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Trial record 1 of 3 for:    HSP90 | "Pancreatic Neoplasms"
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PhII Study STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer

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ClinicalTrials.gov Identifier: NCT01227018
Recruitment Status : Terminated (interim analysis found the study drug to be ineffective)
First Posted : October 22, 2010
Results First Posted : July 23, 2014
Last Update Posted : July 23, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dana Cardin, MD, Vanderbilt-Ingram Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage IV Pancreatic Cancer
Interventions Drug: STA-9090
Radiation: Radiologic imaging
Procedure: blood draw
Enrollment 15
Recruitment Details This study opened in December 2010 and ran to April 2013
Pre-assignment Details Seventeen patients consented to this study, 2 were determined ineligible to participate
Arm/Group Title STA-9090
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 15
Completed 0
Not Completed 15
Reason Not Completed
Disease progression             9
Toxicity             2
Withdrew after beginning treatment             4
Arm/Group Title STA-9090
Hide Arm/Group Description 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 Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  60.0%
>=65 years
6
  40.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants
65
(33 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
4
  26.7%
Male
11
  73.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Disease Control Rate
Hide Description 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.
Time Frame at 8 weeks from the start of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received treatment and who were available for determination of response.
Arm/Group Title STA-9090
Hide Arm/Group Description:
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 Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: percentage of participants
21
2.Secondary Outcome
Title Best Response
Hide Description 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.
Time Frame On-treatment date, to date of disease progression (assessed up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title STA-9090
Hide Arm/Group Description:
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 Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
Complete response 0
Partial response 0
Stable disease 3
Progressive disease 8
Not Assessed 3
Not Evaluable 1
3.Secondary Outcome
Title Overall Survival
Hide Description 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)
Time Frame study entry to date of death or last date known alive (assessed over 2.5 yrs)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title STA-9090
Hide Arm/Group Description:
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 Number of Participants Analyzed 15
Median (95% Confidence Interval)
Unit of Measure: days
125
(45 to 148)
4.Secondary Outcome
Title Number of Patients With Each Worst Grade Toxicity
Hide Description 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
Time Frame On study date to 30 days following final dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title STA-9090
Hide Arm/Group Description:
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 Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
Patients with worst grade toxicity 1 0
Patients with worst grade toxicity 2 5
Patients with worst grade toxicity 3 8
Patients with worst grade toxicity 4 0
Patients with worst grade toxicity 5 0
5.Other Pre-specified Outcome
Title Biomarker Evaluation
Hide Description Serum will be tested for biomarkers that may be predictive of response, optional per patient consent.
Time Frame Pre-treatment and 1 week post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The study's interim analysis found the study drug to be ineffective. The study was terminated. No biomarkers were performed or analyzed.
Arm/Group Title STA-9090
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title STA-9090
Hide Arm/Group Description 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.
All-Cause Mortality
STA-9090
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
STA-9090
Affected / at Risk (%) # Events
Total   9/14 (64.29%)    
Gastrointestinal disorders   
Abdominal pain  3/14 (21.43%)  3
ascites  1/14 (7.14%)  1
gastric perforation  1/14 (7.14%)  1
nausea  3/14 (21.43%)  3
vomiting  2/14 (14.29%)  2
General disorders   
chills  1/14 (7.14%)  1
