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

NCT02801097 | Terminated Phase 1 FDA Drug

• 1 other identifier: RRx001-16-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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.

Conditions

Malignant Solid Tumor; Metastatic Cancer; Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• Number, frequency and type of adverse events

  14 Weeks

Secondary Outcomes (4)

• Duration of clinical benefit rate

  1 year

• Progression-Free Survival

  1 year

• Overall Response rate

  1 year

• Overall Survival

  2 years

Study Arms (1)

RRx-001 + Irinotecan

EXPERIMENTAL

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.

Drug: RRx-001; Drug: Irinotecan

Interventions

RRx-001 DRUG

RRx-001 + Irinotecan

Irinotecan DRUG

RRx-001 + Irinotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EpicentRx, Inc.: lead

Study Sites (2)

University of California, Davis

Sacramento, California, 95817, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

RRx-001; Irinotecan

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Bryan Oronsky, MD

  EpicentRx, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 15, 2016
• Study Start: August 30, 2016
• Primary Completion: November 22, 2018
• Study Completion: December 9, 2019
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)