SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)
NCT05303519 · Glioma, Astrocytoma, Grade IV, IDH1-mutant Glioma
RecruitingThis 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. The purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled. The purpose of Part 3 will be to evaluate the efficacy of safusidenib in participants with residual or recurrent IDH1-mutant Grade 3 oligodendroglioma who have received surgery as their only treatment. Part 3 will be an open-label single-arm cohort and will enroll participants concurrently with Part 2.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 44 more
SponsorNuvation Bio Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations
NCT04094610 · Locally Advanced Solid Tumors, Metastatic Solid Tumors,
Lymphoma RecruitingPhase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D). Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ROS1 or NTRK1-3 alterations.
PhasePhase 1 / Phase 2
TypeInterventional
Age25 Years
WhereLos Angeles, California, United States + 67 more
SponsorTurning Point Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults
NCT04323046 ·
Glioblastoma, Malignant Glioma,
Recurrent Glioblastoma RecruitingThis phase I trial studies the side effects of nivolumab before and after surgery in treating children and young adults with high grade glioma that has come back (recurrent) or is increasing in scope or severity (progressive). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
PhasePhase 1
TypeInterventional
Age6 Months – 25 Years
WhereBirmingham, Alabama, United States + 19 more
SponsorSabine Mueller, MD, PhD
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies
NCT04678648 · Advanced Malignant Solid Neoplasm, RAS Mutation,
Lung Cancer RecruitingRSC-101 is a Phase 1a/1b clinical trial of RSC-1255 in adult study participants with advanced solid tumor malignancies who are intolerant of existing therapies known to provide clinical benefit, have disease that has progressed after standard therapy, or have previously failed other therapies. The study has two phases. The purpose of Phase 1a (Dose Escalation) is to confirm the appropriate treatment dose and Phase 1b (Dose Expansion) is to characterize the safety and efficacy of RSC-1255.
PhasePhase 1
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 2 more
SponsorRasCal Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
NCT03970447 ·
Glioblastoma RecruitingGlioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. All institutions are enrolling Newly Diagnosed participants. Institutions also enrolling Recurrent participants are marked with an asterisk (\*).
PhasePhase 2 / Phase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 62 more
SponsorGlobal Coalition for Adaptive Research
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing the Addition of an Anti-Cancer Drug, AZD1390, During Radiation Therapy for Newly Diagnosed High Grade Glioma, Diffuse Midline Glioma, or Diffuse Intrinsic Pontine Glioma
NCT06894979 · Childhood Astrocytoma, Childhood Diffuse Intrinsic Pontine Glioma, Childhood Diffuse Midline Glioma
RecruitingThis phase I clinical trial studies the side effects and best dose of AZD1390 and to see how well it works when given together with radiation therapy for the treatment of pediatric patients with high grade glioma, diffuse midline glioma or diffuse intrinsic pontine glioma. AZD1390 is in a class of medications called kinase inhibitors. It works by blocking the signals that cause cancer cells to repair deoxyribonucleic acid damage caused by cancer treatments, such as radiation therapy. This may help overcome resistance to therapy seen in these cancers and therefore lead to increased death of cancer cells. Radiation therapy uses high energy x-rays or particles to kill cancer cells and shrink tumors. Giving AZD1390 with radiation may be safe, tolerable, and effective in treating pediatric patients with high grade glioma, diffuse midline glioma or diffuse intrinsic pontine glioma.
PhasePhase 1
TypeInterventional
Age12 Months – 22 Years
WhereBirmingham, Alabama, United States + 19 more
SponsorChildren's Oncology Group
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
RecruitingThis phase I/II trial tests the safety, side effects and best dose of selinexor given in combination with the usual chemotherapy (temozolomide) and compares the effect of this combination therapy versus the usual chemotherapy alone (temozolomide) in treating patients with glioblastoma that has come back (recurrent). Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE). It works by blocking a protein called CRM1, which may keep cancer cells from growing and may kill them. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. Giving selinexor in combination with usual chemotherapy (temozolomide) may shrink or stabilize the tumor better than the usual chemotherapy with temozolomide alone in patients with recurrent glioblastoma.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 35 more
SponsorNational Cancer Institute (NCI)
▾Tap for detailsClick for full details — eligibility, all locations, contacts Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss
RecruitingThis is a first in human study of TNG456 alone and in combination with abemaciclib in patients with advanced or metastatic solid tumors known to have an MTAP loss. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific solid tumor types with a confirmed MTAP loss. The study drug, TNG456, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 191 participants.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 14 more
SponsorTango Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Biologic Association Between Metabolic Magnetic Resonance-positron Emission Tomograph (MR-PET) and Tissue Measures of Glycolysis in Brain Tumors of Infiltrating Glioblastoma Cells
NCT06059690 ·
Glioblastoma Multiforme, Glycolytic Index, Epidermal Growth Factor Receptor
RecruitingThe purpose of this project is to validate a new combined MRI and PET imaging technique as a biomarker or measure of glycolysis in brain tumors. To accomplish this, the investigators propose obtaining image-guided measures of tissue pH and biopsied tissue in tumor areas selected for bulk resection surgery. Investigators will then correlate the imaging measurements with pH, RNA expression, protein expression, and bioenergetics measurements of key glycolytic enzymes.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States
SponsorJonsson Comprehensive Cancer Center
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