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

NCT00276913 | Completed Phase 1

• 1 other identifier: 5312-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 solid tumors.
• To determine the pharmacokinetics of STA-5312. Secondary Objective:
• To assess antitumor activity of STA-5312 administration.

Conditions

Advanced or Metastatic Solid Tumors

Interventions

STA-5312 DRUG

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Synta Pharmaceuticals Corp.: lead

Study Sites (1)

Steven Limentani, MD

Charlotte, North Carolina, 28203, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2006
• First Posted: January 13, 2006
• Study Start: June 1, 2004
• Last Updated: February 3, 2014

Record last verified: 2014-01

Locations

US (1)