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A Drug-drug Interaction Study of Avapritinib and Midazolam to Treat Unresectable or Metastatic Gastrointestinal Stromal Tumors and Other Advanced Solid Tumors
Jacksonville, FL
The purpose of this study is to investigate the effect of Avapritinib on the pharmacokinetics of Midazolam in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) or other advanced solid tumors.
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Early Detection of Broken Hearts in Cancer Patients
Rochester, MN
The early detection of Bevacizumab or Sunitinib caused cardiotoxicity using cardiac biomarkers and new Transthoracic Echocardiogram (TTE) techniques may allow the adjustment of treatment and/or the administration of prophylactic heart protective agents, prior to the development of irreversible cardiac dysfunction. We hypothesize that cardiac biomarkers, TVI/strain-derived indices will be able to accurately detect subtle cardiac injury at a time when conventional Left Ventricular Ejection Fraction (LVEF) remains normal. Additionally, we hypothesize that Endothelial Function Test (EndoPAT) testing can detect early endothelial dysfunction.
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A Study of Disease Risk Caused by Tumor Particles Getting into the Blood from Endoscopic Ultrasound Guided Fine Needle Aspiration
No Locations
The purpose of this study is to assess the risk for cancer spread caused by the leaking of tumor particles into the blood from the biopsy procedure endoscopic ultrasound guided fine needle aspiration.
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(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare CGT9486 in combination with sunitinib to treat gastrointestinal stromal tumors.
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A Study of DCC-2618 vs. Sunitinib in Advanced GIST Patients after Treatment with Imatinib
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 358 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off).
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A Study of XmAb ®18087 in Subjects With NET and GIST
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety and tolerability profile of XmAb18087 in subjects with advanced, well-differentiated neuroendocrine tumors (NET) of pancreatic, gastrointestinal, lung, and undetermined origin, and subjects with advanced gastrointestinal stromal tumors (GIST), and to identify the maximum tolerated dose (MTD) and/or recommended dose (RD) and schedule of XmAb18087 administered by intravenous (IV) dosing on Days 1, 8, 15, and 22 of each 28-day cycle in subjects with advanced NET and advanced GIST, separately.
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Expanded Access Program of Ripretinib (DCC-2618) for the Treatment of Patients With Advanced GIST
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to provide patients who have locally advanced unresectable or metastatic gastrointestinal stromal tumor (GIST) and have received treatment with at least 2 prior Food and Drug Administration (FDA)-approved therapies early access to ripretinib until such time that ripretinib becomes commercially available or the Sponsor chooses to discontinue the program.
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A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Sunitinib in Patients with Gastrointestinal Stromal Tumour After Progression with Imatinib
Jacksonville, FL; Rochester, MN
The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day
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Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies
Jacksonville, FL; Rochester, MN
This is a 2‑arm, randomized, placebo-controlled, double‑blind, international, multicenter study comparing the efficacy of DCC-2618 to placebo in patients who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients will be randomized in a 2:1 ratio to DCC‑2618 150 mg QD or placebo
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An Early Access Program (EAP) for Avapritinib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this expanded access program is to provide access to avapritinib until such time that avapritinib becomes available through other mechanisms or the Sponsor chooses to discontinue the program.
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A Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate in Patients With Advanced GIST
Jacksonville, FL
The purpose of this study is to evaluate the effect of Ripretinib on the pharmacokinetics of a CYP2C8 Substrate.
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A Study of THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Jacksonville, FL
The purpose of this study is to assess the safety, effectiveness, and pharmacokinetics of THE-630 in participants with advanced gastrointestinal stromal tumors (GIST).
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Collection of Tissue, Blood Samples, and/or Cystic Fluid in Patients with Benign, Premalignant and/or Malignant Gastrointestinal (GI) Disease
Scottsdale/Phoenix, AZ
The goal of this study is to establish and maintain a gastrointestinal disease biospecimen bank containing samples of neoplasms, normal tissue, blood and/or any other tissue or cystic fluid from patients undergoing a diagnostic or therapeutic procedure for gastrointestinal disease.
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A Study to Evaluate the Safety and Tolerability of DCC-2618 in Patients with Advanced Malignancies
Jacksonville, FL
This is a Phase 1, open-label, first-in-human (FIH) dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary antitumor activity of DCC-2618, administered orally (PO), in adult patients with advanced malignancies. The study consists of 2 parts, a dose-escalation phase and an expansion phase.
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(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs.
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Factors Contributing to Delay in Diagnosis of Bone/Soft Tissue Sarcoma
Rochester, MN
Information regarding the delay in diagnosis as well as the causes of the delay are lacking in the U.S. Specifically, we aim to identify patient factors and provider factors that contribute to delayed diagnosis of sarcoma.
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Collection of Sarcoma Tissue Study
Scottsdale/Phoenix, AZ
The goal of this study is to create a comprehensive system of tissue banking of samples from Mayo Clinic Arizona patients with a clinical diagnosis of sarcoma who will or have undergone a surgical procedure to remove the sarcoma. The tissue samples will be used for future research of sarcoma at Mayo Clinic and future research at Mayo Clinic to learn about, prevent, or treat other health problems.
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Study of the Safety, Pharmacokinetics and Efficacy of EDO-S101, in Patients With Advanced Solid Tumors
No Locations
Tinostamustine (EDO-S101) is a new chemical entity, an AK-DAC (a first-in-class alkylating deacetylase inhibiting molecule) that, in preclinical studies, has been shown to simultaneously improve access to the DNA strands within cancer cells, break them and block damage repair. This Phase 1/2 study will enroll patients with various advanced solid tumors.