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



Status:Terminated
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2014
End Date:January 2016

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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.

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.
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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