NCT04541225

Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Nuvation Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioma
• Glioma, Malignant
• Glioma, Mixed
• Glial Cell Tumors
• Breast Cancer
• Breast Carcinoma
• Cancer of Breast
• Cancer of the Breast
• Breast Tumor
• Malignant Tumor of Breast
• Advanced Breast Cancer
• Advanced Breast Carcinoma
• Metastatic Breast Cancer
• Metastatic Breast Carcinoma
• Prostate Cancer
• Prostatic Cancer
• Cancer of Prostate
• Cancer of the Prostate
• Prostate Neoplasm
• Castrate Resistant Prostate Cancer
• Castration-resistant Prostate Cancer
• Castration Resistant Prostatic Neoplasms
• Glioblastoma
• Recurrent Glioblastoma

Interventions

Type	Name	Description
DRUG	NUV-422	NUV-422 is an investigational drug for oral dosing.

Timeline

• Start date: 2020-12-08
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2020-09-09
• Last updated: 2023-07-14

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study