Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors
NCT04541225 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74
Last updated 2023-07-14
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
- DRUG
-
NUV-422
NUV-422 is an investigational drug for oral dosing.
Sponsors & Collaborators
-
Nuvation Bio Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-08
- Primary Completion
- 2022-08-31
- Completion
- 2022-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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