Trial Outcomes & Findings for PhII Study STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer (NCT NCT01227018)
NCT ID: NCT01227018
Last Updated: 2014-07-23
Results Overview
Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions, and progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions. Disease control is defined as CR + PR + SD after 8 weeks of therapy.
TERMINATED
PHASE2
15 participants
at 8 weeks from the start of therapy
2014-07-23
Participant Flow
This study opened in December 2010 and ran to April 2013
Seventeen patients consented to this study, 2 were determined ineligible to participate
Participant milestones
| Measure |
STA-9090
175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
STA-9090
175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Disease progression
|
9
|
|
Overall Study
Toxicity
|
2
|
|
Overall Study
Withdrew after beginning treatment
|
4
|
Baseline Characteristics
PhII Study STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer
Baseline characteristics by cohort
| Measure |
STA-9090
n=15 Participants
175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
FULL_RANGE 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 8 weeks from the start of therapyPopulation: Patients who received treatment and who were available for determination of response.
Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions, and progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions. Disease control is defined as CR + PR + SD after 8 weeks of therapy.
Outcome measures
| Measure |
STA-9090
n=11 Participants
175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
|
|---|---|
|
Disease Control Rate
|
21 percentage of participants
|
SECONDARY outcome
Timeframe: On-treatment date, to date of disease progression (assessed up to 1 year)Population: All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is non-evaluable for best overall response.
Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), \>=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), \>=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR\>PR\>SD\>PD.
Outcome measures
| Measure |
STA-9090
n=15 Participants
175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
|
|---|---|
|
Best Response
Complete response
|
0 participants
|
|
Best Response
Partial response
|
0 participants
|
|
Best Response
Stable disease
|
3 participants
|
|
Best Response
Progressive disease
|
8 participants
|
|
Best Response
Not Assessed
|
3 participants
|
|
Best Response
Not Evaluable
|
1 participants
|
SECONDARY outcome
Timeframe: study entry to date of death or last date known alive (assessed over 2.5 yrs)Population: All patients are included in the analysis on intention-totreat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date.
Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details)
Outcome measures
| Measure |
STA-9090
n=15 Participants
175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
125 days
Interval 45.0 to 148.0
|
SECONDARY outcome
Timeframe: On study date to 30 days following final dose of study drugPopulation: Total number of patients reported with any toxicity related to study treatment. One patient withdrew before treatment. One patient did not have a toxicity related to study drug or therapy.
Count of patients according to the worst-grade toxicity experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life-threatening; grade 5, death
Outcome measures
| Measure |
STA-9090
n=13 Participants
175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Patients With Each Worst Grade Toxicity
Patients with worst grade toxicity 1
|
0 participants
|
|
Number of Patients With Each Worst Grade Toxicity
Patients with worst grade toxicity 2
|
5 participants
|
|
Number of Patients With Each Worst Grade Toxicity
Patients with worst grade toxicity 3
|
8 participants
|
|
Number of Patients With Each Worst Grade Toxicity
Patients with worst grade toxicity 4
|
0 participants
|
|
Number of Patients With Each Worst Grade Toxicity
Patients with worst grade toxicity 5
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatment and 1 week post-treatmentPopulation: The study's interim analysis found the study drug to be ineffective. The study was terminated. No biomarkers were performed or analyzed.
Serum will be tested for biomarkers that may be predictive of response, optional per patient consent.
