Title: A phase 1 trial of RRx-001 in combination with irinotecan and temozolomide for pediatric patients with recurrent or progressive malignant solid and central nervous system tumors
Principal Investigators: Holly Lindsay, MD, and Patricia Baxter, MD, both of Texas Children’s Cancer Center in Houston
Description: Researchers are conducting a phase 1 trial to assess the safety and efficacy of RRx-001 in combination with irinotecan and temozolomide in children and young adults with recurrent or progressive malignant solid and central nervous system tumors.
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Patients will receive RRx-001 every 3 weeks via intravenous infusion, in combination with oral irinotecan and temozolomide.
The primary outcome measure is the recommended phase 2 dose of RRx-001. Key secondary endpoints include adverse events, progression-free survival, and overall survival.
To be eligible for this study, patients must be 1 to 21 years of age. They must have recurrent or progressive malignant primary brain tumors, spinal cord tumors, or solid tumors. For a complete list of eligibility criteria, please see the reference.
Status: Recruiting
This study is sponsored by EpicentRx, Inc., in collaboration with Texas Children’s Cancer Center.
Reference:
ClinicalTrials.gov. RRx-001 given with irinotecan and temozolomide for pediatric patients with recurrent or progressive malignant solid and central nervous system tumors (PIRATE). NCT04525014. Accessed June 16, 2022.
