Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
125 participants
INTERVENTIONAL
2023-06-05
2028-03-01
Brief Summary
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The purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 3 astrocytoma with high-risk features or Grade 4 IDH1-mutant astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double blind, and placebo controlled.
Detailed Description
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Part 2 will include approximately 100 participants with IDH1-mutant astrocytoma, Grade 3 with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Participants will be randomized (1:1) after their last dose of adjuvant temozolomide to receive either oral safusidenib 250 mg BID or placebo in 28-day continuous cycles. Patients will continue treatment until progression of disease or until other discontinuation criteria are met. The tumor response evaluation will be conducted on a regular basis until progression of disease per Blinded Independent Central Review (BICR), consent withdrawal, or death, whichever occurs first. Long-term survival follow-up will be conducted as well.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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safusidenib 125mg bid (part 1)
safusidenib 125mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.
safusidenib
safusidenib administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with agent safusidenib until disease progression or development of other unacceptable toxicity.
safusidenib 250mg bid (part 1)
safusidenib 250mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.
safusidenib
safusidenib administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with agent safusidenib until disease progression or development of other unacceptable toxicity.
safusidenib 500mg qd (part 1)
safusidenib 500mg qd administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.
safusidenib
safusidenib administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with agent safusidenib until disease progression or development of other unacceptable toxicity.
safusidenib 375mg bid (part 1)
safusidenib 375mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.
safusidenib
safusidenib administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with agent safusidenib until disease progression or development of other unacceptable toxicity.
safusidenib 500mg bid (part 1)
safusidenib 500mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.
safusidenib
safusidenib administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with agent safusidenib until disease progression or development of other unacceptable toxicity.
safusidenib 250mg bid (Part 2)
safusidenib administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment until disease progression or another reason for discontinuation occurs.
safusidenib
safusidenib administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with agent safusidenib until disease progression or development of other unacceptable toxicity.
placebo (Part 2)
Placebo administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with placebo until disease progression or another reason for discontinuation occurs.
Placebo
Placebo administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with placebo until disease progression or another reason for discontinuation occurs.
Interventions
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safusidenib
safusidenib administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with agent safusidenib until disease progression or development of other unacceptable toxicity.
Placebo
Placebo administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with placebo until disease progression or another reason for discontinuation occurs.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient must have histologically confirmed recurrent or progressive WHO Grade 2 glioma or Grade 3 glioma with IDH1 R132H or R132C mutation confirmed by immunohistochemistry or molecular genetic testing.
4\. The IDH mutation, and other applicable gene/molecular alterations (see Table 10-2) are determined by a validated assay as performed in Clinical Laboratory Improvement Amendments (CLIA)-certified/College of American Pathologists (CAP)-accredited or locally equivalent clinical laboratories. Prior clinical pathology report fulfilling the diagnosis criteria prior to screening with tumor samples collected is acceptable for patient enrollment in both Part 1 and Part 2.
5\. Patient has received no more than 2 prior therapies for disease recurrence/progression.
6\. Patient has disease recurrence or progression or cannot tolerate the most recent therapy.
7\. Patient must have a measurable lesion(s) as per the RANO-HGG criteria for primarily enhancing lesions or RANO-LGG criteria for primarily non-enhancing lesions. The lesion (s) must be visible on 2 or more axial slices and have perpendicular diameters of at least 10 × 10 mm. The definition of primarily enhancing lesions or primarily non-enhancing lesions is referred to Section 8.3.1.
1. Must be ≥18 years old at the time of signing the ICF.
2. Diagnosis of histologically confirmed IDH1-mutant Grade 3 with high risk features or Grade 4 astrocytoma, per WHO 2021 classification and Investigator Assessment.
3. Have an IDH1 mutation (R132H/C/G/S/L) based on IHC (R132H only), polymerase chain reaction (PCR), or next-generation sequencing (NGS). CDKN2A/B status and at least 1 of the following must be confirmed: absence of 1p19q co-deletion by fluorescence in situ hybridization, array comparative genomic hybridization, or NGS; presence of an ATRX loss of function mutation by NGS; or loss of normal ATRX expression by IHC. A validated assay performed in a CLIA-certified/CAP-accredited (or local equivalent) clinical laboratory must be used for all of the aforementioned results. Documentation of biomarker status, including redacted molecular pathology and NGS reports, must be provided during Screening.
