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

NCT ID: NCT02801097

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-30
• Study Completion Date: 2019-12-09

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

RRx-001

Intervention Type: DRUG

Irinotecan

Intervention Type: DRUG

Interventions

RRx-001

Intervention Type: DRUG

Irinotecan

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed diagnosis of an advanced, malignant, solid tumor(s) with all standard treatment options having been exhausted or declined.
• Eastern Cooperative Group (ECOG) performance status is 0-2 at Screening.
• Measurable disease per RECIST v1.1 by radiographic techniques
• Acceptable liver function, serum creatinine and hematological status
• Female subjects of childbearing potential, and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception beginning on Study Day 1 and continuing until at least four weeks after administration of the subject's final dose of RRx-001.
• Subjects with brain metastases are eligible

Exclusion Criteria

• Concurrent anticancer therapy; however, radiotherapy is allowed
• Any history of hypersensitivity to irinotecan
• Cholangitis that required treatment or intervention within 4 weeks of study enrollment
• Bilirubin > 2.0 mg/dL
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study
• If female, subject is pregnant and/or breastfeeding.
• UGT1A1*28 homozygote or heterozygote
• BMI >35

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EpicentRx, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bryan Oronsky, MD

Role: STUDY_DIRECTOR

EpicentRx, Inc.

Locations

University of California, Davis

Sacramento, California, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

RRx001-16-01

Identifier Type: -

Identifier Source: org_study_id