Outcome measures
Outcome data not reported
Adverse Events
STA-9090
Serious adverse events
| Measure |
STA-9090
n=14 participants at risk
175 mg/m2 STA-9090 IV over 1 hour once a week for 3 weeks, followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
21.4%
3/14 • Number of events 3
|
|
Renal and urinary disorders
acute kidney injury
|
7.1%
1/14 • Number of events 1
|
|
Investigations
alanine aminotransferase increased
|
7.1%
1/14 • Number of events 1
|
|
Investigations
alkaline phosphatase increased
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
ascites
|
7.1%
1/14 • Number of events 1
|
|
Investigations
aspartate aminotransferase increased
|
7.1%
1/14 • Number of events 1
|
|
Hepatobiliary disorders
biliary tract infection-cholangitis
|
7.1%
1/14 • Number of events 1
|
|
General disorders
chills
|
7.1%
1/14 • Number of events 1
|
|
Psychiatric disorders
confusion
|
7.1%
1/14 • Number of events 1
|
|
Metabolism and nutrition disorders
dehydration
|
14.3%
2/14 • Number of events 2
|
|
Reproductive system and breast disorders
dyspnea
|
7.1%
1/14 • Number of events 1
|
|
General disorders
failure to thrive
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
gastric perforation
|
7.1%
1/14 • Number of events 1
|
|
Hepatobiliary disorders
hepatic failure
|
7.1%
1/14 • Number of events 1
|
|
Metabolism and nutrition disorders
hyperkalemia
|
7.1%
1/14 • Number of events 1
|
|
Metabolism and nutrition disorders
hypokalemia
|
7.1%
1/14 • Number of events 1
|
|
Metabolism and nutrition disorders
hyponatremia
|
7.1%
1/14 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
lung infection
|
7.1%
1/14 • Number of events 1
|
|
General disorders
malaise
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
nausea
|
21.4%
3/14 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
7.1%
1/14 • Number of events 1
|
|
Renal and urinary disorders
renal calculi
|
7.1%
1/14 • Number of events 1
|
|
Vascular disorders
thromboembolic event
|
7.1%
1/14 • Number of events 1
|
|
Renal and urinary disorders
urinary tract infection
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
vomiting
|
14.3%
2/14 • Number of events 2
|
|
Hepatobiliary disorders
blood bilirubin increased
|
14.3%
2/14 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
7.1%
1/14 • Number of events 1
|
|
Vascular disorders
hypotension
|
7.1%
1/14 • Number of events 1
|
Other adverse events
| Measure |
STA-9090
n=14 participants at risk
175 mg/m2 STA-9090 IV over 1 hour once a week for 3 weeks, followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression.
|
|---|---|
|
Gastrointestinal disorders
abdominal pain
|
64.3%
9/14 • Number of events 16
|
|
Gastrointestinal disorders
diarrhea
|
57.1%
8/14 • Number of events 25
|
|
Gastrointestinal disorders
constipation
|
50.0%
7/14 • Number of events 10
|
|
Gastrointestinal disorders
nausea
|
42.9%
6/14 • Number of events 16
|
|
Gastrointestinal disorders
vomiting
|
21.4%
3/14 • Number of events 10
|
|
Gastrointestinal disorders
flatulence
|
14.3%
2/14 • Number of events 2
|
|
Gastrointestinal disorders
gastrointestinal disorders-other
|
14.3%
2/14 • Number of events 2
|
|
Gastrointestinal disorders
ascites
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
bloating
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
dyspepsia
|
7.1%
1/14 • Number of events 2
|
|
Gastrointestinal disorders
esophageal pain
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
hemorrhoids
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
rectal hemorrhage
|
7.1%
1/14 • Number of events 1
|
|
Metabolism and nutrition disorders
hyponatremia
|
57.1%
8/14 • Number of events 16
|
|
Metabolism and nutrition disorders
hypokalemia
|
42.9%
6/14 • Number of events 8
|
|
Metabolism and nutrition disorders
anorexia
|
28.6%
4/14 • Number of events 4
|
|
Metabolism and nutrition disorders
dehydration
|
28.6%
4/14 • Number of events 4
|
|
Metabolism and nutrition disorders
hyperglycemia
|
28.6%
4/14 • Number of events 9
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
