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

Part of paid clinical trials in Sacramento, California.

Sponsor
EpicentRx, Inc.
Study ID
NCT02801097
Phase
PHASE1
Status
Terminated

Conditions

  • Advanced Cancer
  • Malignant Solid Tumor
  • Metastatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 30, 2016
Status verified
May 2022
Primary completion
Nov 22, 2018
Completion
Dec 9, 2019

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RRx-001 + Irinotecan
    Cohorts of participants with an advanced, malignant, solid tumor(s) will receive weekly doses of RRx-001 for 3 weeks, switching at week 4 to every-other-week treatments of RRx-001 with irinotecan.

Primary Outcome Measure

Number, frequency and type of adverse events [ Time Frame: 14 Weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, DavisSacramentoCalifornia95817-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-

Find similar trials in Sacramento, CA

By research site
University of California, Davis· Sacramento, CARutgers Cancer Institute of New Jersey· New Brunswick, NJ

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