Study Stopped
Sponsor decision
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
1 other identifier
interventional
74
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2020
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2020
CompletedFirst Posted
Study publicly available on registry
September 9, 2020
CompletedStudy Start
First participant enrolled
December 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedJuly 14, 2023
July 1, 2023
1.7 years
August 21, 2020
July 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Phase 1 Dose Escalation: Safety and tolerability of NUV-422 to determine the recommended Phase 2 dose (RP2D)
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
During the DLT period (28 days)
Study Arms (1)
Phase 1 Dose Escalation
EXPERIMENTALNUV-422 will be administered at escalating dose levels until the maximum tolerated dose (MTD) is reached.
Interventions
Eligibility Criteria
You may qualify if:
- For All Cohorts:
- Recovered from toxicity to prior anti-cancer therapy
- Adequate bone marrow and organ function
- Appropriate candidate for NUV-422 monotherapy
- Life expectancy of \> 3 months
- High-Grade Glioma:
- Histologically confirmed diagnosis of high-grade glioma
- Evidence of recurrence after treatment (ie, surgery, radiation, or temozolomide) or refractory (or intolerant) to treatment
- Measurable or non-measurable disease
- Karnofsky Performance Status (KPS) score ≥ 60
- HR+HER2- Metastatic Breast Cancer:
- Men and women who are not suitable for surgical resection or radiotherapy for the purpose of cure
- Diagnosis of locally advanced or HR+HER2- metastatic breast cancer
- Evidence of progression as determined by the Investigator per standard criteria
- Patients must have endocrine-resistant disease
- +9 more criteria
You may not qualify if:
- Have received chemotherapy, hormonal therapy (with the exception of ongoing LHRH analogs in male patients and premenopausal women), radiation, or biological anti-cancer therapy within 14 days prior to the first dose of NUV-422
- Has a history of or current use of bevacizumab (glioma and brain metastases only)
- Received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent or 21 days (or \< 5 half-lives) for myelosuppressive agent prior to the first dose of NUV-422
- Requires systemic corticosteroid therapy \> 4 mg/day (\> 2 mg/day for Expansion Cohort 2) of dexamethasone or equivalent or increasing doses of systemic corticosteroids during the 7 days prior to enrollment
- Requires anti-seizure medications that are known to be strong inducers of CYP3A4/5 enzymes (carbamazepine, phenytoin) or has a recent history of uncontrolled or intermittent seizures
- Females who are pregnant or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Arizona Oncology Associates
Tucson, Arizona, 85711, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Carolina BioOncology Institute
Huntersville, North Carolina, 28078, United States
Prisma Health Cancer Institute
Greenville, South Carolina, 29605, United States
Texas Oncology P.A. Austin
Austin, Texas, 78705, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Oncology
Tyler, Texas, 75702, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2020
First Posted
September 9, 2020
Study Start
December 8, 2020
Primary Completion
August 31, 2022
Study Completion
August 31, 2022
Last Updated
July 14, 2023
Record last verified: 2023-07