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

Sponsor
EpicentRx, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT02096341
Collaborator
(none)
2
Enrollment
1
Location
1
Arm
21
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Pilot Study of the Subcutaneous (s.c.) Route to Facilitate the Administration of RRx-001
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: RRx-001

RRx-001 will be 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.

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

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with Serious and Non-Serious Adverse Events [10 weeks]

Secondary Outcome Measures

  1. Area under the plasma concentration versus time curve (AUC) of RRx-001-glutathione conjugate [1 day]

  2. Peak Plasma Concentration (Cmax) of RRx-001-glutathione conjugate [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sarah Cannon Research Institute Nashville Tennessee United States 37203

Sponsors and Collaborators

  • EpicentRx, Inc.

Investigators

  • Principal Investigator: Jeffrey Infante, MD, SCRI Development Innovations, LLC

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
EpicentRx, Inc.
ClinicalTrials.gov Identifier:
NCT02096341
Other Study ID Numbers:
  • RRx001-12-01
First Posted:
Mar 26, 2014
Last Update Posted:
Jan 21, 2016
Last Verified:
Jan 1, 2016

Study Results

No Results Posted as of Jan 21, 2016