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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: STA-9090

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01273896

10-145

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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