Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 13 for:    Recruiting Studies | Interventional Studies | glioma | United States | Start date from 10/09/2020 to 01/05/2021

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04541225
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Nuvation Bio Inc.

Brief Summary:
NUV-422-02 is a first-in-human, open-label, Phase 1/2 dose escalation and multiple expansion cohort study designed to evaluate the safety and efficacy of NUV-422. The study population is comprised of adults with recurrent or refractory high-grade gliomas. All patients will self-administer NUV-422 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.

Condition or disease Intervention/treatment Phase
Glioma Glioma, Malignant Glioma, Mixed Glial Cell Tumors Drug: NUV-422 Phase 1 Phase 2

Layout table for study information
Study Type : Interventional
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
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
Actual Study Start Date : December 8, 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 1 Dose Escalation
NUV-422 administered at escalating dose levels until the maximum tolerated dose (MTD) is reached.
Drug: NUV-422
NUV-422

Experimental: Phase 2 Dose Expansion
NUV-422 administered at the recommended Phase 2 dose (RP2D).
Drug: NUV-422
NUV-422




Primary Outcome Measures :
  1. Phase 1 Dose Escalation [ Time Frame: During the dose-limiting toxicity (DLT) period (28 days) ]
    Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs).

  2. Phase 2 Dose Expansion: Cohort 1 [ Time Frame: Every 8 weeks through study treatment, an average of 6 months ]
    Objective response rate (ORR)

  3. Phase 2 Dose Expansion: Cohort 2 [ Time Frame: Intraoperatively after 21 days of study treatment ]
    Evaluation of NUV-422 concentration in plasma, including peak plasma concentration (Cmax).

  4. Phase 2 Dose Expansion: Cohort 2 [ Time Frame: Intraoperatively after 21 days of study treatment ]
    Evaluation of NUV-422 half-life in plasma.

  5. Phase 2 Dose Expansion: Cohort 2 [ Time Frame: Intraoperatively after 21 days of study treatment ]
    Evaluation of NUV-422 concentration in brain tumor tissue.

  6. Phase 2 Dose Expansion: Cohort 2 [ Time Frame: Intraoperatively after 21 days of study treatment ]
    Evaluation of NUV-422 effects on brain tumor cell proliferation ratio pre and post-treatment.



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Histologically confirmed diagnosis of high grade glioma
  2. Evidence of recurrence after treatment (ie, surgery, radiation, or temozolomide) or refractory (or intolerant) to treatment
  3. Recovered from toxicity to prior anti-cancer therapy
  4. Adequate bone marrow and organ function
  5. 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:

Phase 1 Dose Escalation Cohorts

  1. Measurable or non-measurable disease
  2. Karnofsky Performance Status (KPS) score ≥ 60

Phase 2 Expansion Cohort 1

  1. Available tumor tissue
  2. Received prior therapy with radiation or radiation plus temozolomide
  3. Radiographic evidence of progression and measurable disease as determined by the Investigator per standard criteria
  4. KPS score ≥ 70

Phase 2 Expansion Cohort 2

  1. Received prior therapy with radiation or radiation plus temozolomide
  2. Radiographic evidence of progression and measurable disease as determined by the Investigator per standard criteria
  3. KPS score ≥ 70
  4. Eligible for surgical resection

Key Exclusion Criteria:

  1. Have received chemotherapy, radiation, or biological anti-cancer therapy within 14 days prior to the first dose of IP
  2. Has a history of or current use of bevacizumab as therapy for brain cancer
  3. 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 enrollment
  4. 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
  5. 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
  6. Females who are pregnant or breast feeding

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Clinical Trials at Nuvation Bio 332-208-6102 ClinicalTrials@nuvationbio.com

Locations
Layout table for location information
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Patrick Y Wen, MD    617-632-2166      
Contact: Rachel Fox    617-632-6668      
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Thomas Kaley, MD    212-639-5122      
Contact: Christine Jarjies    646-907-2567      
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jordi Rodon, MD, PhD    713-563-1930      
United States, Utah
University of Utah Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Howard Colman, MD    801-585-0255    Howard.Colman@hci.utah.edu   
Contact: Sara Woltz    801-585-0431    Sara.Woltz@hci.utah.edu   
Sponsors and Collaborators
Nuvation Bio Inc.
Layout table for additonal information
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: February 10, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nuvation Bio Inc.:
Phase 1
Phase 2
malignant glioma
Additional relevant MeSH terms:
Layout table for MeSH terms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue