A Phase 1 Pilot Study of the Subcutaneous (s.c.) Route to Facilitate the Administration of RRx-001

Phase 1

Terminated

• Conditions: Malignant Solid Tumor; Lymphomas
• Interventions: Drug: RRx-001

• Registration Number: NCT02096341
• Lead Sponsor: EpicentRx, Inc.

Brief Summary

To investigate the dosage of RRx-001 by the subcutaneous route.

Detailed Description

This is a phase I, open-label, dose-escalation study of RRx-001. Subjects will receive RRx-001 administered as subcutaneous injections twice weekly for at least 8 weeks. At least three subjects must complete 2 weeks of treatment with RRx-001 at each dose level, before escalation to the next higher RRx-001 dose level; 2 doses-16 and 27 mg/m2- will be tested.

The purpose of the study is to extend the dosage options for RRx-001 since faster subcutaneous (SC) administration may increase convenience versus the traditional IV method. The study also will also measure the mean concentrations of an RRx-001 metabolite in the blood (pharmacokinetics; PK) versus the IV formulation.

Study Timeline

• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-26
• Study Start: 2014-04
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• At least 18 years old.
• ECOG (performance) status of 0, 1 or 2.
• Histologically or cytologically confirmed primary or metastatic advanced solid tumors or lymphoma. Subjects with curative treatment options are not eligible for the protocol.
• No active ongoing cancer treatment (except for prostate cancer subjects receiving luteinizing hormone-releasing hormone (LHRH) agonists and anti-androgens such as; Flutamide, Dutasteride, and Finasteride).
• Adequate organ and bone marrow function.
• Male and female subjects of childbearing potential must agree to use contraception.

Exclusion Criteria

• Pregnant or breast-feeding.
• Use of anti-coagulant therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RRx-001	RRx-001	RRx-001 will be administered as subcutaneous injections twice weekly for at least 8 weeks. At least three subjects must complete 2 weeks of treatment with RRx-001 at each dose level, before escalation to the next higher RRx-001 dose level; 2 doses-16 and 27 mg/m2- will be tested.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Serious and Non-Serious Adverse Events	10 weeks

Secondary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax) of RRx-001-glutathione conjugate	1 day
Area under the plasma concentration versus time curve (AUC) of RRx-001-glutathione conjugate	1 day

Trial Locations

Locations (1)

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States