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
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage IV Pancreatic Cancer||Drug: STA-9090 Radiation: Radiologic imaging Procedure: blood draw||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer|
|Study Start Date :||December 2010|
|Primary Completion Date :||May 2013|
|Study Completion Date :||May 2013|
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.
Given IVRadiation: Radiologic imaging
radiologic modalities used to evaluate response to treatment
Other Names:Procedure: blood draw
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 [ Time Frame: at 8 weeks from the start of therapy ]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.
- Best Response [ Time Frame: On-treatment date, to date of disease progression (assessed up to 1 year) ]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.
- Overall Survival [ Time Frame: study entry to date of death or last date known alive (assessed over 2.5 yrs) ]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)
- Number of Patients With Each Worst Grade Toxicity [ Time Frame: On study date to 30 days following final dose of study drug ]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
- Biomarker Evaluation [ Time Frame: Pre-treatment and 1 week post-treatment ]Serum will be tested for biomarkers that may be predictive of response, optional per patient consent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01227018
|United States, Tennessee|
|The Jones Clinic|
|Memphis, Tennessee, United States, 38138|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Dana Cardin, MD||Vanderbilt-Ingram Cancer Center|