A Phase 1 Pilot Study of the Subcutaneous (s.c.) Route to... | NCT02096341

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

NCT02096341

Sponsor

EpicentRx, Inc.

Status

Terminated

Last Update Posted

Jan 21, 2016Estimated

Enrollment

2Actual

Phase

Phase 1

Conditions

Malignant Solid Tumor
Lymphomas

Interventions

RRx-001

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Subcutaneous administration of RRx-001 is no longer of interest.

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Mar 20, 2014

First Submission Date that Met QC Criteria

Mar 21, 2014

First Posted Date

Mar 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2016

Last Update Posted Date

Jan 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RRx-001	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RRx-001	Drug	RRx-001 Dose level 1 (16 mg/m2) twice weekly RRx-001 Dose level 2 (27 mg/m2) twice weekly	RRx-001

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Serious and Non-Serious Adverse Events		10 weeks

Secondary Outcomes

Measure	Description	Time Frame
Area under the plasma concentration versus time curve (AUC) of RRx-001-glutathione conjugate		1 day
Peak Plasma Concentration (Cmax) of RRx-001-glutathione conjugate		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey Infante, MD	SCRI Development Innovations, LLC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sarah Cannon Research Institute		Nashville	Tennessee	37203	United States

Label	URL
EpicentRx, Inc Home page.	View source

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C577469	RRx-001

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided