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

Lymphomas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02096341
• Other study ID #: RRx001-12-01
• 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

• Lymphomas
• Malignant Solid Tumor
• Neoplasms

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

External Links

•   EpicentRx, Inc Home page.