The purpose of this study is to determine whether MBP-426 (liposomal oxaliplatin suspension for injection) is safe and effective in the treatment of advanced or metastatic solid tumors.
Study Phase 1 Study Type (Interventional/Observational) Interventional Study Design Purpose: Treatment Allocation: Nonrandomized trial Masking: Open Control: Dose Comparison Assignment: Single Group Endpoint: Safety/Efficacy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Dose escalation starting at 6 mg/m2, IV (in the vein) on Day 1 of each 21-day cycle. Number of Cycles: Up to 6 cycles, until unacceptable toxicity, disease progression, or intercurrent illness requires treatment discontinuation. Patients may continue treatment beyond 6 cycles if the Investigator determines that additional treatment would provide further benefit for the patient as long as toxicity remains acceptable.
M.D. Anderson Cancer Center
Houston, Texas, United States
Institute for Drug Development
San Antonio, Texas, United States
Incidence of dose-limiting toxicity, determination of maximum tolerated dose (MTD), and recommended Phase 2 dose
Time frame: Within 21 days of treatment administration
Tumor shrinkage according to RECIST
Time frame: Measured every 6 weeks (i.e., every 2 cycles) while receiving study drug
Limited exploratory assays
Time frame: Variable throughout study
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