28.6%
4/14 • Number of events 10
|
|
Metabolism and nutrition disorders
hypocalcemia
|
14.3%
2/14 • Number of events 2
|
|
Metabolism and nutrition disorders
hyperkalemia
|
7.1%
1/14 • Number of events 2
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
7.1%
1/14 • Number of events 1
|
|
Metabolism and nutrition disorders
metabolism and nutrition disorders-other
|
7.1%
1/14 • Number of events 2
|
|
Investigations
alkaline phosphatase increased
|
57.1%
8/14 • Number of events 13
|
|
Investigations
alanine aminotransferase increased
|
42.9%
6/14 • Number of events 9
|
|
Investigations
aspartate aminotransferase increased
|
35.7%
5/14 • Number of events 8
|
|
Blood and lymphatic system disorders
lymphocyte count decreased
|
35.7%
5/14 • Number of events 8
|
|
Hepatobiliary disorders
blood bilirubin increased
|
28.6%
4/14 • Number of events 7
|
|
Blood and lymphatic system disorders
platelet count decreased
|
28.6%
4/14 • Number of events 4
|
|
Metabolism and nutrition disorders
weight loss
|
21.4%
3/14 • Number of events 4
|
|
Investigations
creatinine increased
|
7.1%
1/14 • Number of events 1
|
|
General disorders
fatigue
|
64.3%
9/14 • Number of events 18
|
|
General disorders
edema limbs
|
21.4%
3/14 • Number of events 4
|
|
General disorders
pain
|
14.3%
2/14 • Number of events 2
|
|
General disorders
chills
|
7.1%
1/14 • Number of events 1
|
|
General disorders
edema face
|
7.1%
1/14 • Number of events 1
|
|
General disorders
general disorders-other
|
7.1%
1/14 • Number of events 2
|
|
Blood and lymphatic system disorders
anemia
|
50.0%
7/14 • Number of events 11
|
|
Blood and lymphatic system disorders
blood and lymphatic system disorders-other
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
dysgeusia
|
14.3%
2/14 • Number of events 2
|
|
Nervous system disorders
headache
|
14.3%
2/14 • Number of events 2
|
|
Nervous system disorders
dizziness
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
nervous system disorders-other
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
paresthesia
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
peripheral sensory neuropathy
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
tremor
|
7.1%
1/14 • Number of events 1
|
|
Psychiatric disorders
depression
|
21.4%
3/14 • Number of events 4
|
|
Psychiatric disorders
insomnia
|
14.3%
2/14 • Number of events 3
|
|
Psychiatric disorders
confusion
|
7.1%
1/14 • Number of events 2
|
|
Psychiatric disorders
psychosis
|
7.1%
1/14 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
14.3%
2/14 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
hoarseness
|
7.1%
1/14 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
laryngeal inflammation
|
7.1%
1/14 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
sleep apnea
|
7.1%
1/14 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
back pain
|
28.6%
4/14 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal and connective tissue disorder-other
|
7.1%
1/14 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
pain-extremity
|
7.1%
1/14 • Number of events 2
|
|
Cardiac disorders
cardiac disorder-other
|
7.1%
1/14 • Number of events 1
|
|
Cardiac disorders
sinus bradycardia
|
7.1%
1/14 • Number of events 2
|
|
Cardiac disorders
sinus tachycardia
|
7.1%
1/14 • Number of events 1
|
|
Injury, poisoning and procedural complications
bruising
|
7.1%
1/14 • Number of events 1
|
|
Injury, poisoning and procedural complications
fall
|
7.1%
1/14 • Number of events 1
|
|
Renal and urinary disorders
renal and urinary disorder-other
|
14.3%
2/14 • Number of events 3
|
|
Renal and urinary disorders
urinary frequency
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
dry skin
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
7.1%
1/14 • Number of events 1
|
|
Vascular disorders
hypotension
|
14.3%
2/14 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
lung infection
|
7.1%
1/14 • Number of events 1
|
|
General disorders
irritability
|
7.1%
1/14 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place