Trial Outcomes & Findings for Clinical and Translational Study of STA-9090 (NCT NCT01111838)
NCT ID: NCT01111838
Last Updated: 2015-11-20
Results Overview
Patients with measurable disease will be evaluated using RECIST criteria for determination of response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
every 8 weeks
Results posted on
2015-11-20
Participant Flow
Participant milestones
| Measure |
Patients With Refractory Metastatic Colorectal Cancer
Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Patients With Refractory Metastatic Colorectal Cancer
Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
|
|---|---|
|
Overall Study
Patient Ineligible
|
2
|
|
Overall Study
Not Treated
|
3
|
|
Overall Study
Clinical deterioration
|
1
|
|
Overall Study
Other Complicating Disease
|
1
|
Baseline Characteristics
Clinical and Translational Study of STA-9090
Baseline characteristics by cohort
| Measure |
Patients With Refractory Metastatic Colorectal Cancer
n=22 Participants
Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
|
|---|---|
|
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
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 8 weeksPatients with measurable disease will be evaluated using RECIST criteria for determination of response.
Outcome measures
| Measure |
Patients With Refractory Metastatic Colorectal Cancer
n=15 Participants
Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
|
|---|---|
|
To Determine Overall Objective Response.
Progression of Disease (POD)
|
9 participants
|
|
To Determine Overall Objective Response.
Stable Disease (SD)
|
6 participants
|
Adverse Events
Patients With Refractory Metastatic Colorectal Cancer
Serious events: 7 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients With Refractory Metastatic Colorectal Cancer
n=15 participants at risk
Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
|
|---|---|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
6.7%
1/15 • Number of events 1
|
|
Blood and lymphatic system disorders
Amylase
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Ascites (non-malignant)
|
6.7%
1/15 • Number of events 1
|
|
Renal and urinary disorders
Bilirubin (hyperbilirubinemia)
|
13.3%
2/15 • Number of events 2
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Lipase
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Nausea
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Neurology - Other (specify)
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Obstruction, GI- Colon
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Obstruction, GI- Small bowel NOS
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Pain - Abdomen NOS
|
13.3%
2/15 • Number of events 2
|
|
General disorders
Vomiting
|
6.7%
1/15 • Number of events 1
|
Other adverse events
| Measure |
Patients With Refractory Metastatic Colorectal Cancer
n=15 participants at risk
Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
|
|---|---|
|
Blood and lymphatic system disorders
ALT, SGPT
|
46.7%
7/15 • Number of events 7
|
|
Blood and lymphatic system disorders
AST, SGOT
|
60.0%
9/15 • Number of events 9
|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
40.0%
6/15 • Number of events 6
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
66.7%
10/15 • Number of events 10
|
|
General disorders
Allergy reaction (including drug fever)
|
6.7%
1/15 • Number of events 2
|
|
Blood and lymphatic system disorders
Amylase
|
26.7%
4/15 • Number of events 4
|
|
Psychiatric disorders
Anorexia
|
20.0%
3/15 • Number of events 4
|
|
General disorders
Ascites (non-malignant)
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
40.0%
6/15 • Number of events 6
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Constitutional Symptoms
|
13.3%
2/15 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Dental: dentures or prosthesis
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
9/15 • Number of events 14
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
13.3%
2/15 • Number of events 2
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
60.0%
9/15 • Number of events 12
|
|
General disorders
Fever (in the absence of neutropenia)
|
13.3%
2/15 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal, other
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
46.7%
7/15 • Number of events 7
|
|
Blood and lymphatic system disorders
Hemoglobin
|
33.3%
5/15 • Number of events 5
|
|
Blood and lymphatic system disorders
INR
|
13.3%
2/15 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
20.0%
3/15 • Number of events 3
|
|
Metabolism and nutrition disorders
Lipase
|
26.7%
4/15 • Number of events 4
|
|
Blood and lymphatic system disorders
Lymphopenia
|
40.0%
6/15 • Number of events 6
|
|
Metabolism and nutrition disorders
Magnesium, low (hypomagnesemia)
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolic/Lab
|
13.3%
2/15 • Number of events 2
|
|
General disorders
Nausea
|
26.7%
4/15 • Number of events 4
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
20.0%
3/15 • Number of events 3
|
|
Gastrointestinal disorders
Obstruction, GI- Small bowel NOS
|
6.7%
1/15 • Number of events 1
|
|
Blood and lymphatic system disorders
PTT
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Pain - Abdomen NOS
|
26.7%
4/15 • Number of events 4
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
33.3%
5/15 • Number of events 5
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
20.0%
3/15 • Number of events 3
|
|
General disorders
Sweating (diaphoresis)
|
6.7%
1/15 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Vomiting
|
13.3%
2/15 • Number of events 2
|
Additional Information
Dr. Andrea Cercek
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4189
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place