A Phase 2 interventional study of STA-9090 and Radiologic imaging in Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer and Stage IV Pancreatic Cancer, sponsored by Vanderbilt-Ingram Cancer Center. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-23.
Sponsored by Vanderbilt-Ingram Cancer Center · Phase 2, Interventional, and Treatment
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 15 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Vanderbilt-Ingram Cancer Center is the lead sponsor of 220 studies on the registry; 32 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
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Exclusion Criteria:
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.
Drug: STA-9090 · Radiation: Radiologic imaging · Procedure: blood draw
Given IV
radiologic modalities used to evaluate response to treatment
Also known as: computerized tomographic (CT) scan, magnetic resonance imaging (MRI), chest x-ray
Venous blood will be drawn from those patients who give consent. Serum will be used to look for biomarkers predictive of response
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.
Time frame: at 8 weeks from the start of therapy
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.
Time frame: 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)
Time frame: 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
Time frame: On study date to 30 days following final dose of study drug
Biomarker Evaluation
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
This study opened in December 2010 and ran to April 2013
| Milestone | STA-9090 |
|---|---|
| Started | 15 |
| Completed | 0 |
| Not completed | 15 |
| Withdrew: Disease progression | 9 |
| Withdrew: Toxicity | 2 |
| Withdrew: Withdrew after beginning treatment | 4 |
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.
| percentage of participants | STA-9090 |
|---|---|
| Disease Control Rate | 21 |
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.
| participants | STA-9090 |
|---|---|
| Complete response | 0 |
| Partial response | 0 |
| Stable disease | 3 |
| Progressive disease | 8 |
| Not Assessed | 3 |
| Not Evaluable | 1 |
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)
| days | STA-9090 |
|---|---|
| Overall Survival | 125 (45 to 148) |
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
| participants | STA-9090 |
|---|---|
| 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 |
Serum will be tested for biomarkers that may be predictive of response, optional per patient consent.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| STA-9090 | — | 9/14 (64.3%) | 13/14 (92.9%) |
| Event | STA-9090 |
|---|---|
| Abdominal painGastrointestinal disorders | 3/14 |
| nauseaGastrointestinal disorders | 3/14 |
| dehydrationMetabolism and nutrition disorders | 2/14 |
| vomitingGastrointestinal disorders | 2/14 |
| blood bilirubin increasedHepatobiliary disorders | 2/14 |
| acute kidney injuryRenal and urinary disorders | 1/14 |
| alanine aminotransferase increasedInvestigations | 1/14 |
| alkaline phosphatase increasedInvestigations | 1/14 |
| ascitesGastrointestinal disorders | 1/14 |
| aspartate aminotransferase increasedInvestigations | 1/14 |
| Event | STA-9090 |
|---|---|
| abdominal painGastrointestinal disorders | 9/14 |
| fatigueGeneral disorders | 9/14 |
| diarrheaGastrointestinal disorders | 8/14 |
| hyponatremiaMetabolism and nutrition disorders | 8/14 |
| alkaline phosphatase increasedInvestigations | 8/14 |
| constipationGastrointestinal disorders | 7/14 |
| anemiaBlood and lymphatic system disorders | 7/14 |
| nauseaGastrointestinal disorders | 6/14 |
| hypokalemiaMetabolism and nutrition disorders | 6/14 |
| alanine aminotransferase increasedInvestigations | 6/14 |
| Age, Categorical(Participants) | STA-9090 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 9 |
| >=65 years | 6 |
| Age, Continuous(years) | STA-9090 |
|---|---|
| Median | 65 ± 11 |
| Sex: Female, Male(Participants) | STA-9090 |
|---|---|
| Female | 4 |
| Male | 11 |
| Region of Enrollment(participants) | STA-9090 |
|---|---|
| United States | 15 |
This study is terminated, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Vanderbilt-Ingram Cancer Center