STA-9090 in Patients With Advanced Hepatocellular Cancer

This study has been completed.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Synta Pharmaceuticals Corp.
Information provided by (Responsible Party):
Andrew X. Zhu, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01665937
First received: April 27, 2010
Last updated: March 19, 2014
Last verified: March 2014
  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: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Phase 2 dose of STA 9090 given once weekly in patients with advanced hepatocellular carcinoma [ Time Frame: 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.


Secondary Outcome Measures:
  • Number of patients with adverse events when treated with STA 9090 for advanced hepatocellular carcinoma [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of STA9090 in patients with advanced hepatocellular carcinoma.

  • Median time to progression (TTP) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To determine median time to progression (TTP) for patients treated at recommended Phase 2 dose.

  • Median progression-free survival (PFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To determine median progression-free survival (PFS) for patients treated at recommended Phase 2 dose.

  • Response Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To determine objective tumor response rate using RECIST criteria

  • Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To determine overall survival


Enrollment: 16
Study Start Date: August 2010
Study Completion Date: March 2014
Primary Completion Date: July 2013 (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 once weekly 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665937

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Synta Pharmaceuticals Corp.
  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: March 19, 2014
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 September 14, 2014