Trial Outcomes & Findings for SARC018: A Study of Mocetinostat and Gemcitabine in Patients With Metastatic Leiomyosarcoma (NCT NCT02303262)
NCT ID: NCT02303262
Last Updated: 2019-01-29
Results Overview
Response rate (CR or PR) will be calculated by the number of patients achieving a response divided by the number of patients having been evaluated for response. Per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR) is the disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameters of all target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
27 months
Results posted on
2019-01-29
Participant Flow
Participant milestones
| Measure |
Mocetinostat and Gemcitabine
For each 21-day cycle, gemcitabine is administered on days 5 and 12 and mocetinostat is administered 3 days a week.
Mocetinostat: Mocetinostat is taken orally at 70 mg/dose, 3 days per week, during cycle 1. Dose is increased to 90 mg starting at cycle 2.
Gemcitabine: Gemcitabine is administered via intravenous infusion at 1,000 mg/m2 at a rate of approximately 10 mg/m2/minute, on days 5 and 12 of every cycle.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Mocetinostat and Gemcitabine
For each 21-day cycle, gemcitabine is administered on days 5 and 12 and mocetinostat is administered 3 days a week.
Mocetinostat: Mocetinostat is taken orally at 70 mg/dose, 3 days per week, during cycle 1. Dose is increased to 90 mg starting at cycle 2.
Gemcitabine: Gemcitabine is administered via intravenous infusion at 1,000 mg/m2 at a rate of approximately 10 mg/m2/minute, on days 5 and 12 of every cycle.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
SARC018: A Study of Mocetinostat and Gemcitabine in Patients With Metastatic Leiomyosarcoma
Baseline characteristics by cohort
| Measure |
Mocetinostat and Gemcitabine
n=20 Participants
For each 21-day cycle, gemcitabine is administered on days 5 and 12 and mocetinostat is administered 3 days a week.
Mocetinostat: Mocetinostat is taken orally at 70 mg/dose, 3 days per week, during cycle 1. Dose is increased to 90 mg starting at cycle 2.
Gemcitabine: Gemcitabine is administered via intravenous infusion at 1,000 mg/m2 at a rate of approximately 10 mg/m2/minute, on days 5 and 12 of every cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
56.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 27 monthsResponse rate (CR or PR) will be calculated by the number of patients achieving a response divided by the number of patients having been evaluated for response. Per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR) is the disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameters of all target lesions.
Outcome measures
| Measure |
Mocetinostat and Gemcitabine
n=18 Participants
For each 21-day cycle, gemcitabine is administered on days 5 and 12 and mocetinostat is administered 3 days a week.
Mocetinostat: Mocetinostat is taken orally at 70 mg/dose, 3 days per week, during cycle 1. Dose is increased to 90 mg starting at cycle 2.
Gemcitabine: Gemcitabine is administered via intravenous infusion at 1,000 mg/m2 at a rate of approximately 10 mg/m2/minute, on days 5 and 12 of every cycle.
|
|---|---|
|
Response Rate (Per RECIST 1.1)
|
1 Participants
|
SECONDARY outcome
Timeframe: 27 monthsThe duration of objective response will be measured from the time measurement criteria are first met until disease progression is objectively documented.
Outcome measures
| Measure |
Mocetinostat and Gemcitabine
n=18 Participants
For each 21-day cycle, gemcitabine is administered on days 5 and 12 and mocetinostat is administered 3 days a week.
Mocetinostat: Mocetinostat is taken orally at 70 mg/dose, 3 days per week, during cycle 1. Dose is increased to 90 mg starting at cycle 2.
Gemcitabine: Gemcitabine is administered via intravenous infusion at 1,000 mg/m2 at a rate of approximately 10 mg/m2/minute, on days 5 and 12 of every cycle.
|
|---|---|
|
Duration of Response
|
2 months
Interval 1.5 to 3.1
|
SECONDARY outcome
Timeframe: 27 monthsProgression free survival is defined as the time from treatment initiation to the earlier date of assessment of objective progression or death by any cause in the absence of progression. Progression Free Survival (PFS) is defined as the time from treatment initiation to the earlier date of assessment of objective progression or death by any cause in the absence of progression. Progression will be assessed by RECIST v. 1.1.
Outcome measures
| Measure |
Mocetinostat and Gemcitabine
n=18 Participants
For each 21-day cycle, gemcitabine is administered on days 5 and 12 and mocetinostat is administered 3 days a week.
Mocetinostat: Mocetinostat is taken orally at 70 mg/dose, 3 days per week, during cycle 1. Dose is increased to 90 mg starting at cycle 2.
Gemcitabine: Gemcitabine is administered via intravenous infusion at 1,000 mg/m2 at a rate of approximately 10 mg/m2/minute, on days 5 and 12 of every cycle.
|
|---|---|
|
Progression Free Survival (PFS)
|
2.0 months
Interval 1.5 to 3.1
|
Adverse Events
Mocetinostat and Gemcitabine
Serious events: 12 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mocetinostat and Gemcitabine
n=20 participants at risk
For each 21-day cycle, gemcitabine is administered on days 5 and 12 and mocetinostat is administered 3 days a week.
Mocetinostat: Mocetinostat is taken orally at 70 mg/dose, 3 days per week, during cycle 1. Dose is increased to 90 mg starting at cycle 2.
