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Brief Title: Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors
Official Title: Phase 1/2 Dose Escalation, Safety, Pharmacokinetics, and Efficacy Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors
Study ID: NCT04541225
Brief Summary: At the time of study termination, NUV-422-02 was a first-in-human, open-label, Phase 1 dose escalation study designed to evaluate the safety and efficacy of NUV-422. The study population comprised adults with recurrent or refractory high-grade gliomas (HGGs), metastatic breast cancer (mBC), with and without brain metastases, and recurrent or refractory metastatic castration-resistant prostate cancer (mCRPC). All patients self-administered NUV-422 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Arizona Oncology Associates, Tucson, Arizona, United States
Miami Cancer Institute, Miami, Florida, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Carolina BioOncology Institute, Huntersville, North Carolina, United States
Prisma Health Cancer Institute, Greenville, South Carolina, United States
Texas Oncology P.A. Austin, Austin, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Texas Oncology, Tyler, Texas, United States
University of Utah Huntsman Cancer Institute, Salt Lake City, Utah, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States