The purpose of this study is to evaluate the safety and pharmacokinetic profile of RRx-001 for injection in subjects with advanced solid tumors or lymphomas for which there are no currently accepted curative therapies. This study will also conduct an exploratory evaluation of objective tumor response using CT or MRI.
The DINAMIC (DINitroazetidines As Medications In Cancer) trial represents a provascular approach to temporarily change tumor blood flow and oxygenation. Blood supply to most tumors is poor, causing parts of tumors to have a low oxygen content which promotes aggressiveness and metastasis. The DINAMIC trial uses specific imaging techniques (including ultrasound), biopsy, and breath analysis to provide an early assessment of therapeutic activity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Moores University of California San Diego Cancer Center
La Jolla, California, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Number of Patients Who Had an Adverse Events
The total number of patients who experienced at least one adverse event while receiving treatment.
Time frame: From time of receiving a dose of RRx-001 through 92 days
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Dose Level 4 (33 mg/m2)
Dose Level 5 (55.0 mg/m2)
Dose Level 6 (83 mg/m2)