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Gastrointestinal Stromal Tumors clinical trials

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NCT ID: NCT02800330 Completed - Clinical trials for Colorectal Neoplasms

The Effects of the Proton Pump Inhibitor Esomeprazole on the Bioavailability of Regorafenib

REGORA
Start date: May 2016
Phase: Phase 4
Study type: Interventional

Regorafenib is a novel oral multi-kinase inhibitor which targets angiogenic, stromal and oncogenic receptor tyrosine kinases. It is currently registered for GIST and mCRC. When regorafenib is co-administered with an acid suppressive agent, the intra-gastric pH increases, and as a result the equilibrium of ionized/non-ionized regorafenib may shift to the less soluble non-ionized form which reduces regorafenib bioavailability and exposure. Since proton pump inhibitors (PPIs) are often used during regorafenib therapy, this drug-drug interaction (DDI) confronts pharmacists and oncologists with challenges in clinical practice. In this study the investigators will therefore evaluate the impact of PPI-induced intra-gastric pH elevation on regorafenib pharmacokinetics in patients with GIST and mCRC.

NCT ID: NCT02712112 Completed - Clinical trials for Gastrointestinal Stromal Tumors (GISTs)

A Study of Intermittent Dosing Schedule of Imatinib in Patients With Tyrosine Kinase Inhibitor Refractory GISTs

Start date: March 16, 2016
Phase: Phase 2
Study type: Interventional

Recent preclinical study has suggested a potential possibility that imatinib might promote tumor growth in the presence of secondary resistance mutations [10]. This result imply that intermittent dosing schedule of imatinib rechallenge might be better than continuous dosing schedule in terms of controlling tumors harboring secondary resistance mutations. In addition, in these heavily pretreated patients, even mild grade of toxicity may significantly impair quality of life, and intermittent dosing schedule may have an advantage in this context. Therefore, investigators hypothesize that intermittent dosing schedule of imatinib rechallenge might be feasible and effective in patients with TKI-refractory GISTs. This study will assess the feasibility of intermittent imatinib dosing schedule in patients with GISTs who had failures from both imatinib and sunitinib.

NCT ID: NCT02686944 Completed - Clinical trials for Gastrointestinal Stromal Tumor

A Study to Evaluate the Safety of Intuvax Administered Intra-tumorally in Patients With Gastrointestinal Stromal Tumors

GIST
Start date: June 1, 2016
Phase: Phase 1
Study type: Interventional

The study is a prospective single armed, open label phase I study. Patients with advanced or metastatic GIST and tumor progression despite ongoing treatment with second, third or fourth line TKI treatment, and with at least one measureable tumor lesion, will be eligible for the study. A maximum of 12 patients will be included in this study. The patients will continue with TKI treatment until the 3 months follow up visit. If further tumor progression TKI will be withdrawn but if stable disease or objective response the patient will continue with TKI until progress. The investigational product Intuvax will be injected into a tumor lesion at two or three treatment occasions; day 1, 14 days (±3 days) after the first vaccination, and 28 days (±3 days) after the second vaccination (patient 7-12 only). Intuvax will be injected in a viable part of the tumor, using ultrasound-guided or CT technique for correct administration.

NCT ID: NCT02662478 Completed - Clinical trials for Gastrointestinal Stromal Tumors

Laparoscopic Resection of Large Gastric Stromal Tumors

Start date: June 2008
Phase: N/A
Study type: Observational

Despite laparoscopic surgical treatment has not been recommended in patients with gastric gastrointestinal stromal tumors (GIST) larger than 5 centimeter, but it continues to evolve rapidly to overcome the boundaries. Therefore the authors generated a morpho-anatomical classification system (MACS) adapted for primary gastric GISTs, by which they could plan to tailor the laparoscopic gastric resection appropriately. The aims of the study was to demonstrate the feasibility of laparoscopic surgery for primary gastric GISTs larger than 5 cm, to find out the accuracy and practicality of the MACS for the development a preoperative strategy and the extent to which this strategy overlaps with the reality.

NCT ID: NCT02638766 Completed - Clinical trials for Gastrointestinal Stromal Tumors

Single Agent Regorafenib in First-line for Metastatic/Unresectable KIT/PDGFR Wild Type GIST

REGISTRI
Start date: November 2015
Phase: Phase 2
Study type: Interventional

Evaluate the treatment with regorafenib in patients with metastatic and/or unresectable KIT/PDGFR wild type GIST in the first line setting.

NCT ID: NCT02607332 Completed - Clinical trials for Gastrointestinal Stromal Tumors

Paclitaxel in Patients With Metastatic or Advanced Gastrointestinal Stromal Tumors (GIST) After Failure to Imatinib and Sunitinib

Start date: November 2015
Phase: Phase 2
Study type: Interventional

With discovery of KIT mutations and the advent of KIT tyrosine kinase inhibitor imatinib (GlivecTM, Novartis), there has been substantial improvement in overall survival in patients with advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib (SuteneTM, Pfizer) showed activity as second-line therapy in GIST patients after failure with imatinib. However, virtually all patients will eventually progress or become intolerable after the first-line imatinib and the second-line sunitinib.

NCT ID: NCT02606097 Completed - Clinical trials for Gastrointestinal Stromal Tumour (GIST)

Regorafenib in GIST With Secondary C-KIT Exon 17 Mutation

Start date: April 2014
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to examine whether regorafenib treatment can help people with gastrointestinal stromal tumours (GIST) and have gene mutation on c-kit exon 17. The safety of regorafenib treatment is also examined.

NCT ID: NCT02574663 Completed - Colorectal Cancer Clinical Trials

TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors

Start date: September 11, 2015
Phase: Phase 1
Study type: Interventional

This is a Phase 1 multi-center study to assess the safety and efficacy of TGR-1202 as a single agent or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients with select relapsed or refractory solid tumors.

NCT ID: NCT02571036 Completed - Clinical trials for Gastrointestinal Stromal Tumors

A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies

Start date: November 2015
Phase: Phase 1
Study type: Interventional

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. All active patients (from both dose-escalation and expansion phases) will then transition into an extension phase.

NCT ID: NCT02508532 Completed - Clinical trials for Gastrointestinal Stromal Tumors (GIST)

(NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors

Start date: August 2015
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antineoplastic activity of avapritinib (formerly BLU-285), administered orally (PO), in adult patients with unresectable GIST or other relapsed or refractory solid tumors. The study consists of 2 parts, a dose-escalation part (Part 1) and an expansion part (Part 2).