Trial Outcomes & Findings for Open-label Study of STA-9090 for Patients With Metastatic Breast Cancer (NCT NCT01273896)
NCT ID: NCT01273896
Last Updated: 2015-11-20
Results Overview
To determine the overall response rate using RECIST v 1.1 criteria, defined as PR +CR.using RECIST v 1.1 criteria, defined as Partial response + complete response
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Radiological imaging studies to evaluate tumor status will be repeated during the rest week (Days 22 to 28) of every third cycle
Results posted on
2015-11-20
Participant Flow
Participant milestones
| Measure |
STA-9090
This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.
STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-label Study of STA-9090 for Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
STA-9090
n=22 Participants
This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.
STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Radiological imaging studies to evaluate tumor status will be repeated during the rest week (Days 22 to 28) of every third cycleTo determine the overall response rate using RECIST v 1.1 criteria, defined as PR +CR.using RECIST v 1.1 criteria, defined as Partial response + complete response
Outcome measures
| Measure |
STA-9090
n=20 Participants
This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.
STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression.
|
|---|---|
|
Overall Response Rate
|
20 participants
|
Adverse Events
STA-9090
Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
STA-9090
n=22 participants at risk
This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.
STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression.
|
|---|---|
|
Cardiac disorders
Cardiac General, other
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Death not assoc w CTCAE term- Death NOS
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Death not assoc w CTCAE term-Disease prog NOS
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
9.1%
2/22 • Number of events 3
|
|
Hepatobiliary disorders
Liver dysfunction/failure
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malig)
|
4.5%
1/22 • Number of events 2
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
4.5%
1/22 • Number of events 1
|
Other adverse events
| Measure |
STA-9090
n=22 participants at risk
This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.
STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression.
|
|---|---|
|
Investigations
ALT, SGPT
|
9.1%
2/22 • Number of events 5
|
|
Investigations
AST, SGOT
|
18.2%
4/22 • Number of events 9
|
|
Investigations
Alkaline phosphatase
|
18.2%
4/22 • Number of events 8
|
|
Investigations
Amylase
|
9.1%
2/22 • Number of events 7
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
13.6%
3/22 • Number of events 4
|
|
Investigations
CPK (creatine phosphokinase)
|
4.5%
1/22 • Number of events 3
|
|
Investigations
Creatinine
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
4/22 • Number of events 6
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
9.1%
2/22 • Number of events 2
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
18.2%
4/22 • Number of events 7
|
|
Metabolism and nutrition disorders
Glucose, low (hypoglycemia)
|
9.1%
2/22 • Number of events 3
|
|
Investigations
Hemoglobin
|
18.2%
4/22 • Number of events 15
|
|
Vascular disorders
Hypertension
|
4.5%
1/22 • Number of events 1
|
|
Investigations
INR
|
9.1%
2/22 • Number of events 6
|
|
Psychiatric disorders
Insomnia
|
9.1%
2/22 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
4.5%
1/22 • Number of events 1
|
|
Investigations
Lipase
|
9.1%
2/22 • Number of events 4
|
|
Investigations
Lymphopenia
|
18.2%
4/22 • Number of events 5
|
|
Metabolism and nutrition disorders
Magnesium, low (hypomagnesemia)
|
4.5%
1/22 • Number of events 1
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
4.5%
1/22 • Number of events 1
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
4.5%
1/22 • Number of events 2
|
|
Investigations
Platelets
|
4.5%
1/22 • Number of events 2
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
4.5%
1/22 • Number of events 1
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
4.5%
1/22 • Number of events 1
|
|
Investigations
Weight loss
|
4.5%
1/22 • Number of events 1
|
Additional Information
Modi, Shanu/Medicine (Assistant Attending)
Memorial Sloan Kettering Cancer Center
Phone: +1646-888-4564
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place