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The primary objective of this study is to determine how much XMT-1001 can safely be taken by patients with advanced solid cancerous tumors (the Maximum Tolerated Dose).
The study will also determine:
- The recommended dose of XMT-1001 for the next human study
- The safety and tolerability of XMT-1001
- The pharmacokinetics (PK) of XMT-1001 (how XMT-1001 behaves in the body)
- Evidence of XMT-1001 anti-tumor activity
This is an open-label, ascending-dose cohort (group) study of XMT-1001 administered intravenously over 30 minutes every 21 days (1 Cycle). Blood sampling for PK analyses will be performed immediately prior to dosing, and 9 times after dosing. Patients will be assessed for toxicities known to occur with other drugs of this class, such as bone marrow suppression, elevated liver function enzymes, hemorrhagic cystitis, and diarrhea. Tumor imaging will be performed every 2 cycles.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Advanced Cancer (Solid Tumors)
TGen Clinical Research Services at Scottsdale Healthcare
Published on BioPortfolio: 2014-08-27T03:39:19-0400
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