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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.

Tracking Information
First Submitted Date  ICMJE June 10, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date July 23, 2020
Actual Study Start Date  ICMJE August 30, 2016
Actual Primary Completion Date November 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2016)
Number, frequency and type of adverse events [ Time Frame: 14 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2016)
  • 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
  • Progression-Free Survival [ Time Frame: 1 year ]
    Progression-Free Survival (PFS) using Response Evaluation Criteria in Solid Tumors
  • Overall Response rate [ Time Frame: 1 year ]
    Proportion of patients with reduction in tumor burden using Response Evaluation Criteria in Solid Tumors
  • Overall Survival [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer (PAYLOAD)
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Malignant Solid Tumor
  • Metastatic Cancer
  • Advanced Cancer
Intervention  ICMJE
  • Drug: RRx-001
  • Drug: Irinotecan
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 4, 2019)
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2016)
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date November 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02801097
Other Study ID Numbers  ICMJE RRx001-16-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party EpicentRx, Inc.
Study Sponsor  ICMJE EpicentRx, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bryan Oronsky, MD EpicentRx, Inc.
PRS Account EpicentRx, Inc.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP