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

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01273896
• Collaborator: Synta Pharmaceuticals Corp. (Industry)
• Enrollment: 22
• Locations: 5
• Arm: 1
• Duration (Months): 32
• Patients Per Site: 4.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: STA-9090	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Open-label Study of STA-9090 for Patients With Metastatic Breast Cancer
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Overall Response Rate [Radiological imaging studies to evaluate tumor status will be repeated during the rest week (Days 22 to 28) of every third cycle]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan-Kettering at Basking Ridge	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan-Kettering Cancer Center at Commack	Commack	New York	United States	11725
3	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
4	Memorial Sloan-Kettering Cancer Center at Mercy Medical Center	Rockville Centre	New York	United States	11570
5	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan-Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT01273896
• Other Study ID Numbers: 10-145
• First Posted: Jan 11, 2011
• Last Update Posted: Nov 20, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by Memorial Sloan Kettering Cancer Center: STA-9090; advanced breast cancer; 10-145
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

Participant Flow

Arm/Group Title	STA-9090
Arm/Group Description	This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer. 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.
Period Title: Overall Study
STARTED	22
COMPLETED	22
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	STA-9090
Arm/Group Description	This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer. 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.
Overall Participants	22
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	19 86.4%
>=65 years	3 13.6%
Sex: Female, Male (Count of Participants)
Female	22 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Overall Response Rate
Description	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
Time Frame	Radiological imaging studies to evaluate tumor status will be repeated during the rest week (Days 22 to 28) of every third cycle

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	STA-9090
Arm/Group Description	This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer. 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.
Measure Participants	20
Number [participants]	20 90.9%

Adverse Events

Arm/Group Title	STA-9090
Arm/Group Description	This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer. 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.
All Cause Mortality
	STA-9090
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	STA-9090
	Affected / at Risk (%)	# Events
Total	6/22 (27.3%)
Cardiac disorders
Cardiac General, other	1/22 (4.5%)	1
Gastrointestinal disorders
Pain - Abdomen NOS	1/22 (4.5%)	1
General disorders
Death not assoc w CTCAE term- Death NOS	1/22 (4.5%)	1
Death not assoc w CTCAE term-Disease prog NOS	1/22 (4.5%)	1
Hepatobiliary disorders
Liver dysfunction/failure	1/22 (4.5%)	1
Metabolism and nutrition disorders
Sodium, low (hyponatremia)	1/22 (4.5%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)	2/22 (9.1%)	3
Pleural effusion (non-malig)	1/22 (4.5%)	2
Other (Not Including Serious) Adverse Events
	STA-9090
	Affected / at Risk (%)	# Events
Total	20/22 (90.9%)
Blood and lymphatic system disorders
Leukocytes (total WBC)	1/22 (4.5%)	1
Gastrointestinal disorders
Diarrhea	4/22 (18.2%)	6
Dry mouth/salivary gland (xerostomia)	1/22 (4.5%)	1
General disorders
Fatigue (asthenia, lethargy, malaise)	2/22 (9.1%)	2
Investigations
ALT, SGPT	2/22 (9.1%)	5
AST, SGOT	4/22 (18.2%)	9
Alkaline phosphatase	4/22 (18.2%)	8
Amylase	2/22 (9.1%)	7
Bilirubin (hyperbilirubinemia)	3/22 (13.6%)	4
CPK (creatine phosphokinase)	1/22 (4.5%)	3
Creatinine	1/22 (4.5%)	1
Hemoglobin	4/22 (18.2%)	15
INR	2/22 (9.1%)	6
Lipase	2/22 (9.1%)	4
Lymphopenia	4/22 (18.2%)	5
Neutrophils/granulocytes (ANC/AGC)	1/22 (4.5%)	1
Platelets	1/22 (4.5%)	2
Weight loss	1/22 (4.5%)	1
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)	4/22 (18.2%)	7
Glucose, low (hypoglycemia)	2/22 (9.1%)	3
Magnesium, low (hypomagnesemia)	1/22 (4.5%)	1
Phosphate, low (hypophosphatemia)	1/22 (4.5%)	2
Potassium, high (hyperkalemia)	1/22 (4.5%)	1
Sodium, low (hyponatremia)	1/22 (4.5%)	1
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb	1/22 (4.5%)	1
Psychiatric disorders
Insomnia	2/22 (9.1%)	2
Vascular disorders
Hypertension	1/22 (4.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.