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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02096341
Other study ID # RRx001-12-01
Secondary ID
Status Terminated
Phase Phase 1
First received March 20, 2014
Last updated January 19, 2016
Start date April 2014
Est. completion date January 2016

Study information

Verified date January 2016
Source EpicentRx, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Sarah Cannon Research Institute Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
EpicentRx, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Serious and Non-Serious Adverse Events 10 weeks Yes
Secondary Area under the plasma concentration versus time curve (AUC) of RRx-001-glutathione conjugate 1 day No
Secondary Peak Plasma Concentration (Cmax) of RRx-001-glutathione conjugate 1 day No
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