A Phase I Study of STA-5312 in Subjects With Advanced or Metastatic Solid Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 solid tumors.

• To determine the pharmacokinetics of STA-5312.

Secondary Objective:

• To assess antitumor activity of STA-5312 administration.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Synta Pharmaceuticals Corp.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.