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
Morgan, David
NCT05139017
VICCPCL2228
Evaluation of SNDX-5613 in Participants With Colorectal Cancer and Other Solid Tumors
Phase I
Phase I
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor
activity of SNDX-5613 in participants with colorectal cancer (CRC) or other solid tumors who
have failed at least 1 prior line of therapy.
activity of SNDX-5613 in participants with colorectal cancer (CRC) or other solid tumors who
have failed at least 1 prior line of therapy.
Phase I
I/II
Ciombor, Kristen
NCT05731947
VICCPHI22111
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
A Randomized Study Investigating Preoperative Chemotherapy Followed by Surgery versus Surgery Alone in Patients with High Risk Retroperitoneal Sarcoma, STRASS2 Trial
Sarcoma
Sarcoma
This phase III trial compares the effect of adding chemotherapy (doxorubicin or epirubicin hydrochloride [epirubicin] with ifosfamide or dacarbazine) before standard surgery versus surgery alone in improving long-term survival in patients with retroperitoneal sarcomas that are able to be removed by surgery (resectable). Chemotherapy drugs, such as doxorubicin, epirubicin, ifosfamide, and dacarbazine, 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 chemotherapy before surgery may make the tumor smaller and easier to remove and may increase patient survival, compared to surgery alone.
Sarcoma
III
Davis, Elizabeth
NCT04031677
VICC-NTSAR23088
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
(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
A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis
Hematologic
Hematologic
A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care
compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.
compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.
Hematologic
III
Baljevic, Muhamed
NCT04973137
VICCPCL22109
