Advanced Solid Tumors Clinical Trial
Official title:
A Phase I Study of NK012 in Combination With Infusional 5-fluorouracil and Leucovorin in Patients With Advanced Solid Tumors Followed by a Dose Expansion Phase in Patients With Metastatic Colorectal Cancer
The primary objective is to determine the maximum tolerated dose/recommended phase II dose of the combination regimen of NK012 and 5-fluorouracil in patients with advanced solid tumors.
On Day 1 of each 28 day cycle, NK012 will be administered as a 30 minute IV infusion,
followed by continuous infusion of 5-FU over 46 hours. On Day 15 of each cycle, patients
again receive 5-FU continuous infusion. Treatment is expected to continue for 6 cycles,
unless disease progression or the development of unacceptable toxicity requires
discontinuation of the drug. At the discretion of the investigator, patients who show signs
of benefit may continue beyond 6 cycles.
Once a MTD/RD has been determined for the combination regimen, a dose expansion cohort of
patients with metastatic colorectal cancer will be treated at the determined MTD.
(Prior to Amendment 2, patients were receiving NK012 and 5-FU and leucovorin (LV). The
dosing regimen was changed as of Amendment 2 to NK012 and 5-FU.)
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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|---|---|---|---|
| Active, not recruiting |
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