failure to thrive  1/14 (7.14%)  1
malaise  1/14 (7.14%)  1
Hepatobiliary disorders   
biliary tract infection-cholangitis  1/14 (7.14%)  1
hepatic failure  1/14 (7.14%)  1
blood bilirubin increased  2/14 (14.29%)  2
Investigations   
alanine aminotransferase increased  1/14 (7.14%)  1
alkaline phosphatase increased  1/14 (7.14%)  1
aspartate aminotransferase increased  1/14 (7.14%)  1
Metabolism and nutrition disorders   
dehydration  2/14 (14.29%)  2
hyperkalemia  1/14 (7.14%)  1
hypokalemia  1/14 (7.14%)  1
hyponatremia  1/14 (7.14%)  1
Psychiatric disorders   
confusion  1/14 (7.14%)  1
Renal and urinary disorders   
acute kidney injury  1/14 (7.14%)  1
renal calculi  1/14 (7.14%)  1
urinary tract infection  1/14 (7.14%)  1
Reproductive system and breast disorders   
dyspnea  1/14 (7.14%)  1
Respiratory, thoracic and mediastinal disorders   
lung infection  1/14 (7.14%)  1
pleural effusion  1/14 (7.14%)  1
Acute respiratory failure  1/14 (7.14%)  1
Vascular disorders   
thromboembolic event  1/14 (7.14%)  1
hypotension  1/14 (7.14%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
STA-9090
Affected / at Risk (%) # Events
Total   13/14 (92.86%)    
Blood and lymphatic system disorders   
lymphocyte count decreased  5/14 (35.71%)  8
platelet count decreased  4/14 (28.57%)  4
anemia  7/14 (50.00%)  11
blood and lymphatic system disorders-other  1/14 (7.14%)  1
Cardiac disorders   
cardiac disorder-other  1/14 (7.14%)  1
sinus bradycardia  1/14 (7.14%)  2
sinus tachycardia  1/14 (7.14%)  1
Gastrointestinal disorders   
abdominal pain  9/14 (64.29%)  16
diarrhea  8/14 (57.14%)  25
constipation  7/14 (50.00%)  10
nausea  6/14 (42.86%)  16
vomiting  3/14 (21.43%)  10
flatulence  2/14 (14.29%)  2
gastrointestinal disorders-other  2/14 (14.29%)  2
ascites  1/14 (7.14%)  1
bloating  1/14 (7.14%)  1
dyspepsia  1/14 (7.14%)  2
esophageal pain  1/14 (7.14%)  1
hemorrhoids  1/14 (7.14%)  1
rectal hemorrhage  1/14 (7.14%)  1
General disorders   
fatigue  9/14 (64.29%)  18
edema limbs  3/14 (21.43%)  4
pain  2/14 (14.29%)  2
chills  1/14 (7.14%)  1
edema face  1/14 (7.14%)  1
general disorders-other  1/14 (7.14%)  2
irritability  1/14 (7.14%)  1
Hepatobiliary disorders   
blood bilirubin increased  4/14 (28.57%)  7
Injury, poisoning and procedural complications   
bruising  1/14 (7.14%)  1
fall  1/14 (7.14%)  1
Investigations   
alkaline phosphatase increased  8/14 (57.14%)  13
alanine aminotransferase increased  6/14 (42.86%)  9
aspartate aminotransferase increased  5/14 (35.71%)  8
creatinine increased  1/14 (7.14%)  1
Metabolism and nutrition disorders   
hyponatremia  8/14 (57.14%)  16
hypokalemia  6/14 (42.86%)  8
anorexia  4/14 (28.57%)  4
dehydration  4/14 (28.57%)  4
hyperglycemia  4/14 (28.57%)  9
hypoalbuminemia  4/14 (28.57%)  10
hypocalcemia  2/14 (14.29%)  2
hyperkalemia  1/14 (7.14%)  2
hypomagnesemia  1/14 (7.14%)  1
metabolism and nutrition disorders-other  1/14 (7.14%)  2
weight loss  3/14 (21.43%)  4
Musculoskeletal and connective tissue disorders   
back pain  4/14 (28.57%)  5
musculoskeletal and connective tissue disorder-other  1/14 (7.14%)  1
pain-extremity  1/14 (7.14%)  2
Nervous system disorders   
dysgeusia  2/14 (14.29%)  2
headache  2/14 (14.29%)  2
dizziness  1/14 (7.14%)  1
nervous system disorders-other  1/14 (7.14%)  1
paresthesia  1/14 (7.14%)  1
peripheral sensory neuropathy  1/14 (7.14%)  1
tremor  1/14 (7.14%)  1
Psychiatric disorders   
depression  3/14 (21.43%)  4
insomnia  2/14 (14.29%)  3
confusion  1/14 (7.14%)  2
psychosis  1/14 (7.14%)  1
Renal and urinary disorders   
renal and urinary disorder-other  2/14 (14.29%)  3
urinary frequency  1/14 (7.14%)  1
Respiratory, thoracic and mediastinal disorders   
dyspnea  2/14 (14.29%)  2
hoarseness  1/14 (7.14%)  1
laryngeal inflammation  1/14 (7.14%)  1
sleep apnea  1/14 (7.14%)  1
lung infection  1/14 (7.14%)  1
Skin and subcutaneous tissue disorders   
dry skin  1/14 (7.14%)  1
rash maculo-papular  1/14 (7.14%)  1
Vascular disorders   
hypotension  2/14 (14.29%)  2
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Dana Cardin
Organization: Vanderbilt-Ingram Cancer Center
Phone: 615-936-8580
EMail: dana.cardin@vanderbilt.edu
Layout table for additonal information
Responsible Party: Dana Cardin, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01227018    
Other Study ID Numbers: VICC GI 1016
NCI-2010-02123
First Submitted: October 20, 2010
First Posted: October 22, 2010
Results First Submitted: June 23, 2014
Results First Posted: July 23, 2014
Last Update Posted: July 23, 2014