A Phase 1 Pilot Study of the Subcutaneous (s.c.) Route to Facilitate the Administration of RRx-001
NCT ID: NCT02096341
Last Updated: 2016-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
2 participants
INTERVENTIONAL
2014-04-30
2016-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
RRx-001
RRx-001 Dose level 1 (16 mg/m2) twice weekly
RRx-001 Dose level 2 (27 mg/m2) twice weekly
Interventions
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RRx-001
RRx-001 Dose level 1 (16 mg/m2) twice weekly
RRx-001 Dose level 2 (27 mg/m2) twice weekly
Eligibility Criteria
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Inclusion Criteria
* 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
* Use of anti-coagulant therapy.
18 Years
ALL
No
Sponsors
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EpicentRx, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffrey Infante, MD
Role: PRINCIPAL_INVESTIGATOR
SCRI Development Innovations, LLC
Locations
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Sarah Cannon Research Institute
Nashville, Tennessee, United States
Countries
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Related Links
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EpicentRx, Inc Home page.
Other Identifiers
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RRx001-12-01
Identifier Type: -
Identifier Source: org_study_id
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