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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-02123 |
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interim analysis found the study drug to be ineffective
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Heat shock protein (HSP)90 inhibitor STA-9090 may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. PURPOSE: This phase II trial is studying how well hsp90 inhibitor STA-9090 works as second- or third-line therapy for the treatment of patients with metastatic pancreatic cancer.
PRIMARY OBJECTIVES: I. To measure the 8-week disease control (CR + PR + SD) rate of therapy with STA-9090 in patients with metastatic pancreas cancer who have failed (either progressed or did not tolerate) one or two lines of prior therapy. SECONDARY OBJECTIVES: I. To determine response rate (by RECIST criteria v1.1). II. To determine overall survival. III. To evaluate the safety and toxicity profile in this patient population. TERTIARY OBJECTIVES: I. We will obtain from all patients blood samples pre and post therapy (after 1 week of therapy) and isolate serum for interrogation for a variety of biomarkers (eg AKT, Stat3, Caspase 3). OUTLINE: Patients receive Hsp90 inhibitor STA-9090 intravenous (IV) over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STA-9090 | Experimental | Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STA-9090 | Drug | Given IV |
| |
| Radiologic imaging |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate | 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. | at 8 weeks from the start of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Best 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker Evaluation | Serum will be tested for biomarkers that may be predictive of response, optional per patient consent. | Pre-treatment and 1 week post-treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dana Cardin, MD | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Jones Clinic | Memphis | Tennessee | 38138 | United States | ||
| Vanderbilt-Ingram Cancer Center |
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| Label | URL |
|---|---|
| Vanderbilt-Ingram Cancer Center, Find a Clinical Trial | View source |
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Seventeen patients consented to this study, 2 were determined ineligible to participate
This study opened in December 2010 and ran to April 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Disease Control Rate | 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. | Patients who received treatment and who were available for determination of response. | Posted | Number | percentage of participants | at 8 weeks from the start of therapy |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | STA-9090 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dana Cardin | Vanderbilt-Ingram Cancer Center | 615-936-8580 | dana.cardin@vanderbilt.edu |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C533237 | STA 9090 |
| D019047 | Phantoms, Imaging |
| D009682 | Magnetic Resonance Spectroscopy |
| D014965 | X-Rays |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Radiation |
radiologic modalities used to evaluate response to treatment |
|
|
| blood draw | Procedure | Venous blood will be drawn from those patients who give consent. Serum will be used to look for biomarkers predictive of response |
|
| On-treatment date, to date of disease progression (assessed up to 1 year) |
| Overall Survival | 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) | study entry to date of death or last date known alive (assessed over 2.5 yrs) |
| Number of Patients With Each Worst Grade Toxicity | 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 | On study date to 30 days following final dose of study drug |
| Nashville |
| Tennessee |
| 37232-6838 |
| United States |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Best 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. | 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. | Posted | Number | participants | On-treatment date, to date of disease progression (assessed up to 1 year) |
|
|
|
| Secondary | Overall Survival | 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) | 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. | Posted | Median | 95% Confidence Interval | days | study entry to date of death or last date known alive (assessed over 2.5 yrs) |
|
|
|
| Secondary | Number of Patients With Each Worst Grade Toxicity | 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 | 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. | Posted | Number | participants | On study date to 30 days following final dose of study drug |
|
|
|
| Other Pre-specified | Biomarker Evaluation | Serum will be tested for biomarkers that may be predictive of response, optional per patient consent. | The study's interim analysis found the study drug to be ineffective. The study was terminated. No biomarkers were performed or analyzed. | Posted | Pre-treatment and 1 week post-treatment |
|
|
| 9 |
| 14 |
| 13 |
| 14 |
| acute kidney injury | Renal and urinary disorders |
|
| alanine aminotransferase increased | Investigations |
|