Gemcitabine: Gemcitabine is administered via intravenous infusion at 1,000 mg/m2 at a rate of approximately 10 mg/m2/minute, on days 5 and 12 of every cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
2/20 • Number of events 2 • through study completion, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
General disorders
Failure to thrive
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
General disorders
Fever
|
10.0%
2/20 • Number of events 2 • through study completion, an average of 3 months
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
General disorders
Mucositis
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Investigations
Neutropenia
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
General disorders
Non-cardiac chest pain
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
General disorders
Pain
|
10.0%
2/20 • Number of events 2 • through study completion, an average of 3 months
|
|
Cardiac disorders
Pericardial effusion
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Investigations
Platelet count decreased
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Infections and infestations
Pneumonia
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Infections and infestations
Upper respiratory infection
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
Other adverse events
| Measure |
Mocetinostat and Gemcitabine
n=20 participants at risk
For each 21-day cycle, gemcitabine is administered on days 5 and 12 and mocetinostat is administered 3 days a week.
Mocetinostat: Mocetinostat is taken orally at 70 mg/dose, 3 days per week, during cycle 1. Dose is increased to 90 mg starting at cycle 2.
Gemcitabine: Gemcitabine is administered via intravenous infusion at 1,000 mg/m2 at a rate of approximately 10 mg/m2/minute, on days 5 and 12 of every cycle.
|
|---|---|
|
Investigations
Absolute neutrophil count decreased
|
5.0%
1/20 • Number of events 3 • through study completion, an average of 3 months
|
|
General disorders
Achy
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Gastrointestinal disorders
Acid reflux
|
10.0%
2/20 • Number of events 2 • through study completion, an average of 3 months
|
|
Investigations
Alanine Aminotransferase increased
|
5.0%
1/20 • Number of events 2 • through study completion, an average of 3 months
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
2/20 • Number of events 3 • through study completion, an average of 3 months
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
8/20 • Number of events 28 • through study completion, an average of 3 months
|
|
Metabolism and nutrition disorders
Anorexia
|
30.0%
6/20 • Number of events 6 • through study completion, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • Number of events 3 • through study completion, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
2/20 • Number of events 2 • through study completion, an average of 3 months
|
|
Injury, poisoning and procedural complications
Bruising
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Gastrointestinal disorders
Burping
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
Calf tenderness/burning
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
General disorders
Chills
|
10.0%
2/20 • Number of events 2 • through study completion, an average of 3 months
|
|
General disorders
Cord compression
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Gastrointestinal disorders
Constipation
|
15.0%
3/20 • Number of events 3 • through study completion, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Investigations
Creatinine increased
|
5.0%
1/20 • Number of events 2 • through study completion, an average of 3 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
2/20 • Number of events 2 • through study completion, an average of 3 months
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
2/20 • Number of events 2 • through study completion, an average of 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
4/20 • Number of events 8 • through study completion, an average of 3 months
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Number of events 3 • through study completion, an average of 3 months
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
2/20 • Number of events 2 • through study completion, an average of 3 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Nervous system disorders
Dysgeusia
|
20.0%
4/20 • Number of events 4 • through study completion, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.0%
6/20 • Number of events 6 • through study completion, an average of 3 months
|
|
Investigations
Ejection fraction decreased
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Investigations
Elevated LFTs
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Skin and subcutaneous tissue disorders
Erythematous neck rash
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Skin and subcutaneous tissue disorders
Facial acne
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
General disorders
Fatigue
|
60.0%
12/20 • Number of events 22 • through study completion, an average of 3 months
|
|
General disorders
Fever
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Injury, poisoning and procedural complications
Fracture
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Investigations
GGT increased
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 2 • through study completion, an average of 3 months
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • Number of events 2 • through study completion, an average of 3 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
2/20 • Number of events 2 • through study completion, an average of 3 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
2/20 • Number of events 2 • through study completion, an average of 3 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Number of events 2 • through study completion, an average of 3 months
|
|
Psychiatric disorders
Insomnia
|
20.0%
4/20 • Number of events 4 • through study completion, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
Sciatic pain
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Investigations
Lymphocyte count decreased
|
10.0%
2/20 • Number of events 5 • through study completion, an average of 3 months
|
|
General disorders
Malaise
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Nervous system disorders
Memory impairment
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal irritation
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Gastrointestinal disorders
Nausea
|
40.0%
8/20 • Number of events 12 • through study completion, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
Neck stiffness
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Investigations
Neutrophil count decreased
|
40.0%
8/20 • Number of events 18 • through study completion, an average of 3 months
|
|
General disorders
Night sweats
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Skin and subcutaneous tissue disorders
Sore nostril
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
General disorders
Pain
|
10.0%
2/20 • Number of events 3 • through study completion, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
Thigh pain
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Nervous system disorders
Paresthesia
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Cardiac disorders
Pericardial tamponade
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Cardiac disorders
Pericarditis
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
1/20 • Number of events 3 • through study completion, an average of 3 months
|
|
Infections and infestations
Pharyngitis
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Investigations
Platelet count decreased
|
30.0%
6/20 • Number of events 16 • through study completion, an average of 3 months
|
|
Injury, poisoning and procedural complications
Powerport soreness
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Skin and subcutaneous tissue disorders
Pruritic rash
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Blood and lymphatic system disorders
Pulmonary embolism
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Cardiac disorders
QTCF elevated
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Infections and infestations
Fungal infection
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Renal and urinary disorders
Hydronephrosis
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
Right sided chest pain
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
Sharp left sided pain
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Gastrointestinal disorders
Stomatitis
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Infections and infestations
Thrush
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Cardiac disorders
Ventricular arrhythmia
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
5/20 • Number of events 8 • through study completion, an average of 3 months
|
|
Investigations
Weight loss
|
5.0%
1/20 • Number of events 1 • through study completion, an average of 3 months
|
|
Investigations
White blood cell decreased
|
20.0%
4/20 • Number of events 10 • through study completion, an average of 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place