Clinical Trials Search at Vanderbilt-Ingram Cancer Center
INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
Miscellaneous
Miscellaneous
This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and
tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in
combination with ruxolitinib in participants with MF who are transfusion-dependent or
presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and
expansion.
tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in
combination with ruxolitinib in participants with MF who are transfusion-dependent or
presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and
expansion.
Miscellaneous
I/II
Mohan, Sanjay
NCT04455841
VICCHEMP2051
A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With Select Solid Tumors
Multiple Cancer Types
The goal of this clinical trial is to evaluate the safety of TOS-358 in adults with select
solid tumors who meet study enrollment criteria. The main questions it aims to answer are:
1. what is the maximum tolerated dose and recommended dose for phase 2?
2. how safe and tolerable is TOS-358 at different dose levels when taken orally once or
twice per day?
solid tumors who meet study enrollment criteria. The main questions it aims to answer are:
1. what is the maximum tolerated dose and recommended dose for phase 2?
2. how safe and tolerable is TOS-358 at different dose levels when taken orally once or
twice per day?
Breast,
Cervical,
Gastrointestinal,
Gynecologic,
Head/Neck,
Lung,
Phase I,
Urologic
I
Berlin, Jordan
NCT05683418
VICC-DTPHI23103
A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML
Multiple Cancer Types
Study ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3. Phase 1 consists of
an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose
levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time)
followed by a Dose Expansion Stage (Stage B) of ASTX030. Phase 2 is a randomized open-label
crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a
randomized open-label crossover study comparing the final oral ASTX030 dose to SC
azacitidine. The duration of the study is expected to be approximately 48 months.
an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose
levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time)
followed by a Dose Expansion Stage (Stage B) of ASTX030. Phase 2 is a randomized open-label
crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a
randomized open-label crossover study comparing the final oral ASTX030 dose to SC
azacitidine. The duration of the study is expected to be approximately 48 months.
Leukemia,
Myelodysplastic Syndrome,
Phase I
I/II/III
Savona, Michael
NCT04256317
VICCHEMP19146
A Study of E7386 in Combination With Other Anticancer Drug in Participants With Solid Tumor
Multiple Cancer Types
The primary objective of this study is to assess the safety and tolerability and to determine
the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s).
the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s).
Gynecologic,
Liver,
Phase I
I
Heumann, Thatcher
NCT04008797
VICC-DTPHI23106
Niraparib and Dostarlimab as Neoadjuvant Treatment for Patients with BRCA-Mutated or PALB2-Mutated Stage I-III Breast Cancer
Breast
Breast
This phase II trial studies the effects of niraparib in combination with dostarlimab prior to surgery in treating BRCA-mutated or PALB2-mutated stage I-III breast cancer. Niraparib is a PARP inhibitor, which means that it blocks an enzyme (proteins that help chemical reactions in the body occur) in cells called PARP. PARP helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Dostarlimab stimulates the immune system by blocking the PD-1 pathway. The PD-1 pathway controls the bodys natural immune response, but for some types of cancer, the immune system does not work as it should and is prevented from attacking tumors. Dostarlimab works by blocking the PD-1 pathway, which may help your immune system identify and catch tumor cells. Giving niraparib in combination with dostarlimab may work better against the tumor and maximize tumor shrinkage before surgery.
Breast
II
Abramson, Vandana
NCT04584255
VICCBRE2190
Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer
Gastric/Gastroesophageal
Gastric/Gastroesophageal
This phase II trial studies the effect of the combination of ramucirumab and trifluridine/tipiracil or paclitaxel in treating patients with previously treated gastric or gastroesophageal junction cancer that has spread to other places in the body (advanced). Ramucirumab may damage tumor cells by targeting new blood vessel formation. Trifluridine/tipiracil is a chemotherapy pill and that may damage tumor cells by damaging their deoxyribonucleic acid (DNA). Paclitaxel may block cell growth by stopping cell division which may kill tumor cells. Giving ramucirumab and trifluridine/tipiracil will not be worse than ramucirumab and paclitaxel in treating gastric or gastroesophageal junction cancer.
Gastric/Gastroesophageal
II
Gibson, Mike
NCT04660760
VICCGI2168
Phase 1b Combo w/ Ribociclib and Alpelisib
Multiple Cancer Types
This is a Phase 1b open-label, 2-part study in 2 treatment groups. The 2 treatment groups are
as follows:
Treatment Group 1: OP-1250 in combination with ribociclib (KISQALI, Novartis Pharmaceuticals
Corporation).
Treatment Group 2: OP-1250 in combination with alpelisib (PIQRAY, Novartis Pharmaceuticals
Corporation).
as follows:
Treatment Group 1: OP-1250 in combination with ribociclib (KISQALI, Novartis Pharmaceuticals
Corporation).
Treatment Group 2: OP-1250 in combination with alpelisib (PIQRAY, Novartis Pharmaceuticals
Corporation).
Breast,
Phase I
I
Nunnery, Sara
NCT05508906
VICCBREP2267
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Multiple Cancer Types
The goal of this clinical study is to learn more about the long-term safety, effectiveness
and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel,
KITE-222, KITE-363, KITE-439, KITE-585, and KITE-718, in participants of Kite-sponsored
interventional studies.
and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel,
KITE-222, KITE-363, KITE-439, KITE-585, and KITE-718, in participants of Kite-sponsored
interventional studies.
Hematologic,
Leukemia,
Lymphoma,
Pediatric Leukemia,
Pediatric Lymphoma
N/A
Kassim, Adetola
NCT05041309
VICCCTT2170
A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules - A Multicenter Prospective Observational Pilot Study
Lung
Lung
This study is being done to evaluate a combined biomarker model for risk stratification of indeterminate pulmonary nodules.
Lung
N/A
Grogan, Eric
NCT06074133
VICC-EDTHO23230
Evaluation of Immunologic Response following COVID-19 Vaccination in Children, Adolescents, and Young Adults with Cancer
Pediatrics
Pediatrics
This study evaluates immunologic response following COVID-19 vaccination in children, adolescents, and young adults with cancer. Vaccines work by stimulating the bodys immune cells to respond against a specific disease. The immune response produces protection from that disease. Effects from cancer and from treatments for cancer can reduce the bodys natural disease fighting ability (called immunity). Factors such as vaccine type, timing of vaccine dosing related to treatment for cancer and number of vaccine doses or boosts (extra vaccine shots) may strengthen or diminish the bodys protective immune response. This study may help researchers learn more about how the bodys immune system responds to the COVID-19 vaccine when the vaccination is given during or after cancer treatment.
Pediatrics
N/A
Esbenshade, Adam
NCT05228275
COGACCL21C2