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A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets
Multiple Cancer Types
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma
cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of
ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change
in disease activity will be assessed.
ABBV-453 is an investigational drug being developed for the treatment of R/R MM. This study
will include a dose escalation phase to determine the best dose of ABBV-453. Approximately 21
adult participants with R/R MM will be enrolled in the study in approximately 12 sites
worldwide.
Participants will receive oral ABBV-453 tablets once daily (QD) in 28-day cycles.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at an approved
institution (hospital or clinic). The effect of the treatment will be frequently checked by
medical assessments, blood tests, and side effects.
cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of
ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change
in disease activity will be assessed.
ABBV-453 is an investigational drug being developed for the treatment of R/R MM. This study
will include a dose escalation phase to determine the best dose of ABBV-453. Approximately 21
adult participants with R/R MM will be enrolled in the study in approximately 12 sites
worldwide.
Participants will receive oral ABBV-453 tablets once daily (QD) in 28-day cycles.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at an approved
institution (hospital or clinic). The effect of the treatment will be frequently checked by
medical assessments, blood tests, and side effects.
Multiple Myeloma,
Phase I
I
Baljevic, Muhamed
NCT05308654
VICCHEMP2230
Study of BMF-219, a Covalent Menin Inhibitor, in Adult Patients With AML, ALL With KMT2A/ MLL1r, NPM1 and Other Mutations
Multiple Cancer Types
A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral
covalent menin inhibitor, in adult patients with acute myeloid leukemia, acute lymphocytic
leukemia with KMT2A/ MLL1r, NPM1 and other mutations.
covalent menin inhibitor, in adult patients with acute myeloid leukemia, acute lymphocytic
leukemia with KMT2A/ MLL1r, NPM1 and other mutations.
Leukemia,
Phase I
I
Kishtagari, Ashwin
NCT05153330
VICCHEMP2195
Ruxolitinib Phosphate before and after Stem Cell Transplant in Treating Patients with Primary or Secondary Myelofibrosis
Hematologic
Hematologic
This phase II trial studies how well ruxolitinib phosphate before and after stem cell transplant works in treating patients with primary or secondary myelofibrosis. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patients immune cells and help destroy any remaining cancer cells.
Hematologic
II
Oluwole, Olalekan
NCT03427866
VICCCTT1863
Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B)
Substudy 03B is part of a larger research study that is testing experimental treatments for
renal cell carcinoma (RCC). The larger study is the umbrella study (U03).
The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations
of investigational agents in participants with advanced second line plus (2L+) clear cell
renal cell carcinoma (ccRCC).
This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety
lead-in phase will be used to demonstrate a tolerable safety profile for the combination of
investigational agents. There will be no hypothesis testing in this study.
renal cell carcinoma (RCC). The larger study is the umbrella study (U03).
The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations
of investigational agents in participants with advanced second line plus (2L+) clear cell
renal cell carcinoma (ccRCC).
This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety
lead-in phase will be used to demonstrate a tolerable safety profile for the combination of
investigational agents. There will be no hypothesis testing in this study.
Not Available
I/II
Beckermann, Kathryn
NCT04626518
VICCUROP2070
To Evaluate Maximally Tolerated Dose (MTD), Safety and Efficacy of CPI-613 (Devimistat) Plus Hydroxychloroquine in Patients With Relapsed or Refractory Clear Cell Sarcoma of Soft Tissue
Sarcoma
Sarcoma
The goal of this trial in Phase I is to determine the maximally tolerated dose (MTD) of
hydroxychloroquine in combination with devimistat in patients with relapsed or refractory
Clear Cell Sarcomas of the Soft Tissue and to describe the full toxicity profile. In Phase
II, the goal is to evaluate the response rate [Complete Rate (CR) + Partial Rate (PR)] of the
combination of devimistat and hydroxychloroquine in patients with relapse or refractory Clear
Cell Sarcoma of the Soft Tissue and to evaluate the PK and PK/PD profiles for efficacy and
safety of the combination of devimistat and hydroxychloroquine.
