NCT02096341

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

1.8 years

First QC Date

March 20, 2014

Last Update Submit

January 19, 2016

Conditions

Malignant Solid TumorLymphomas

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Serious and Non-Serious Adverse Events

    10 weeks

Secondary Outcomes (2)

  • 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

Study Arms (1)

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

RRx-001DRUG

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

RRx-001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant or breast-feeding.
  • Use of anti-coagulant therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Related Links

MeSH Terms

Conditions

Lymphoma

Interventions

RRx-001

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jeffrey Infante, MD

    SCRI Development Innovations, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2014

First Posted

March 26, 2014

Study Start

April 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations

US(1)