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

Breast Cancer Clinical Trial

Official title:

A Phase 2 Open-label Study of STA-9090 for Patients With Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01273896
• Other study ID #: 10-145
• Status: Completed
• Phase: Phase 2
• First received: January 6, 2011
• Last updated: October 19, 2015
• Start date: January 2011
• Est. completion date: September 2013

Study information

• Verified date: October 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering at Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan-Kettering Cancer Center at Commack	Commack	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan-Kettering Cancer Center at Mercy Medical Center	Rockville Centre	New York
United States	Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center	Sleepy Hollow	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Synta Pharmaceuticals Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate	To determine the overall response rate using RECIST v 1.1 criteria, defined as PR +CR.using RECIST v 1.1 criteria, defined as Partial response + complete response	Radiological imaging studies to evaluate tumor status will be repeated during the rest week (Days 22 to 28) of every third cycle	No

External Links

•   Memorial Sloan-Kettering Cancer Center