This is a phase 1 open-label trial to evaluate the safety, pharmacodynamics and clinical activity of RRx-001 administered in combination with irinotecan. RRx-001 is associated with resensitization to irinotecan in tumors that are previously refractory. This effect has been attributed to the ability of RRx-001 to restore the expression of aberrantly silenced genes, thus re-establishing pathway functions. However, resensitization may have more than one mechanism, among them Pgp pump inhibition and vascular modulation, leading to improved penetration of standard chemotherapy.
This dose escalation study consists of 5 sequential dose cohorts each administered RRx-001 with irinotecan. After the first 3 subjects of each cohort complete Cycle 1, the safety will be assessed before moving to the next dose level. Subjects in the current cohort will continue treatment immediately following the completion of Cycle 1, for as long as therapy is tolerated and the RECIST v.1.1 definition of progression is not met.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
University of California, Davis
Sacramento, California, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Number, frequency and type of adverse events
Time frame: 14 Weeks
Duration of clinical benefit rate
Duration of clinical benefit (Stable disease or better) using Response Evaluation Criteria in Solid Tumors \[RECIST v1.1\] criteria
Time frame: 1 year
Progression-Free Survival
Progression-Free Survival (PFS) using Response Evaluation Criteria in Solid Tumors
Time frame: 1 year
Overall Response rate
Proportion of patients with reduction in tumor burden using Response Evaluation Criteria in Solid Tumors
Time frame: 1 year
Overall Survival
Time frame: 2 years
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