hydroxychloroquine in combination with devimistat in patients with relapsed or refractory
Clear Cell Sarcomas of the Soft Tissue and to describe the full toxicity profile. In Phase
II, the goal is to evaluate the response rate [Complete Rate (CR) + Partial Rate (PR)] of the
combination of devimistat and hydroxychloroquine in patients with relapse or refractory Clear
Cell Sarcoma of the Soft Tissue and to evaluate the PK and PK/PD profiles for efficacy and
safety of the combination of devimistat and hydroxychloroquine.
Sarcoma
I/II
Davis, Elizabeth
NCT04593758
VICCSARP2147
EA2176: Phase 3 Clinical Trial of Carboplatin and Paclitaxel +/- Nivolumab in Metastatic Anal Cancer Patients
Rectal
Rectal
This phase 3 trial compares the addition of nivolumab to chemotherapy (carboplatin and paclitaxel) versus usual treatment (chemotherapy alone) for the treatment of anal cancer that has spread to other places in the body (metastatic). 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. Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab together with carboplatin and paclitaxel may help doctors find out if the treatment is better or the same as the usual approach.
Rectal
III
Eng, Cathy
NCT04444921
ECOGGIEA2176
Dabrafenib Combined with Trametinib after Radiation Therapy in Treating Patients with Newly-Diagnosed High-Grade Glioma
Multiple Cancer Types
This phase II trial studies how well the combination of dabrafenib and trametinib works after radiation therapy in children and young adults with high grade glioma who have a genetic change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill tumor cells and reduce the size of tumors. Dabrafenib and trametinib may stop the growth of tumor cells by blocking BRAF and MEK, respectively, which are enzymes that tumor cells need for their growth. Giving dabrafenib with trametinib after radiation therapy may work better than treatments used in the past in patients with newly-diagnosed BRAF V600-mutant high-grade glioma.
Neuro-Oncology,
Pediatrics
II
Pastakia, Devang
NCT03919071
COGACNS1723
A Study to See if Memantine Protects the Brain during Radiation Therapy Treatment for a Brain Tumor
Multiple Cancer Types
This phase III trial compares memantine to usual treatment in treating patients with brain tumors that are newly diagnosed or has come back (recurrent). Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (attention, memory, or other thought processes) in children and adolescents receiving brain radiation therapy to treat a primary brain tumor.
Neuro-Oncology,
Pediatrics
III
Esbenshade, Adam
NCT04939597
COGACCL2031
Samotolisib in Treating Patients with Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders with TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial)
Multiple Cancer Types
This phase II Pediatric MATCH trial studies how well samotolisib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with TSC or PI3K/MTOR mutations that have spread to other places in the body (metastatic) and have come back (recurrent) or do not respond to treatment (refractory). Samotolisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Germ Cell (Pediatrics),
Miscellaneous,
Neuroblastoma (Pediatrics),
Pediatric Lymphoma,
Pediatric Solid Tumors,
Pediatrics,
Wilms / Other Kidney (Pediatrics)
II
Borinstein, Scott
NCT03213678
COGAPEC1621D
A Study of the Drugs Selumetinib versus Carboplatin/Vincristine in Patients with Neurofibromatosis and Low-Grade Glioma
Multiple Cancer Types
This phase III trial studies if selumetinib works just as well as the standard treatment with carboplatin/vincristine (CV) for subjects with NF1-associated low grade glioma (LGG), and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway (vision nerves). Selumetinib is a drug that works by blocking some enzymes that low-grade glioma tumor cells need for their growth. This results in killing tumor cells. Drugs used as chemotherapy, such as carboplatin and vincristine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether selumetinib works better in treating patients with NF1-associated low-grade glioma compared to standard therapy with carboplatin and vincristine.
Neuro-Oncology,
Pediatrics
III
Pastakia, Devang
NCT03871257
COGACNS1831
