Spots Global Cancer Trial Database for A Phase 1 Pilot Study of the Subcutaneous (s.c.) Route to Facilitate the Administration of RRx-001

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Trial Identification

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

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

Study ID: NCT02096341

Conditions

Malignant Solid Tumor

Lymphomas

Interventions

RRx-001

Study Description

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.