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

• Status: Active, not recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EpicentRx, Inc.
• Treatments: Camptothecin; Irinotecan

Criteria

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