STA-9090 in Patients With Advanced Hepatocellular Cancer
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Purpose
STA-9090 works by inhibiting the function of a protein in tumor cells called Hsp90. Hsp90 is thought to play a role in tumor growth. By interfering with this protein's function, STA-9090 may help kill tumor cells. This drug has been used in other research studies and information from those studies suggests that this agent may help to slow tumor growth in HCC.
The purpose of this research study is to find the highest dose of STA-9090 that can safely be given to participants with advanced HCC. The investigators will also get more information about the safety of STA-9090 and perform tests to learn more about how STA-9090 affects the body.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma |
Drug: STA-9090 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of STA-9090 in Patients With Advanced Hepatocellular Carcinoma |
- To determine the Phase 2 dose of STA 9090 given once weekly in patients with advanced hepatocellular carcinoma [ Time Frame: 2-3 years ] [ Designated as safety issue: Yes ]Dose escalation/de-escalation study will be performed in order to determine the Phase 2 dose of STA-9090 given once weekly in patients with advanced hepatocellular carcinoma. The dose limiting toxicities will be determined at each dose level.
- To assess the safety and toxicity of STA 9090 in patients with advanced hepatocellular carcinoma [ Time Frame: 2-3 years ] [ Designated as safety issue: Yes ]To assess the pharmacokinetics of STA-9090 when administered as a short-term intravenous infusion in patients with hepatocellular carcinoma; To determine the response rate, TTP/PFS and OS of this cohort treated with STA-9090.
- Median time to progression (TTP) [ Time Frame: average of 2- 3 years ] [ Designated as safety issue: Yes ]To determine median time to progression (TTP) for patients treated at recommended Phase 2 dose.
- Median progression-free survival (PFS) [ Time Frame: average of 2-3 years ] [ Designated as safety issue: Yes ]To determine median progression-free survival (PFS) for patients treated at recommended Phase 2 dose.
- Response Rate [ Time Frame: average of 2-3 years ] [ Designated as safety issue: Yes ]To determine objective tumor response rate using RECIST criteria
- Overall Survival [ Time Frame: average of 2-3 years ] [ Designated as safety issue: No ]To determine overall survival
| Estimated Enrollment: | 32 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: STA-9090
Patients receiving STA-9090
|
Drug: STA-9090
IV one time weekly for 3 weeks in 4 week cycles. Study treatment is given in 4-week time periods called cycles. Patients will receive STA-9090 for the first 3 weeks of each cycle and no treatment on the fourth week. STA-9090 will be given by intravenous (IV) infusion. IV infusions occur through an IV catheter (or tube) placed in the vein. Each infusion will last about 60 minutes. During each cycles patients will have blood tests, pregnancy test, and EKG. Twenty to thirty days after the last dose, patients will return for a physical exam, blood tests, urine test, EKG, and CT or MRI of chest and abdomen. |
Detailed Description:
Study treatment is given in 4-week time periods called cycles. Patients will receive ST-9090 for the first 3 weeks of each cycle and no treatment on the fourth week. STA-9090 will be given by intravenous (IV) infusion. IV infusions occur through an IV catheter (or tube) placed in the vein. Each infusion will last about 60 minutes.
During each cycles patients will have blood tests, pregnancy test, and EKG. Twenty to thirty days after the last dose, patients will return for a physical exam, blood tests, urine test, EKG, and CT or MRI of chest and abdomen.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed hepatocellular carcinoma
- Measurable disease
- Life expectancy greater than 3 months
- ECOG performance status 0 or 1
- BCLC Stage C disease
- Lab values must be within limits outlined in protocol
- Child-Pugh score </= 6
- CLIP score 0-3
- Must agree to use adequate contraception
Exclusion Criteria:
- Chemotherapy or radiotherapy within 4 weeks prior to entering study or not recovered from adverse events due to agents administered more than 4 weeks earlier
- Receiving any other investigational agent
- Known brain metastases unless treated and radiographically and clinically stable without steroid or anticonvulsant medications for at least 4 weeks prior to first dose of STA-9090
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to STA-9090
- Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease
- Major surgery within 4 weeks prior to first dose of STA-9090
- Poor venous access for study drug administration or would require a peripheral or central indwelling catheter for study drug administration
- History of severe allergic or hypersensitivity reactions to excipients (e.g., Polyethylene glycol [PE] 300 and Polysorbate 80)
- Baseline QTc > 450 msec or previous history of QT prolongation while taking other medications
- Ventricular ejection fraction </= 55% at baseline
- Treatment with chronic immunosuppressants
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breast-feeding
- History of a different malignancy unless disease-free for at least 5 years and deemed by the investigator to be at low risk for recurrence.
- HIV-positive individuals on combination antiretroviral therapy
Contacts and Locations| Contact: Andrew X Zhu, MD | 617-724-0234 | azhu@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Thomas Abrams, MD 617-632-6932 taabrams@partners.org | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Rebecca Miksad, MD 617-667-4827 rmiksad@bidmc.harvard.edu | |
More Information
No publications provided
| Responsible Party: | Andrew X. Zhu, MD, MD, PhD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01665937 History of Changes |
| Other Study ID Numbers: | 10-072 |
| Study First Received: | April 27, 2010 |
| Last Updated: | August 15, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Massachusetts General Hospital:
|
liver cancer advanced liver cancer advanced hepatocellular cancer |
Additional relevant MeSH terms:
|
Carcinoma Liver Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Adenocarcinoma |
ClinicalTrials.gov processed this record on May 23, 2013