Status:
COMPLETED
A Phase I Study of STA-5312 in Subjects With Advanced or Metastatic Solid Tumors
Lead Sponsor:
Synta Pharmaceuticals Corp.
Conditions:
Advanced or Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Primary Objectives: * To determine the safety, toxicity and the maximum tolerated dose (MTD) of intravenous STA-5312 when administered weekly (3 of 4 weeks) to subjects with advanced or metastatic so...
Detailed Description
This is a Phase I open-label, dose-escalation safety study in subjects with refractory non hematologic malignancies. STA-5312 will be administered intravenously. Administration is anticipated to take ...
Eligibility Criteria
Inclusion
- Male and female subjects aged at least 18 years with histologically-confirmed non hematological malignancy that is metastatic or unresectable and for which no standard therapy exists.
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2.
- Peripheral neuropathy less than Grade 2 on National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3 adverse event scale.
- Subjects must have acceptable organ and marrow function during the Screening Period as defined below. (Note: Subjects must meet these criteria at each pre-dose visit to receive additional doses of STA-5312).
- Absolute neutrophil count (ANC) greater than 1500 cells/µL
- Platelets greater than 100,000/µL
- Total bilirubin must be \<1.5 times ULN
- Aspartate transaminase (AST) ≤3 times ULN or less than 5 times the ULN in subjects with liver metastases
- Alanine transaminase (ALT) ≤3 times ULN or less than 5 times the ULN in subjects with liver metastases
- Adequate renal function (serum creatinine \<2.0 mg/dL).
- Electrocardiogram (ECG) without evidence of clinically significant ventricular arrhythmias or active ischemia as determined by the investigator.
- Documented cardiac ejection fraction greater than 50% obtained within 30 days of administration of the first dose.
- The effects of STA-5312 on the developing human fetus are unknown. Therefore, women of childbearing potential (defined as women over 50 years of age or history of amenorrhea for \<12 months prior to study entry) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a female subject become pregnant or suspect she is pregnant while participating in this study, she should inform the treating physician immediately.
- Ability to understand and willingness to sign a written informed consent document.
Exclusion
- Women who are pregnant or breast-feeding.
- Subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
- Subjects with previous high-dose chemotherapy with autologous allogeneic hematopoietic stem cell transplantation.
- Subjects with primary brain tumors or active brain metastases are excluded. Subjects with previously treated brain metastases who are not receiving corticosteroids or anticonvulsants are eligible.
- History of stroke within 6 months of treatment or other significant neurological limitations.
- Use of any investigational agents within 4 weeks of study enrollment.
- History of severe allergic reactions to excipients (e.g. Tween 80/polysorbate 80), including severe hypersensitivity reactions defined as greater than Grade 3 based on NCI CTC version 3.
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00276913
Start Date
June 1 2004
Last Update
February 3 2014
Active Locations (1)
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1
Steven Limentani, MD
Charlotte, North Carolina, United States, 28203