Trials / Terminated
TerminatedNCT01227018
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Vanderbilt-Ingram Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | STA-9090 | Given IV |
| RADIATION | Radiologic imaging | radiologic modalities used to evaluate response to treatment |
| 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 |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2013-05-01
- Completion
- 2013-05-01
- First posted
- 2010-10-22
- Last updated
- 2014-07-23
- Results posted
- 2014-07-23
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01227018. Inclusion in this directory is not an endorsement.