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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02096341

Enrollment

Registered

2014-03-26

Start date

2014-04-30

Completion date

2016-01-31

Last updated

2016-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Solid Tumor, Lymphomas

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.

Interventions

DRUGRRx-001

RRx-001 Dose level 1 (16 mg/m2) twice weekly RRx-001 Dose level 2 (27 mg/m2) twice weekly

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Number of Participants with Serious and Non-Serious Adverse Events	10 weeks

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026