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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02801097
Recruitment Status : Active, not recruiting
First Posted : June 15, 2016
Last Update Posted : July 23, 2020
Information provided by (Responsible Party):
EpicentRx, Inc.

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.

Condition or disease Intervention/treatment Phase
Malignant Solid Tumor Metastatic Cancer Advanced Cancer Drug: RRx-001 Drug: Irinotecan Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 30, 2016
Actual Primary Completion Date : November 22, 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: RRx-001
Drug: Irinotecan

Primary Outcome Measures :
  1. Number, frequency and type of adverse events [ Time Frame: 14 Weeks ]

Secondary Outcome Measures :
  1. Duration of clinical benefit rate [ Time Frame: 1 year ]
    Duration of clinical benefit (Stable disease or better) using Response Evaluation Criteria in Solid Tumors [RECIST v1.1] criteria

  2. Progression-Free Survival [ Time Frame: 1 year ]
    Progression-Free Survival (PFS) using Response Evaluation Criteria in Solid Tumors

  3. Overall Response rate [ Time Frame: 1 year ]
    Proportion of patients with reduction in tumor burden using Response Evaluation Criteria in Solid Tumors

  4. Overall Survival [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02801097

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United States, California
University of California, Davis
Sacramento, California, United States, 95817
United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
EpicentRx, Inc.
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Study Director: Bryan Oronsky, MD EpicentRx, Inc.
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Responsible Party: EpicentRx, Inc. Identifier: NCT02801097    
Other Study ID Numbers: RRx001-16-01
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents