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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



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 Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)

Lung

The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC. This study has multiple primary endpoints. The first primary completion date of Pathological Complete Response is anticipated to be reached April 2020. The completion date for all primary outcome measures is expected May 2023.
Lung
III
Horn, Leora
NCT02998528
VICCTHO1718

Methoxyamine, Cisplatin, and Pemetrexed Disodium in Treating Patients with Advanced Solid Tumors or Mesothelioma That Cannot Be Removed by Surgery or Mesothelioma That Is Refractory to Pemetrexed Disodium and Cisplatin or Carboplatin

Multiple Cancer Types

This phase I / II trial studies the side effects and the best dose of methoxyamine when given together with cisplatin and pemetrexed disodium and to see how well it works in treating patients with solid tumors or mesothelioma that have spread to other places in the body and usually cannot be cured or controlled with standard treatment (advanced), or mesothelioma that does not respond to pemetrexed disodium and cisplatin or carboplatin (refractory). Methoxyamine may shrink the tumor and may also help cisplatin and pemetrexed disodium work better by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as cisplatin and pemetrexed disodium, 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 methoxyamine together with cisplatin and pemetrexed disodium may be a better treatment for solid tumors or mesothelioma than methoxyamine and pemetrexed disodium.
Endocrine, Lung, Non Small Cell, Ovarian, Phase I
I/II
Horn, Leora
NCT02535312
VICCTHO1722

Long Term Follow-up for Early Detection of Lung Cancer in Current or Former Smokers

Lung

This research trial studies the long term follow-up for early detection of lung cancer in current or former smokers. Following up on smokers by collecting and analyzing specimens in the laboratory, performing chest computed tomography (CT) scans, as well as reviewing medical records may help doctors detect lung cancer at an earlier stage.
Lung
N/A
Massion, Pierre
NCT03181256
VICCTHO1730

Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors

Multiple Cancer Types

The purpose of this study is to evaluate the safety and effectiveness of this investigational drug, brigatinib (AP261136) in patients with advanced non-small cell lung cancer Non-small cell lung cancer (NSCLC) who have had first-line treatment for their cancer and it still got worse, even after, or while taking drugs called ALK inhibitors, or anti-cancer drugs that act on tumors. Some examples of these anti-cancer drugs are: KEYTRUDA® or ALECENSA®).
Lung, Non Small Cell
II
Horn, Leora
NCT02706626
VICCTHO1736

Tumor-Treating Fields Therapy in Preventing Brain Tumors in Patients with Extensive-Stage Small Cell Lung Cancer

Multiple Cancer Types

This trial studies how well tumor-treating fields therapy works in preventing brain tumors in patients with small cell lung cancer that has spread to other places in the body. Tumor-treating fields therapy involves the use of the NovoTTF-200A which delivers alternating electrical fields, or tumor treating fields, through ceramic discs placed on the head. This electric force may slow and / or reverse tumor growth by disrupting the way cancer cells grow.
Lung, Small Cell
N/A
Attia, Albert
NCT03607682
VICCTHO1747

Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors

Multiple Cancer Types

The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas. Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule). Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor's objective response rate. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue will also be collected for mesothelin expression testing and biomarker analyses.
Breast, Endocrine, Esophageal, Gastrointestinal, Lung, Non Small Cell, Pancreatic
I
Horn, Leora
NCT03102320
VICCPHI1742

M3541 in Combination With Radiotherapy in Subjects With Solid Tumors

Multiple Cancer Types

This dose-escalation study will evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and explore antitumor activity of M3541 in combination with fractionated palliative radiotherapy (RT) in subjects with solid tumors with malignant lesions in the thorax, abdominal cavity, head and neck region, or extremities likely to benefit from palliative RT.
Esophageal, Gastric/Gastroesophageal, Gastrointestinal, Head/Neck, Lung, Miscellaneous, Phase I
I
Not Available
NCT03225105
VICCPHI1748

Afatinib and Necitumumab in Treating Patients with EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer

Multiple Cancer Types

This phase I trial studies the side effects and best dose of afatinib and necitumumab and to see how well they work in treating patients with EGFR mutation positive non-small cell lung cancer that has spread to other places in the body. Afatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as necitumumab, may interfere with the ability of tumor cells to grow and spread. Giving afatinib and necitumumab may work better in treating patients with EGFR mutation positive non-small cell lung cancer.
Lung, Non Small Cell
I
Horn, Leora
NCT03054038
VICCTHO1684

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