Lymphomas Clinical Trial
Official title:
A Phase 1 Pilot Study of the Subcutaneous (s.c.) Route to Facilitate the Administration of RRx-001
To investigate the dosage of RRx-001 by the subcutaneous route.
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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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