4. Must not have experienced disease recurrence or disease progression.
5. Participants must have completed radiation therapy with a minimum of 90% of planned treatment completed (with or without concurrent temozolomide) and between 6 and 12 cycles of adjuvant temozolomide and have no evidence of disease progression. Randomization must occur at least 28 days and not more than 75 days after the final dose of temozolomide.
6. Must agree to submit sufficient tumor tissue for retrospective biomarker and histological analyses. This requirement may be waived in rare circumstances with approval by the Sponsor.
7. Has adequate hematologic and organ functions
Exclusion Criteria
* Systemic drug therapies: within 3 weeks (lomustine within 6 weeks)
* Surgery: within 3 weeks
* Radiation therapy: within 12 weeks
* Investigational agents: within 5 half-lives for other investigational agents
* Patient did receive the prior therapy targeted to IDH1 mutation..
* Known hypersensitivity to safusidenib or to any drug with similar chemical structure or to any other excipient present in the pharmaceutical form of safusidenib.
1. Participants may not have received any anticancer treatments other than surgery, radiation, concurrent/adjuvant temozolomide, and tumor-treating fields. Tumor-treating fields must be discontinued prior to randomization.
2. Participants with prior or anticipated treatment with anti-angiogenic agents such as Avastin (bevacizumab), agents known to target IDH1 or IDH2, or investigational agents for glioma are excluded.
3. Have brainstem or spinal cord involvement either as primary location, site of multifocal involvement, or by significant tumor extension.
4. Significant functional or neurocognitive deficits, including uncontrolled seizures, that would preclude participation in protocol-defined study activities, as assessed by Investigator.
5. Evidence of diffuse leptomeningeal disease by MRI.
6. History of significant cardiac disease within 12 months prior to randomization.
7. If taking corticosteroids, must be on a stable or decreasing dose for the 14 days prior to randomization.
8. Participants with other malignancies must have received curative treatment and been disease-free for at least 3 years. Curatively resected non-melanoma skin cancer or curatively treated carcinoma in situ is allowed.
9. Have a condition that would interfere with, or increase the risk of, study participation.
18 Years
ALL
No
Sponsors
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AnHeart Therapeutics Inc.
INDUSTRY
Nuvation Bio Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama
Birmingham, Alabama, United States
Mayo Clinic - Arizona
Phoenix, Arizona, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
University of California, Los Angeles
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Stanford University
Palo Alto, California, United States
University of California
San Francisco, California, United States
University of Colorado Health Cancer Care
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
University of Florida Health
Gainesville, Florida, United States
Mayo Clinic - Florida
Jacksonville, Florida, United States
University of Miami Health
Miami, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, United States
New York University Langone Health
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Insititute, University of Utah
Salt Lake City, Utah, United States
UVA Health, Emily Couric Clinical Cancer Cente
Charlottesville, Virginia, United States
Fred Hutch Cancer Center
Seattle, Washington, United States
University of Wisconsin Health
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Shirley Gibbs
Role: primary
Brittany Mason
Role: primary
Ciara Lugo
Role: primary
Soheila Abbassi
Role: primary
Role: backup
Jason Ledesma
Role: primary
Sahara Rout
Role: primary
Karishma Kumar-Wessel
Role: primary
Stephanie Biller
Role: primary
Amy Rodrigues
Role: primary
Alicia Wyrick
Role: primary
Mayo Clinic Mailbox
Role: primary
Irene Marino
Role: primary
Kelvisha Norton
Role: primary
Xuam Lam
Role: primary
Julie Miller
Role: primary
Amanda Dresser
Role: primary
Phillip Alther
Role: primary
Sonia Velazquez
Role: primary
Leslie Nehring
Role: primary
Kassie DiOrio
Role: primary
Olga Garduno-Ortega
Role: primary
Research Nurse Navigator
Role: primary
Nancy Keith
Role: primary
Madeleine Ruff
Role: backup
Jessicka Hamilton
Role: primary
Marci Ciolfi
Role: primary
Omar Raslan
Role: primary
Eva Gachimova
Role: primary
Rachel Kingsford
Role: primary
CJ Woodburn, 434-243-9900
Role: primary
Madhuri Poduri
Role: primary
Erin Clements
Role: primary
Other Identifiers
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AB-218-G203
Identifier Type: -
Identifier Source: org_study_id