Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors
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ClinicalTrials.gov Identifier: NCT04541225 |
Recruitment Status :
Terminated
(Sponsor decision)
First Posted : September 9, 2020
Last Update Posted : July 14, 2023
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Condition or disease | Intervention/treatment | Phase |
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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 | Drug: NUV-422 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 74 participants |
Allocation: | N/A |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | December 8, 2020 |
Actual Primary Completion Date : | August 31, 2022 |
Actual Study Completion Date : | August 31, 2022 |
Arm | Intervention/treatment |
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Experimental: Phase 1 Dose Escalation
NUV-422 will be administered at escalating dose levels until the maximum tolerated dose (MTD) is reached.
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Drug: NUV-422
NUV-422 is an investigational drug for oral dosing. |
- Phase 1 Dose Escalation: Safety and tolerability of NUV-422 to determine the recommended Phase 2 dose (RP2D) [ Time Frame: During the DLT period (28 days) ]Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria
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
Cohort-Specific Inclusion Criteria: In addition to the inclusion criteria listed above, the following criteria apply based on enrollment into specific cohorts.
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
- Prior therapy: At least 1 but not more than 4 prior lines of systemic therapies for locally advanced inoperable or metastatic BC including at least 1 prior line of hormonal therapy in combination with an approved CDK4/6 inhibitor
- Have no known active or symptomatic central nervous system (CNS) disease
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
Metastatic Castration-Resistant Prostate Cancer:
- Diagnosis of metastatic castration-resistant prostate cancer with disease progression despite castrate levels of testosterone
- Evidence of disease progression as determined by Investigator per standard criteria
- Have no known active or symptomatic CNS disease
- Received prior therapy with anti-androgen(s) and taxane-based chemotherapy for castration-resistant disease
- ECOG PS ≤ 2
Key Exclusion Criteria for All Cohorts:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04541225
United States, Arizona | |
Arizona Oncology Associates | |
Tucson, Arizona, United States, 85711 | |
United States, Florida | |
Miami Cancer Institute | |
Miami, Florida, United States, 33176 | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 | |
United States, North Carolina | |
Carolina BioOncology Institute | |
Huntersville, North Carolina, United States, 28078 | |
United States, South Carolina | |
Prisma Health Cancer Institute | |
Greenville, South Carolina, United States, 29605 | |
United States, Texas | |
Texas Oncology P.A. Austin | |
Austin, Texas, United States, 78705 | |
Texas Oncology-Baylor Charles A. Sammons Cancer Center | |
Dallas, Texas, United States, 75246 | |
The University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Texas Oncology | |
Tyler, Texas, United States, 75702 | |
United States, Utah | |
University of Utah Huntsman Cancer Institute | |
Salt Lake City, Utah, United States, 84112 | |
United States, Virginia | |
Virginia Cancer Specialists | |
Fairfax, Virginia, United States, 22031 |
Responsible Party: | Nuvation Bio Inc. |
ClinicalTrials.gov Identifier: | NCT04541225 |
Other Study ID Numbers: |
NUV-422-02 |
First Posted: | September 9, 2020 Key Record Dates |
Last Update Posted: | July 14, 2023 |
Last Verified: | July 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Phase 1 malignant glioma metastatic breast cancer metastatic castration-resistant prostate cancer |
Carcinoma Neoplasms Breast Neoplasms Prostatic Neoplasms Glioblastoma Glioma Prostatic Neoplasms, Castration-Resistant Recurrence Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms by Site Breast Diseases Skin Diseases Disease Attributes |
Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases Astrocytoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue |