Ignite Creation Date:
2024-05-06 @ 8:42 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02801097
Status:
TERMINATED
Last Update Posted:
2022-05-17
First Post:
2016-06-10
Brief Title:
RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer PAYLOAD
Sponsor:
EpicentRx Inc
Organization:
EpicentRx Inc
Study Overview
Official Title:
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
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sufficient patients enrolled to end study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAYLOAD
Brief 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
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 v11 definition of progression is not met
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None