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

Metastatic Cancer Clinical Trial

— PAYLOAD  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02801097
• Other study ID #: RRx001-16-01
• Status: Terminated
• Phase: Phase 1
• Start date: August 30, 2016
• Est. completion date: December 9, 2019

Study information

• Verified date: May 2022
• Source: EpicentRx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: December 9, 2019
• Est. primary completion date: November 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Malignant Solid Tumor
• Metastatic Cancer
• Neoplasms

Intervention

Drug:
• RRx-001

• Irinotecan

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	University of California, Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
EpicentRx, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number, frequency and type of adverse events		14 Weeks
Secondary	Duration of clinical benefit rate	Duration of clinical benefit (Stable disease or better) using Response Evaluation Criteria in Solid Tumors [RECIST v1.1] criteria	1 year
Secondary	Progression-Free Survival	Progression-Free Survival (PFS) using Response Evaluation Criteria in Solid Tumors	1 year
Secondary	Overall Response rate	Proportion of patients with reduction in tumor burden using Response Evaluation Criteria in Solid Tumors	1 year
Secondary	Overall Survival		2 years