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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



Nintedanib, Idarubicin Hydrochloride, and Cytarabine in Treating Patients with Relapsed or Refractory Acute Myeloid Leukemia

Leukemia

This phase I / II trial studies the side effects of nintedanib, idarubicin hydrochloride, and cytarabine and to see how well they work in treating patients with acute myeloid leukemia that has come back or does not respond to treatment. Nintedanib may stop the growth of tumor cells by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as idarubicin hydrochloride and cytarabine, 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 nintedanib, idarubicin hydrochloride, and cytarabine may work better in treating patients with acute myeloid leukemia.
Leukemia
I/II
Strickland, Stephen
NCT02665143
VICCHEM1689

SEL24 / MEN1703 in Patients With Acute Myeloid Leukemia

Leukemia

The purpose of the clinical trial is to identify the highest dose of SEL24 / MEN1703 drug with acceptable safety profile and that can be used in patients with Acute Myeloid Leukemia.
Leukemia
I/II
Strickland, Stephen
NCT03008187
VICCHEM16123

Study of INCB053914 in Subjects With Advanced Malignancies

This is an open-label, dose-escalation study of the proviral integration site of Moloney murine leukemia virus (PIM) kinase inhibitor INCB053914 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (monotherapy dose escalation) will evaluate safety and determine the maximum tolerated dose of INCB053914 monotherapy and the recommended phase 2 dose(s) (a tolerated pharmacologically active dose that will be taken forward into the remaining parts of the study). Part 2 (monotherapy dose expansion) will further evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of the recommended Phase 2 dose(s). Part 3 (combination dose finding) will evaluate safety of INCB053914 in combination with select standard of care (SOC) agents and will identify the optimal INCB053914 dose in combination with conventional SOC regimens to take forward into Part 4. Part 4 (combination dose expansion) will further evaluate the safety, efficacy and pharmacokinetics of the recommended Phase 2 dose combination(s).
Not Available
I/II
Savona, Michael
NCT02587598
VICCHEM1592

Study of the Safety, Tolerability and Efficacy of KPT-8602 in Patients With Relapsed / Refractory Cancer Indications

Multiple Myeloma

This is a first-in-human, multi-center, open-label clinical study with separate dose escalation (Phase 1) and expansion (Phase 2) stages to assess preliminary safety, tolerability, and efficacy of the second generation oral XPO1 inhibitor KPT-8602 in patients with relapsed / refractory multiple myeloma (MM), metastatic colorectal cancer (mCRC), metastatic castration resistant prostate cancer (mCRPC), and higher risk myelodysplastic syndrome (HR-MDS). Dose escalation and dose expansion may be included for all parts of the study as determined by ongoing study results. This study is currently closed for enrollment for patients with relapsed / refractory multiple myeloma (MM), metastatic or colorectal cancer (mCRC), and metastatic castration resistant prostate cancer (mCRPC).
Multiple Myeloma
I/II
Cornell, Robert
NCT02649790
VICCHEM15112

Study Evaluating KTE-C19 in Pediatric and Adolescent Subjects With Relapsed / Refractory B-precursor Acute Lymphoblastic Leukemia

Pediatric Leukemia

The primary objectives of this study are to evaluate the safety and efficacy of KTE-C19 in pediatric and adolescent participants with relapsed / refractory (r / r) B-precursor acute lymphoblastic leukemia (ALL).
Pediatric Leukemia
I/II
Kitko, Carrie
NCT02625480
VICCPED15143

A Study Evaluating KTE-X19 in Adult Subjects With Relapsed / Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3)

The primary objectives of this study are to determine the safety and efficacy of KTE-X19 adult participants with relapsed / refractory (r / r) B-precursor acute lymphoblastic leukemia (ALL).
Not Available
I/II
Oluwole, Olalekan
NCT02614066
VICCBMT15150

A Trial of TAK-788 (AP32788) in Non-small Cell Lung Cancer (NSCLC)

Multiple Cancer Types

The purpose of this phase 1 / 2 study is to evaluate the safety, recommended phase 2 dose (RP2D), dose limiting toxicities (DLTs), maximum tolerated dose (MTD), pharmacokinetics of oral TAK-788, anti-tumor activity of TAK-788 in participants with NSCLC with epidermal growth factor receptor (EGFR) or human epidermal growth factor 2 (HER2), and anti-tumor activity of TAK-788 in participants with solid tumors other than NSCLC with EGFR or HER2 mutations, and to explore relationship between tumor and / or plasma biomarkers, and TAK-788 efficacy, safety, and / or cytochrome P450 3A (CYP3A) induction. The study will also determine the efficacy of TAK-788 in participants with locally advanced metastatic NSCLC harboring EGFR in-frame exon 20 insertion mutations who have received at least 1 prior line of therapy for locally advanced or metastatic NSCLC.
Lung, Non Small Cell
I/II
Horn, Leora
NCT02716116
VICCTHO1614

An Open-Label, Dose-Escalation / Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies

Multiple Cancer Types

This is an open-label, dose-escalation / dose-expansion study of INCB059872 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (mono therapy dose escalation) will determine the recommended dose(s) of INCB059872 for dose expansion, based on maximum tolerated dose and / or a tolerated pharmacologically active dose. Part 2 (dose expansion) will further determine the safety, tolerability, efficacy, PK, and PD of the selected monotherapy dose(s) in AML / MDS, SCLC, myelofibrosis, Ewing sarcoma, and poorly differentiated neuroendocrine tumors. Part 3 will determine the recommended dose(s) of INCB059872 in combination with azacitadine and all-trans retinoic acid in AML and in combination with nivolumab in SCLC. Part 4 will further determine the safety, tolerability, efficacy, PK, and PD of the selected combination dose(s) in Part 3.
Hematologic, Leukemia, Lung, Miscellaneous, Small Cell
I/II
Savona, Michael
NCT02712905
VICCHEMP1615

A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley)

This is a Phase 1b / 2 dose-optimization study to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of avelumab (MSB0010718C) in combination with other cancer immunotherapies in patients with locally advanced or metastatic solid tumors. The primary purpose is to assess the safety and early signs of efficacy of various avelumab combinations with other cancer immunotherapies, optimizing dosing regimens as appropriate, in a limited series of indications.
Not Available
I/II
Johnson, Douglas
NCT02554812
VICCMD1636

Cisplatin, Romidepsin and Nivolumab in Treating Patients with Locally Recurrent or Metastatic Triple Negative Breast Cancer

Breast

This phase I / II trial studies the side effects and best dose of romidepsin when given together with cisplatin and nivolumab, to see how well they work in treating patients with triple negative breast cancer that has come back at or near the same place as the original (primary) tumor, usually after a period of time during which the cancer could not be detected or spread to other parts of the body. Romidepsin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, 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. Romidepsin may also help cisplatin work better. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving romidepsin together with cisplatin and nivolumab may be a better treatment for tripe negative breast cancer.
Breast
I/II
Abramson, Vandana
NCT02393794
VICCBRE1674

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