Spots Global Cancer Trial Database for Safety and Pharmacokinetic Study of RRx-001 in Cancer Subjects

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Trial Identification

Brief Title: Safety and Pharmacokinetic Study of RRx-001 in Cancer Subjects

Official Title: 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

Study ID: NCT01359982

Conditions

Malignant Solid Tumor

Lymphomas

Interventions

RRx-001

Study Description

Brief 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.