Masitinib in Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)
Gastro-intestinal Stromal TumoursThe objective is to evaluate the efficacy and safety of AB1010 at 7.5 mg/kg/day in the treatment of non pre-treated, inoperable patients with locally advanced/metastatic GIST.
Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST)...
Gastrointestinal Stromal TumorsA randomized, double-blind, placebo-controlled phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib. The study is composed of 3 periods: A Screening Period, a Treatment Period, and a Survival Follow up Period. Subjects randomized to be treated with regorafenib will receive 160 mg po od for 3 weeks of every 4 week (28 day) cycle (ie, 3 weeks on/1 week off). In addition subjects will receive best supportive care which excludes any disease specific anti cancer therapy such as any kinase inhibitor, chemotherapy, radiation therapy, or surgery. Tumor assessment will be every 4 weeks for the first 3 months, every 6 weeks for the next 3 months (through month 6), and every 8 weeks until the end of treatment, or more frequently if clinically indicated. Tumor assessments include CT or MRI and will be performed until tumor progression is seen in a central radiology review. Subjects receiving placebo who experience disease progression may be offered active treatment. Subjects who experience progression during regorafenib treatment may continue open label treatment. All subjects will enter the Survival Follow-up Period upon discontinuation of randomized study treatment.
Efficacy of Pazopanib in Gastrointestinal Stromal Tumors (GIST)
GISTThe purpose of this study is to evaluate the antitumor activity of pazopanib in patients with metastatic and/or locally advanced unresectable Gastrointestinal Stromal Tumors (GIST) resistant to imatinib and sunitinib. This is a phase II, randomized, multicentre study.
Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib...
Gastrointestinal Stromal TumorsThis study will evaluate the preliminary efficacy of nilotinib in pretreated patients (Imatinib, Sunitinib) with unresectable or metastatic gastrointestinal stromal tumors.
Cytochrom p450 3A4 and 1A2 Phenotyping for the Individualization of Treatment With Sunitinib or...
Non Small-cell Lung CancerRenal-cell Cancer1 moreIt is well known that substantial interindividual variability of CYP3A4/1A2-phenotype activity is an important contributor to individual differences in the sensitivity to the frequently used tyrosine kinase inhibitors sunitinib and erlotinib. This study tests the potential for CYP-phenotyping to predict individual pharmacology and derive dosing algorithms for more tailored treatment of these drugs.
Phase II Study Aiming to Evaluate the Efficacy and Safety of Nilotinib Patients With Gastrointestinal...
Gastrointestinal Stromal Tumors (GIST)The mainstay of therapy for GISTs is surgical resection, however, recurrence is almost inevitable in high-risk tumors and secondary surgery or other salvage therapy has yielded poor outcome. The median survival for patients with unresectable or metastatic GIST is approximately 20 months, and for patients with local recurrence it is 9 to 12 months. Responses to chemotherapy have been at best 5%. The introduction of imatinib has dramatically changed the prognosis of these patients yielding response rates between 41% and 71% and an overall clinical benefit (tumor responses plus stable disease) ranging between 73% and 90%. However, resistance to imatinib may develop and represents a further clinical challenge. Sunitinib has recently been approved by the FDA for patients whose disease has progressed or who are intolerant to imatinib therapy. Patients with tumor progressing on sunitinib or another 2nd line agent have limited therapeutic alternatives. Reinstitution of imatinib, if possible, is considered an acceptable option for these patients because it may slow the rate of disease progression even in the setting of prior imatinib failure; however a more optimal 3rd line treatment is needed. AMN107 is a novel aminopyrimidine, available as an oral formulation that is ATP -competitive inhibitor of BCR-ABL,more potent than Imatinib. It inhibits proliferation and autophosphorylation of 32 out of 33 BCR-ABL point mutations. In addition AMN107 also inhibits PDGFRα,PDGFRβ, and KIT. Preliminary data from an ongoing Phase I study in imatinib-resistant GIST patients (CAMN107A2103) indicate that AMN107 alone (400 mg BID) and in combination with imatinib (imatinib 400 mg BID plus AMN107 200 mg QD and 400 mg QD) is well tolerated in this pre-treated patients.
An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal...
GISTThis study will examine the effect of BIIB021 on GIST growth and metabolism.
Ph II of Capecitabine, Carboplatin & Bevacizumab for Gastroesophageal Junction & Gastric Carcinoma...
Stomach CancerGastric (Stomach) Cancer2 moreTo investigate bevacizumab in combination with carboplatin and capecitabine for patients with unresectable or metastatic GEJ or gastric cancers. We hope that by adding bevacizumab to standard chemotherapy for this patient population we will improve Progression Free Survival by 90% over historical controls.
Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant...
Gastrointestinal NeoplasmsGastrointestinal Stromal TumorsTo investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.
Surgery in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor
Gastrointestinal Stromal TumorMetastatic CancerRATIONALE: Surgery may be an effective treatment for liver metastasis from a gastrointestinal stromal tumor. PURPOSE: This phase II trial is studying how well surgery works in treating patients with liver metastasis from a gastrointestinal stromal tumor.