Clinical Trials Search at Vanderbilt-Ingram Cancer Center
Vorinostat in Preventing Graft Versus Host Disease in Children, Adolescents, and Young Adults Undergoing Blood and Bone Marrow Transplant
Multiple Cancer Types
This phase I/II trial studies the side effects and best dose of vorinostat in preventing graft versus host disease in children, adolescents, and young adults who are undergoing unrelated donor blood and bone marrow transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells, called graft-versus-host disease. During this process, chemicals (called cytokines) are released that may damage certain body tissues, including the gut, liver and skin. Vorinostat may be an effective treatment for graft-versus-host disease caused by a bone marrow transplant.
Hematologic,
Pediatric Leukemia,
Pediatric Lymphoma
I/II
Kitko, Carrie
NCT03842696
VICCPED2133
Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment
Multiple Cancer Types
Clinical study to investigate the efficacy and safety of savolitinib in combination with
osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated,
MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed
on treatment with Osimertinib.
osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated,
MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed
on treatment with Osimertinib.
Lung,
Non Small Cell
III
Iams, Wade
NCT05261399
VICCTHO2219
FHD-286 as Monotherapy or Combination Therapy in Subjects With Advanced Hematologic Malignancies
Multiple Cancer Types
This Phase 1, multicenter, open-label, dose escalation study is designed to assess the
safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical
activity of FHD-286 administered orally as monotherapy or combination therapy, in subjects
with advanced hematologic malignancies.
safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical
activity of FHD-286 administered orally as monotherapy or combination therapy, in subjects
with advanced hematologic malignancies.
Leukemia,
Myelodysplastic Syndrome,
Phase I
I
Kishtagari, Ashwin
NCT04891757
VICCHEMP2138
A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)
Lymphoma
Lymphoma
The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and
expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in
combination with standard of care options for the treatment of rrDLBCL. This study will be
divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will
enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in
combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx
with respect to progression-free survival (PFS) per Lugano response criteria by blinded
independent review committee (BICR); and that ZV in combination with bendamustine rituximab
(BR) is superior to BR with respect to PFS per Lugano response criteria by BICR.
expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in
combination with standard of care options for the treatment of rrDLBCL. This study will be
divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will
enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in
combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx
with respect to progression-free survival (PFS) per Lugano response criteria by blinded
independent review committee (BICR); and that ZV in combination with bendamustine rituximab
(BR) is superior to BR with respect to PFS per Lugano response criteria by BICR.
Lymphoma
II/III
Baljevic, Muhamed
NCT05139017
VICCPCL2228
Nilotinib, Trametinib, and Dabrafenib for the Treatment of BRAF V600 Mutant Metastatic or Unresectable Melanoma
Multiple Cancer Types
This phase I trial is to find out the best dose, possible benefits and/or side effects of nilotinib given together with trametinib and dabrafenib in treating patients with BRAF V600 mutant melanoma that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Nilotinib, trametinib, and dabrafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nilotinib together with trametinib and dabrafenib may lower the chance of cancer growing or spreading.
Melanoma,
Phase I
I
Johnson, Douglas
NCT04903119
VICCMELP2274
Capecitabine Compared to Endocrine Therapy for the Treatment of Non-luminal A Hormone Receptor-Positive Metastatic Breast Cancer
Breast
Breast
This phase II trial compares the effect of capecitabine to endocrine therapy in patients with non-Luminal A hormone receptor-positive breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). In this study, patients submit a sample of tumor for testing to determine if their breast cancer is considered non-Luminal A. Only patients with non-Luminal A receive study treatment. In the future, doctors hope that this test can assist in picking the best treatment for patients with this type of cancer. Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Endocrine therapy is treatment that adds, blocks, or removes hormones. To slow or stop the growth of certain cancers (such as prostate and breast cancer), synthetic hormones or other drugs may be given to block the body's natural hormones. Giving capecitabine as compared to endocrine therapy may kill more tumor cells in patients with metastatic breast cancer.
Breast
II
Reid, Sonya
NCT05693766
VICCBRE2256
Evexomostat Plus Alpelisib and Fulvestrant in Women With the PIK3CA Mutation With HR+/Her2- Breast Cancer
The PIK3CA gene is frequently mutated in breast cancer, leading to disease aggressiveness and
patient mortality. Alpelisib, a small molecule that inhibits the activity of the PIK3CA gene
product PI3K, has demonstrated clinical benefit in cancer patients with this gene mutation.
However, hyperglycemia, an on-target toxicity associated with alpelisib that leads to
hyperinsulinemia, limits the drug's clinical efficacy and induces high grade hyperglycemia in
patients with baseline metabolic dysfunction, insulin resistance and/or elevated HbA1c.
Restoring insulin sensitivity and reduction in circulating concentrations of insulin have
been reported to improve the activity of alpelisib.
Evexomostat (SDX-7320) is a polymer-conjugate of a novel small molecule methionine
aminopeptidase 2 (MetAP2) inhibitor that has demonstrated the ability to reduce
alpelisib-induced hyperglycemia in multiple animal experiments and has demonstrated
synergistic anti-tumor activity independent of changes in glucose or insulin. Evexomostat was
well tolerated in a Phase 1 safety study in late-stage cancer patients and showed
improvements in insulin resistance for patients that presented with baseline elevated
insulin. Overall, the most common treatment-emergent adverse events with evexomostat (TEAEs)
were fatigue (44%), decreased appetite (38%), constipation and nausea (each 28%), and
diarrhea (22%). All other TEAEs occurred at an incidence <20%.
