Clinical trialPhase 2Terminated
PhII Study STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer
Phase II Study of STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer
- Outcome
- Stopped earlyinterim analysis found the study drug to be ineffective (Efficacy or futility)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- December 2010
- Expected end
- May 2013
- Enrollment
- 15 participants
- Sites
- 2
- Primary outcomes
- Disease Control Rate
- Sponsor
- Other
- Results posted
- 2014-07-23
- Last update
- 23 July 2014
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Disease Control Rate [at 8 weeks from the start of therapy]. Number, percentage of participants. STA-9090 (n=11): 21.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Best Response [On-treatment date, to date of disease progression (assessed up to 1 year)]. Number, participants. Complete response: STA-9090 (n=15): 0. Partial response: STA-9090 (n=15): 0. Stable disease: STA-9090 (n=15): 3. Progressive disease: STA-9090 (n=15): 8. Not Assessed: STA-9090 (n=15): 3. Not Evaluable: STA-9090 (n=15): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [study entry to date of death or last date known alive (assessed over 2.5 yrs)]. Median, days (95% Confidence Interval). STA-9090 (n=15): 125 (45 to 148).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Patients With Each Worst Grade Toxicity [On study date to 30 days following final dose of study drug]. Number, participants. Patients with worst grade toxicity 1: STA-9090 (n=13): 0. Patients with worst grade toxicity 2: STA-9090 (n=13): 5. Patients with worst grade toxicity 3: STA-9090 (n=13): 8. Patients with worst grade toxicity 4: STA-9090 (n=13): 0. Patients with worst grade toxicity 5: STA-9090 (n=13): 0.