NCT02215512

Brief Summary

In this dose-escalation study, the safety and tolerability of escalating dose levels of RRx-001 administered intravenously twice a week in subjects with brain metastases receiving whole brain radiation therapy (WBRT) will be assessed. Once a maximum tolerated dose is identified, further (up to approximately 30) participants will be recruited. The study will use MRI to monitor changes in tumor blood flow associated with RRx-001.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2015

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

February 6, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2016

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2020

Completed
Last Updated

November 3, 2021

Status Verified

November 1, 2021

Enrollment Period

1.8 years

First QC Date

August 11, 2014

Last Update Submit

November 1, 2021

Conditions

Brain Metastases

Outcome Measures

Primary Outcomes (1)

  • Number, frequency and type of adverse events

    To identify the maximum tolerated dose (MTD) of RRx-001 in combination with WBRT, defined as the dose of RRx-001 associated with a 20% probability of dose-limiting toxicity (DLT) in subjects with brain metastases

    42 days

Secondary Outcomes (5)

  • Objective Response Rate

    4 months

  • Clinical Benefit Rate

    4 months

  • Intracranial Progression Free Survival

    4 months

  • Overall Survival

    10 months

  • Brain Imaging Parameters

    6 weeks

Study Arms (1)

RRx-001 + WBRT

EXPERIMENTAL

RRx-001 administered intravenously twice a week (10, 17, 33, 55 mg) in subjects with brain metastases receiving whole brain radiation therapy (WBRT).

Drug: RRx-001 + WBRT

Interventions

RRx-001 + WBRTDRUG

Subjects will receive a combination of RRx-001 and whole brain radiotherapy.

Also known as: Whole brain radiotherapy and RRx-001
RRx-001 + WBRT

Eligibility Criteria

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

You may qualify if:

  • Written informed consent
  • Age ≥18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • One or more brain metastases
  • Prior radiation therapy to the brain is allowed with the exception of whole brain irradiation
  • Subjects must be neurologically stable for at least 14 days prior to first dose of study drug;
  • Male and female subjects who are not surgically sterile or post-menopausal must agree to use reliable methods of birth control for the duration of the study and for 90 days after the last dose of study drug administration; male partners of female subjects should use condoms for the duration of the study, and for 90 days after the last dose of study drug administration

You may not qualify if:

  • Pregnant or lactating females
  • Any evidence of severe or uncontrolled diseases
  • Inadequate bone marrow reserve
  • Previous whole brain radiotherapy
  • Prior RRx-001 therapy
  • Insufficient recovery from all side effects of previous anticancer therapies
  • Evidence of blood clotting or bleeding abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Providence Saint John's Health Center

Santa Monica, California, 90404, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Allegiance Health

Jackson, Michigan, 49201, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

The Cancer Institute of New Jersey (Rutgers University)

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

RRx-001

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Michelle Kim, MD

    University of Michigan

    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

August 11, 2014

First Posted

August 13, 2014

Study Start

February 6, 2015

Primary Completion

November 28, 2016

Study Completion

November 12, 2020

Last Updated

November 3, 2021

Record last verified: 2021-11

Locations

US(5)