
3/25
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
12.0%
3/25
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
12.0%
3/25
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
8.0%
2/25
|
|
Eye disorders
BLURRED VISION
|
8.0%
2/25
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
8.0%
2/25
|
|
Gastrointestinal disorders
DYSPHAGIA
|
8.0%
2/25
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
8.0%
2/25
|
|
Endocrine disorders
HYPERTHYROIDISM
|
8.0%
2/25
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
8.0%
2/25
|
|
Nervous system disorders
PARESTHESIA
|
8.0%
2/25
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
8.0%
2/25
|
|
Gastrointestinal disorders
TOOTHACHE
|
8.0%
2/25
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
8.0%
2/25
|
|
Investigations
WEIGHT LOSS
|
8.0%
2/25
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
8.0%
2/25
|
|
Nervous system disorders
CONCENTRATION IMPAIRMENT
|
8.0%
2/25
|
|
Investigations
HEMOGLOBIN INCREASED
|
8.0%
2/25
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
8.0%
2/25
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
8.0%
2/25
|
|
Investigations
GGT INCREASED
|
8.0%
2/25
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
8.0%
2/25
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
8.0%
2/25
|
|
Psychiatric disorders
DEPRESSION
|
8.0%
2/25
|
|
General disorders
EDEMA TRUNK
|
8.0%
2/25
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
8.0%
2/25
|
|
Investigations
LIPASE INCREASED
|
8.0%
2/25
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
8.0%
2/25
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
8.0%
2/25
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place