BridgeMD
New treatment option for Glioma
Official title SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)
ClinicalTrials.gov ID: NCT05303519
What this study is testing
What is safusidenib?
safusidenib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for glioma.
Also referred to as DS-1001b, AB-218.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent/progressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key for Part 1:
- Patient must be ≥ 18 years of age at the time of signing the informed consent form (ICF).
- Patient must have histologically confirmed recurrent or progressive WHO Grade 2 glioma or Grade 3 glioma with IDH1 R132H or R132C mutation confirmed...
- The IDH mutation, and other applicable gene/molecular alterations (see Table 10-2) are determined by a validated assay as performed in Clinical...
- Patient has received no more than 2 prior therapies for disease recurrence/progression.
You likely can't join if
- for Part 1:
- Prior anti-cancer therapy, within the applicable periods shown below, before the start of the protocol treatment:
- 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
See the full eligibility criteria
- Key for Part 1:
- Patient must be ≥ 18 years of age at the time of signing the informed consent form (ICF).
- 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.
- 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...
- Patient has received no more than 2 prior therapies for disease recurrence/progression.
- Patient has disease recurrence or progression or cannot tolerate the most recent therapy.
- 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...
- Must be ≥18 years old at the time of signing the ICF.
- 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.
- Has adequate hematologic and organ function Key for Part 2:
- Diagnosis of histologically confirmed IDH1-mutant Grade 2, Grade 3 with high risk features or Grade 4 astrocytoma, per WHO 2021 classification and Investigator Assessment.
- 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...
- Must not have experienced tumor recurrence or progression between first day of radiotherapy and randomization by local assessment per RANO 2.0.
- Participants must have completed radiation therapy with a minimum of 80% of planned treatment completed (with or without concurrent temozolomide) and between 6 and 12 cycles of adjuvant . Randomization must occur at...
- Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection), with the most recent surgery having occurred at least 90 days and no longer than 5 years before the date of...
- Have histologically confirmed Grade 3 IDH-mutant oligodendroglioma according to WHO 2021 criteria per local assessment.
- Have residual or recurrent measurable disease per RANO 2.0 and confirmed by BICR, at the time of enrollment.
- Have an IDH1 mutation (R132H/C/G/S/L). The presence of 1p19q co-deletion must also be confirmed. All results must be generated using a validated assay performed in a CLIA-certified/CAP-accredited (or local equivalent)...
- for Part 1:
- Prior anti-cancer therapy, within the applicable periods shown below, before the start of the protocol treatment:
- 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. Key Exclusion Criteria for Part 2 and 3:
- 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.
- Have brainstem or spinal cord involvement either as primary location, site of multifocal involvement, or by significant tumor extension.
- Significant functional or neurocognitive deficits, including uncontrolled seizures, that would preclude participation in protocol-defined study activities, as assessed by Investigator.
- Evidence of diffuse leptomeningeal disease.
- History of significant cardiac disease within 12 months prior to randomization (if applicable) or first dose of study drug (if randomization does not apply).
- If taking corticosteroids, must be on a stable or decreasing dose for the 14 days prior to randomization (if applicable) or first dose of study drug (if randomization does not apply).
- Participants with other malignancies must have received curative treatment and been disease-free for at least 3 years. Curatively resected skin cancer or curatively treated carcinoma in situ is allowed.
- Have a condition that would interfere with, or increase the risk of, study participation. Key Exclusion Criteria for Part 2 1. Participants may not have received any anticancer treatments other than surgery, radiation...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Palo Alto, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Kansas City, Kansas, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
+ 28 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; La Jolla, California, United States; Los Angeles, California, United States; Newport Beach, California, United States; Palo Alto, California, United States and 42 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.