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

NCT01273896 | Completed Phase 2 Results

• 1 other identifier: 10-145
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Breast Cancer

Keywords

STA-9090; advanced breast cancer; 10-145

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

STA-9090

EXPERIMENTAL

This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.

Drug: STA-9090

Interventions

STA-9090 DRUG

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.

STA-9090

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Synta Pharmaceuticals Corp.: collaborator

Study Sites (5)

Memorial Sloan-Kettering at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan-Kettering Cancer Center at Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan-Kettering Cancer Center at Mercy Medical Center

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

Sleepy Hollow, New York, 10591, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

STA 9090

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Modi, Shanu/Medicine (Assistant Attending)
• Organization: Memorial Sloan Kettering Cancer Center

modis@mskcc.org

+1646-888-4564

Study Officials

• Shanu Modi, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2011
• First Posted: January 11, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 20, 2015
• Results First Posted: November 20, 2015

Record last verified: 2015-10

Locations

US (5)