NCT02909777

Trial of CUDC-907 in Children and Young Adults With Relapsed or Refractory Solid Tumors, CNS Tumors, or Lymphoma

Phase 1 Trial of CUDC-907 in Children and Young Adults With Relapsed or Refractory Solid Tumors, CNS Tumors, or Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating a novel drug called CUDC-907 as a possible treatment for resistant (refractory) pediatric solid tumors (including neuroblastoma), lymphoma, or brain tumors.

Detailed description

This is a Phase I clinical trial. A Phase I clinical trial tests the safety of an investigational intervention and also tries to find the best dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved CUDC-907 as a treatment option for any disease. This is the first time that CUDC-907 will be given to children. In this research study, the investigators are evaluating a new drug, CUDC-907, as a potential new treatment for children with solid tumors, lymphomas and brain tumors. CUDC-907 is an oral drug that blocks certain proteins in tumor cells. These proteins may be important in the growth of some cancers. Laboratory experiments and results from adult studies demonstrate that CUDC-907 may stop tumor growth and, in some cases, cause tumor cells to die. CUDC-907 has been tested in adults with cancer to find out about side effects and dosing in adults. The primary goal of this study is to evaluate side effects of CUDC-907 and find the best dose of CUDC-907 when used in children. Other goals of this study are to determine whether this drug may have benefits against the types of cancer seen in children and to measure the effects of CUDC-907 in the blood.

Conditions

• Lymphoma
• Neuroblastoma
• Brain Tumor
• Solid Tumor

Interventions

Type	Name	Description
DRUG	CUDC-907

Timeline

• Start date: 2016-10-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2016-09-21
• Last updated: 2026-02-11

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study