NCT02801097

RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer (PAYLOAD)

A Phase I, Open-Label, Multiple Ascending Dose Study to Assess the Safety and Tolerability of RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer Patients Without Life-Prolonging Therapies of Demonstrated Clinical Benefit (PAYLOAD)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: EpicentRx, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Malignant Solid Tumor
• Metastatic Cancer
• Advanced Cancer

Interventions

Type	Name	Description
DRUG	RRx-001
DRUG	Irinotecan

Timeline

• Start date: 2016-08-30
• Primary completion: 2018-11-22
• Completion: 2019-12-09
• First posted: 2016-06-15
• Last updated: 2022-05-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study