| alkaline phosphatase increased | Investigations |
|
| ascites | Gastrointestinal disorders |
|
| aspartate aminotransferase increased | Investigations |
|
| biliary tract infection-cholangitis | Hepatobiliary disorders |
|
| chills | General disorders |
|
| confusion | Psychiatric disorders |
|
| dehydration | Metabolism and nutrition disorders |
|
| dyspnea | Reproductive system and breast disorders |
|
| failure to thrive | General disorders |
|
| gastric perforation | Gastrointestinal disorders |
|
| hepatic failure | Hepatobiliary disorders |
|
| hyperkalemia | Metabolism and nutrition disorders |
|
| hypokalemia | Metabolism and nutrition disorders |
|
| hyponatremia | Metabolism and nutrition disorders |
|
| lung infection | Respiratory, thoracic and mediastinal disorders |
|
| malaise | General disorders |
|
| nausea | Gastrointestinal disorders |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders |
|
| renal calculi | Renal and urinary disorders |
|
| thromboembolic event | Vascular disorders |
|
| urinary tract infection | Renal and urinary disorders |
|
| vomiting | Gastrointestinal disorders |
|
| blood bilirubin increased | Hepatobiliary disorders |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders |
|
| hypotension | Vascular disorders |
|
| diarrhea | Gastrointestinal disorders |
|
| constipation | Gastrointestinal disorders |
|
| nausea | Gastrointestinal disorders |
|
| vomiting | Gastrointestinal disorders |
|
| flatulence | Gastrointestinal disorders |
|
| gastrointestinal disorders-other | Gastrointestinal disorders |
|
| ascites | Gastrointestinal disorders |
|
| bloating | Gastrointestinal disorders |
|
| dyspepsia | Gastrointestinal disorders |
|
| esophageal pain | Gastrointestinal disorders |
|
| hemorrhoids | Gastrointestinal disorders |
|
| rectal hemorrhage | Gastrointestinal disorders |
|
| hyponatremia | Metabolism and nutrition disorders |
|
| hypokalemia | Metabolism and nutrition disorders |
|
| anorexia | Metabolism and nutrition disorders |
|
| dehydration | Metabolism and nutrition disorders |
|
| hyperglycemia | Metabolism and nutrition disorders |
|
| hypoalbuminemia | Metabolism and nutrition disorders |
|
| hypocalcemia | Metabolism and nutrition disorders |
|
| hyperkalemia | Metabolism and nutrition disorders |
|
| hypomagnesemia | Metabolism and nutrition disorders |
|
| metabolism and nutrition disorders-other | Metabolism and nutrition disorders |
|
| alkaline phosphatase increased | Investigations |
|
| alanine aminotransferase increased | Investigations |
|
| aspartate aminotransferase increased | Investigations |
|
| lymphocyte count decreased | Blood and lymphatic system disorders |
|
| blood bilirubin increased | Hepatobiliary disorders |
|
| platelet count decreased | Blood and lymphatic system disorders |
|
| weight loss | Metabolism and nutrition disorders |
|
| creatinine increased | Investigations |
|
| fatigue | General disorders |
|
| edema limbs | General disorders |
|
| pain | General disorders |
|
| chills | General disorders |
|
| edema face | General disorders |
|
| general disorders-other | General disorders |
|
| anemia | Blood and lymphatic system disorders |
|
| blood and lymphatic system disorders-other | Blood and lymphatic system disorders |
|
| dysgeusia | Nervous system disorders |
|
| headache | Nervous system disorders |
|
| dizziness | Nervous system disorders |
|
| nervous system disorders-other | Nervous system disorders |
|
| paresthesia | Nervous system disorders |
|
| peripheral sensory neuropathy | Nervous system disorders |
|
| tremor | Nervous system disorders |
|
| depression | Psychiatric disorders |
|
| insomnia | Psychiatric disorders |
|
| confusion | Psychiatric disorders |
|
| psychosis | Psychiatric disorders |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| hoarseness | Respiratory, thoracic and mediastinal disorders |
|
| laryngeal inflammation | Respiratory, thoracic and mediastinal disorders |
|
| sleep apnea | Respiratory, thoracic and mediastinal disorders |
|
| back pain | Musculoskeletal and connective tissue disorders |
|
| musculoskeletal and connective tissue disorder-other | Musculoskeletal and connective tissue disorders |
|
| pain-extremity | Musculoskeletal and connective tissue disorders |
|
| cardiac disorder-other | Cardiac disorders |
|
| sinus bradycardia | Cardiac disorders |
|
| sinus tachycardia | Cardiac disorders |
|
| bruising | Injury, poisoning and procedural complications |
|
| fall | Injury, poisoning and procedural complications |
|
| renal and urinary disorder-other | Renal and urinary disorders |
|
| urinary frequency | Renal and urinary disorders |
|
| dry skin | Skin and subcutaneous tissue disorders |
|
| rash maculo-papular | Skin and subcutaneous tissue disorders |
|
| hypotension | Vascular disorders |
|
| lung infection | Respiratory, thoracic and mediastinal disorders |
|
| irritability | General disorders |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| Title | Measurements |
|---|---|
|
| Progressive disease |
|
| Not Assessed |
|
| Not Evaluable |
|
| Title | Measurements |
|---|---|
|
| Patients with worst grade toxicity 4 |
|
| Patients with worst grade toxicity 5 |
|