Royal North Shore Hospital | Renal Medicine - Renal Research Unit
Status and phase
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About
The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of SQ3370 in patients with advanced solid tumors.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Phase 1: Inclusion Criteria:
Phase 1: Exclusion Criteria:
Prior exposure to 300 mg/m^2 of Dox HCl or DOXIL / CAELYX ® or 600 mg/m^2 of Epirubicin HCl
Congestive heart failure (CHF), severe myocardial insufficiency, or cardiac arrhythmia
Any of the following within 28 days prior to Cycle 1 Day 1:
Trastuzumab or trastuzumab emtansine dosed within 7 months prior to Cycle 1 Day 1.
Any transfusion within 14 days prior to Cycle 1 Day 1.
Pregnant or breast-feeding women.
Known active CNS metastases and/or carcinomatous meningitis or symptomatic brain metastasis. Participants with previously treated brain metastases may participate provided they are radiologically stable
History of allergic reactions attributed to Dox or other anthracyclines, NaHA, hyaluronic acid, or gram-positive bacterial proteins
History or evidence of clinically unstable/uncontrolled disorder, condition, or disease
Phase 2a Expansion Group 1 (Extremity STS): Inclusion
Phase 2a Expansion Group 1 (Extremity STS): Exclusion
Phase 2a Expansion Group 2 (Unresectable STS): Inclusion
Phase 2a Expansion Group 2 (Unresectable STS): Exclusion
Phase 2a Expansion Group 3a (Head and Neck): Inclusion
Phase 2a Expansion Group 3a (Head and Neck): Exclusion
Primary purpose
Allocation
Interventional model
Masking
145 participants in 6 patient groups
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Central trial contact
Shasqi Clinical Operations
Data sourced from clinicaltrials.gov
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