View clinical trials related to Gastrointestinal Stromal Tumors.
Filter by:The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice
The treatment of advanced GIST patients is based on imatinib followed with sunitinib in case of resistance/intolerance. However, the median progression-free survival (PFS) on sunitinib is frequently short, and after failure with both imatinib and sunitinib, treatment remains controversial. Previous studies on GISTs have linked 9p21 alterations to tumor progression (El-Rifai et al. 2000; Kim et al., 2000; Schneider-Stock et al., 2003; Schneider-Stock et al., 2005; Romeo et al. 2009; Haller et al., 2008) but the driver gene was not positively identified (CDKN2A, CDKN2B, or MTAP) (Astolfi et al., 2010; Belinsky et al., 2009; Perrone et al., 2005; Assamaki et al. 2007; Huang et al., 2009). A recent study has shown that homozygous 9p21 deletions target CDKN2A and more specifically p16INK4a 4. Most of the CINSARC genes are known to be under the transcriptional control of E2F. RB1 sequesters E2F, which is released from the complex upon RB1 phosphorylation by CDK4. CDK4 is, in turn, inhibited by p16INK4a. Hence, we hypothesize that alteration of the restriction point via deletion of p16INK4a (and more rarely of RB1: 20% of cases) gene in GISTs is likely to be a causative event that leads to the overexpression of CINSARC genes, which in turn induce chromosome instability and ultimately metastasis. Low p16INK4a expression was associated with response to PD-0332991 in several in vitro tumor model(Konecny et al. 2011; Katsumi et al. 2011; Finn et al. 2009). Considering our molecular data, we believed that PD-0332991 warrants clinical investigation in advanced gastrointestinal stromal tumors with alteration of p16INK4a. This alteration is detectable by comparative genomic hybridization which is a technique highly manageable in the context of routine clinical care and clinical trial. Main objective was to assess the antitumor activity of PD-0332991 in terms of non-progression at 16 weeks (after centralized review) in patients with documented disease progression while on therapy with imatinib and sunitinib for unresectable and/or metastatic GIST.
The purpose of this study is to evaluate the efficacy and safety of ponatinib in participants with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) following failure of prior tyrosine kinase inhibitor (TKI) therapy.
Gastrointestinal stromal tumors (GISTs) are a form of sarcoma and the most common sarcoma tumors of the gastrointestinal tract. The limited clinical experience suggests that GIST patients may benefit from neo-adjuvant therapy from primary GIST. This is a prospective, multicenter, open, observational study in evaluation of safety and efficacy of imatinib compared with that of historical data for locally unresectable advanced GIST without metastasis. The study will include an up to 28-day screening period, followed by receiving imatinib mesylate (400 mg/day) for at least 6-12 months and followed up for 3 years after surgery.
The purpose of this study is to collect and assess long-term safety of nilotinib in patients who are on nilotinib treatment in a Novartis-sponsored, Oncology CD&MA study and are benefiting from the treatment as judged by the investigator.
Endoscopic ultrasound (EUS) is a well-established tool for the diagnosis and staging of many gastrointestinal conditions, including but not limited to, malignant and pre-malignant neoplasms of the pancreas, esophagus, rectum, and submucosal tumors developing along the gastrointestinal tract. EUS is the most sensitive test for the detection of focal lesions within the pancreas and is the most accurate method for diagnosing pancreas cancer. A biopsy method for tissue sampling via EUS called fine needle aspiration (FNA) was developed that enables a small needle to be passed into the lesion of interest under ultrasound guidance, obtaining cellular material for cytology. EUS-FNA is currently recommended for the diagnosis of cystic and solid mass lesions within and adjacent to the gastrointestinal tract. Yet in certain clinical circumstances, it is more desirable and sometimes necessary to obtain a core tissue biopsy for histology rather than the cellular material for cytology obtained with EUS-FNA. Furthermore, histology may generally increase the diagnostic yield of EUS-FNA compared to cytology. It is with these aims in mind that a new type of needle, the fine needle biopsy (EUS-FNB) device was developed to enable core tissue sampling. Since a comparison of these to methods has yet to be made, the aim of this study is to perform a direct comparison of the sampling adequacy and diagnostic yield of the new EUS-FNB needle with the conventional EUS-FNA needle.
Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved. The Echotip Procore (Cook Medical) core biopsy needle (ETP), has been demonstrated to provide excellent efficacy for core biopsy samples. Final diagnostic yield using this needle ranges from 80-90% and appears to be significantly greater than EUS-FNA for lesions requiring histology for diagnosis. However, there is currently only limited data from prospective studies comparing EUS-FNA to EUS-FNB with the ETP needle. The investigators propose a randomized, prospective, cross-over study comparing diagnostic accuracy of EUS-FNA to EUS-FNB.
1. Investigational Product 1. Imatinib mesylate tablet 400 mg 2. Glivec film-coated tablet 100 mg (Comparator) 2. Expected target disease 1. chronic myeloid leukemia 2. Gastrointestinal stromal tumors 3. Study design : Randomized, open-label, single dose, two-period, two-way, crossover study 1. 36 healthy subjects, 2 groups (18 subjects/group) 2. 2 Period (either 1-a(1 tablet) or 1-b(4 tablet)) 3. wash-out period : 14 days 4. Evaluation on pharmacokinetics(PKs) and safety 1. PKs : Cmax, AUClast, Tmax, AUCinf, t1/2 2. safety : adverse events, physical examination, vital sign, ECG, Laboratory test 5. Statistical method 1. Demography Characteristics 2. Pharmacokinetic parameters 3. Safety data
This phase I trial studies the side effects and best dose of ipilimumab and imatinib mesylate in treating patients with solid tumors that have spread to other places in the body or cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ipilimumab and imatinib mesylate may work better in treating patients with solid tumors.
The purpose of this study is to determine a maximum tolerated dose and/or recommended phase 2 dose of a combination of imatinib and BYL719 in the treatment of 3rd line GIST patients.