Open-label Study of STA-9090 for Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Synta Pharmaceuticals Corp.
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01273896
First received: January 6, 2011
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to find out what effects, good and/or bad, STA-9090 has on the patient and their breast cancer.

STA-9090 is an experimental drug that works by breaking down cancer proteins. When the cancer proteins are destroyed, the cancer cells die. STA-9090 is an experimental drug that is not yet approved for the treatment of cancer by the United States (FDA) Food and Drug Administration . STA-9090 has been tested in cancer patients in other trials and a safe dose for this drug has been found. We are now interested to see how active this drug is against breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: STA-9090
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Open-label Study of STA-9090 for Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To determine the overall response rate using RECIST v 1.1 criteria, defined as Partial response + complete response [ Time Frame: Radiological imaging studies to evaluate tumor status will be repeated during the rest week (Days 22 to 28) of every third cycle ] [ Designated as safety issue: No ]
    using RECIST v 1.1 criteria, defined as Partial response + complete response


Secondary Outcome Measures:
  • To determine the duration of response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To further characterize the safety profile of STA-9090 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    AEs will be defined based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.

  • To determine the clinical benefit rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    defined as CR+PR+ SD ≥6 months

  • To determine progression free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Median PFS and overall survival will be estimated by the Kaplan-Meier method.

  • To determine time to response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To determine overall survival. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Median PFS and overall survival will be estimated by the Kaplan-Meier method. Subject survival information will be collected every 12 weeks (± 1 week) from the date of last dose of study drug until the subject's death or until the subject is lost to follow-up, or until study closure.


Enrollment: 22
Study Start Date: January 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STA-9090
This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.
Drug: STA-9090
All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and Female patients must be at least 18 years of age
  • Pathologically confirmed diagnosis of breast cancer
  • Metastatic or advanced stage breast cancer
  • Prior treatment with at least one and no more than three lines of biologic and/or chemotherapy for metastatic breast cancer (excluding hormonal therapy)
  • Patients with HER2+ disease must have received prior treatment with Trastuzumab
  • Patients with ER and/or PR+ disease must have received prior treatment with hormonal therapy
  • Off cytotoxic chemotherapy or biologic therapy (excluding Hormonal therapy) ≥ 3 weeks
  • Measurable disease by RECIST 1.1
  • Central nervous system metastases are permitted if treated and radiographically and clinically stable for at least 4 weeks prior to first dose of STA-9090
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  • Life expectancy of at least 3 months
  • Adequate hematologic function as defined by:
  • Absolute neutrophil count ≥1,500 cells/μL
  • Platelets ≥100,000/μL
  • Hemoglobin ≥ 9.0g/dL
  • Adequate hepatic function as defined by:
  • Serum bilirubin ≤ 1.5 X upper limit of normal (ULN);
  • Adequate renal function as defined by a serum creatinine ≤ 1.5 x ULN
  • AST, ALT, and alkaline phosphatase ≤ 3 × ULN except for:
  • Patients with hepatic metastases: ALT and AST ≤ 5 × ULN
  • Patients with hepatic and/or bone metastases: alkaline phosphatase ≤ 5 × ULN
  • Patients with Gilbert's disease: serum bilirubin < 5 mg/dL
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
  • Female subjects of childbearing potential and males must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment
  • Female subjects of childbearing age must have a negative serum pregnancy test at study entry.

Exclusion Criteria:

  • 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 peripheral venous access for study drug administration. Study drug administration via indwelling catheters allowed only if the catheter is made of silicone material.
  • History of severe (grade 3 or 4) allergic or hypersensitivity reactions to excipients (e.g., Polyethylene glycol [PEG] 300 and Polysorbate 80)
  • Baseline QTc > 470 msec
  • Ventricular ejection fraction (EF) <50% at baseline
  • Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)
  • Women who are pregnant or lactating
  • Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results in the judgment of the investigator
  • Seizure disorder or requirement for seizure medication
  • Prior treatment with an HSP90 inhibitor
  • persistent adverse events of prior therapies that are > 1 grade 1 in severity
  • history of or current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass surgery
  • history of or current uncontrolled dysrhythmias, or requirement for antiarrhythmic medications, or Grade 2 or greater left bundle branch block
  • New York Heart Association class II/III/IV congestive heart failure with a history of dyspnea, orthopnea, or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta blockers or diuretics
  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: NCT01273896

Locations
United States, New Jersey
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
United States, New York
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, United States, 11570
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, United States, 10591
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Synta Pharmaceuticals Corp.
Investigators
Principal Investigator: Shanu Modi, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01273896     History of Changes
Other Study ID Numbers: 10-145
Study First Received: January 6, 2011
Last Updated: September 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
STA-9090
advanced breast cancer
10-145

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 27, 2014