NCT01359982

Safety and Pharmacokinetic Study of RRx-001 in Cancer Subjects

A Phase I, Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of RRx-001 in Subjects With Advanced Solid Tumors or Lymphomas For Which There Are No Currently Accepted Curative Therapies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: EpicentRx, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The DINAMIC (DINitroazetidines As Medications In Cancer) trial represents a provascular approach to temporarily change tumor blood flow and oxygenation. Blood supply to most tumors is poor, causing parts of tumors to have a low oxygen content which promotes aggressiveness and metastasis. The DINAMIC trial uses specific imaging techniques (including ultrasound), biopsy, and breath analysis to provide an early assessment of therapeutic activity.

Conditions

• Malignant Solid Tumor
• Lymphomas

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2011-05-25
• Last updated: 2024-11-01
• Results posted: 2024-11-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study