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

EpicentRx

Status and phase: Terminated; Phase 1

Conditions: Lymphomas; Malignant Solid Tumor

Treatments: Drug: RRx-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT02096341

RRx001-12-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

RRx-001

Experimental group

Description:

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.

Treatment:

Drug: RRx-001