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RRx-001 Given With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and Central Nervous System Tumors

NCT04525014 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2024-10-31

No results posted yet for this study

Summary

The PIRATE study tests the experimental drug RRx-001 in combination with 2 chemotherapy drugs that are commonly used in patients with cancer. RRx-001 has been used alone and with other anti-cancer medicines in adults. However, the investigators do not know what effects it will have in children and young adults.

Conditions

  • Brain Tumor, Recurrent
  • Brain Tumor, Pediatric
  • Central Nervous System Neoplasms
  • Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

DRUG

RRx-001

RRx-001 will be administered every 3 weeks via intravenous infusion at three dose levels: 0.5 mg/m2 (Max 1 mg), 1 mg/m2 (Max 2 mg), and 2 mg/m2 (Max 4 mg).

DRUG

Temozolomide

100 mg/m2 (children ≥0.5 m2) or 3 mg/kg (children \<0.5 m2) daily for 5 days beginning on day 1 of each cycle

DRUG

Irinotecan

90 mg/m2 taken orally daily for 5 days administered 1 hour after temozolomide

Sponsors & Collaborators

  • Texas Children's Cancer Center

    collaborator OTHER

  • EpicentRx, Inc.

    lead INDUSTRY

Principal Investigators

  • Bryan Oronsky, MD · EpicentRx, Inc.

  • Stephanie Fetzko, MD · Texas Children's Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-26
Primary Completion
2024-07-29
Completion
2024-07-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04525014 on ClinicalTrials.gov