The purpose of this study is to characterize the safety of the triplet drug combination
(alpelisib, fulvestrant plus evexomostat), to test whether evexomostat, when given in
combination with alpelisib and fulvestrant will reduce the number and severity of
hyperglycemic events and/or reduce the number of anti-diabetic medications needed to control
the hyperglycemia for patients deemed at risk for alpelisib-induced hyperglycemia (baseline
elevated HbA1c or well-controlled type 2 diabetes), and to assess preliminary anti-tumor
efficacy and changes in key biomarkers and quality of life in this patient population.
patient mortality. Alpelisib, a small molecule that inhibits the activity of the PIK3CA gene
product PI3K, has demonstrated clinical benefit in cancer patients with this gene mutation.
However, hyperglycemia, an on-target toxicity associated with alpelisib that leads to
hyperinsulinemia, limits the drug's clinical efficacy and induces high grade hyperglycemia in
patients with baseline metabolic dysfunction, insulin resistance and/or elevated HbA1c.
Restoring insulin sensitivity and reduction in circulating concentrations of insulin have
been reported to improve the activity of alpelisib.
Evexomostat (SDX-7320) is a polymer-conjugate of a novel small molecule methionine
aminopeptidase 2 (MetAP2) inhibitor that has demonstrated the ability to reduce
alpelisib-induced hyperglycemia in multiple animal experiments and has demonstrated
synergistic anti-tumor activity independent of changes in glucose or insulin. Evexomostat was
well tolerated in a Phase 1 safety study in late-stage cancer patients and showed
improvements in insulin resistance for patients that presented with baseline elevated
insulin. Overall, the most common treatment-emergent adverse events with evexomostat (TEAEs)
were fatigue (44%), decreased appetite (38%), constipation and nausea (each 28%), and
diarrhea (22%). All other TEAEs occurred at an incidence <20%.
The purpose of this study is to characterize the safety of the triplet drug combination
(alpelisib, fulvestrant plus evexomostat), to test whether evexomostat, when given in
combination with alpelisib and fulvestrant will reduce the number and severity of
hyperglycemic events and/or reduce the number of anti-diabetic medications needed to control
the hyperglycemia for patients deemed at risk for alpelisib-induced hyperglycemia (baseline
elevated HbA1c or well-controlled type 2 diabetes), and to assess preliminary anti-tumor
efficacy and changes in key biomarkers and quality of life in this patient population.
Not Available
I/II
Rexer, Brent
NCT05455619
VICCBREP2271
First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia
Multiple Cancer Types
This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess
ziftomenib, a menin-MLL(KMT2A) inhibitor, in patients with relapsed or refractory acute
myeloid leukemia (AML) as part of Phase 1. In Phase 2, assessment of ziftomenib will continue
in patients with NPM1-m AML.
ziftomenib, a menin-MLL(KMT2A) inhibitor, in patients with relapsed or refractory acute
myeloid leukemia (AML) as part of Phase 1. In Phase 2, assessment of ziftomenib will continue
in patients with NPM1-m AML.
Leukemia,
Phase I
I/II
Savona, Michael
NCT04067336
VICCHEMP20122
Study of DF1001 in Patients With Advanced Solid Tumors
Multiple Cancer Types
DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell
activation signals to specific receptors on cancer cells. The study will occur in two phases.
The first phase will be a dose escalation phase, enrolling patients with various types of
solid tumors that express human epidermal growth factor receptor 2 (HER2). The second phase
will include a dose expansion using the best dose selected from the first phase of the study.
Multiple cohorts will be opened with eligible patients having either HER2 activated non-small
cell lung cancer, hormone receptor (HR) positive HER2 negative metastatic breast cancer, or
HER2 positive metastatic breast cancer. DF1001-001 will be administered as monotherapy or in
combination; combinations are DF1001 + nivolumab, DF1001 + Nab paclitaxel, and DF1001 +
sacituzumab govitecan-hziy.
activation signals to specific receptors on cancer cells. The study will occur in two phases.
The first phase will be a dose escalation phase, enrolling patients with various types of
solid tumors that express human epidermal growth factor receptor 2 (HER2). The second phase
will include a dose expansion using the best dose selected from the first phase of the study.
Multiple cohorts will be opened with eligible patients having either HER2 activated non-small
cell lung cancer, hormone receptor (HR) positive HER2 negative metastatic breast cancer, or
HER2 positive metastatic breast cancer. DF1001-001 will be administered as monotherapy or in
combination; combinations are DF1001 + nivolumab, DF1001 + Nab paclitaxel, and DF1001 +
sacituzumab govitecan-hziy.
Miscellaneous,
Phase I
I/II
Berlin, Jordan
NCT04143711
VICCPHI2064
(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
GIST
GIST
This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination
with sunitinib. This is a multi-part study that will enroll approximately 426 patients. Part
1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to
be used in subsequent parts in approximately 20 patients who have received at least one prior
line of therapy for GIST and 2) evaluating for drug-drug interactions between CGT9486 and
sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase
inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388
patients who are intolerant to, or who failed prior treatment with imatinib only and will
compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being
randomized in a 1:1 manner.
with sunitinib. This is a multi-part study that will enroll approximately 426 patients. Part
1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to
be used in subsequent parts in approximately 20 patients who have received at least one prior
line of therapy for GIST and 2) evaluating for drug-drug interactions between CGT9486 and
sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase
inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388
patients who are intolerant to, or who failed prior treatment with imatinib only and will
compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being
randomized in a 1:1 manner.
GIST
III
Davis, Elizabeth
NCT05208047
VICCSAR21116
