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

Sponsor
EpicentRx, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT02801097
Collaborator
(none)
28
Enrollment
2
Locations
1
Arm
39.3
Actual Duration (Months)
14
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
28 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 :
Aug 30, 2016
Actual Primary Completion Date :
Nov 22, 2018
Actual Study Completion Date :
Dec 9, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number, frequency and type of adverse events [14 Weeks]

Secondary Outcome Measures

  1. Duration of clinical benefit rate [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 [1 year]

    Progression-Free Survival (PFS) using Response Evaluation Criteria in Solid Tumors

  3. Overall Response rate [1 year]

    Proportion of patients with reduction in tumor burden using Response Evaluation Criteria in Solid Tumors

  4. Overall Survival [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, Davis Sacramento California United States 95817
2 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903

Sponsors and Collaborators

  • EpicentRx, Inc.

Investigators

  • Study Director: Bryan Oronsky, MD, EpicentRx, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
EpicentRx, Inc.
ClinicalTrials.gov Identifier:
NCT02801097
Other Study ID Numbers:
  • RRx001-16-01
First Posted:
Jun 15, 2016
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms
Irinotecan

Study Results

No Results Posted as of May 17, 2022