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Safety and Pharmacokinetic Study of RRx-001 in Cancer Subjects

NCT01359982 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-11-01

Study results available
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Summary

The purpose of this study is to evaluate the safety and pharmacokinetic profile of RRx-001 for injection in subjects with advanced solid tumors or lymphomas for which there are no currently accepted curative therapies. This study will also conduct an exploratory evaluation of objective tumor response using CT or MRI.

Conditions

Interventions

DRUG

RRx-001

Dose level 1 (10 mg/m2)

DRUG

RRx-001

Dose Level 2 (16.7 mg/m2)

DRUG

RRx-001

Dose Level 3 (24.6 mg/m2)

DRUG

RRx-001

Dose Level 4 (33 mg/m2)

DRUG

RRx-001

Dose Level 5 (55.0 mg/m2)

DRUG

RRx-001

Dose Level 6 (83 mg/m2)

Sponsors & Collaborators

  • EpicentRx, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeffrey Infante, MD · SCRI Development Innovations, LLC

  • Tony Reid, MD · University of California, San Diego

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-02-28
Completion
2015-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01359982 on ClinicalTrials.gov