Nilotinib in Advanced GIST
Summary
This is a phase II study of Nilotinib for patients with advanced GIST that can not be surgically removed. Patients are candidates for the study if their tumors have progressed on imatinib and sunitinib or if they were intolerant to these drugs. Patients may have received other investigational therapies as well. We are testing the benefit of nilotinib in advanced GIST looking at the length of time disease is controlled as well as the response of the disease to the drug.
Description
Nilotinib is an oral drug. The dose is 400 mg twice daily
Patients are evaluated every 8 weeks for disease response. Blood work is assessed for safety initially weekly, then every 4 weeks. Physical exams are performed initially weekly and then decreased to every 4 weeks after the firs month.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Gastrointestinal Stromal Tumors
Intervention
Nilotinib
Location
Fox Chase Cancer Center
Philadelphia
Pennsylvania
United States
19111
Status
Completed
Source
Fox Chase Cancer Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00782834
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:26:33-0400
Clinical Trials
Nilotinib Pharmacokinetics (PK) in Gastrointestinal Stromal Tumor (GIST)
In patients who are receiving nilotinib, nilotinib plasma levels will be measured after 1 month of nilotinib treatment. The relationship between surgery type and nilotinib pharmakokinetic ...
The purpose of this multicenter, single-arm, exact binomial single-stage, phase II trial is to evaluate the efficacy of Nilotinib in patients with unresectable or metastatic gastrointestin...
The study will evaluate the long term safety and efficacy of nilotinib versus current treatment in adults with gastrointestinal stromal tumors (GIST) who have either progressed or who are ...
The study will investigate the comparative efficacy and safety of two oral inhibitors of Kit and PDGFR: nilotinib 400 mg bid, a novel agent, and imatinib 400 mg bid, an approved agent with...
This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.
PubMed Articles
Management of gastrointestinal stromal tumors: A 10-year experience of a single surgical department.
Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumors of the digestive system. The primary location of GISTs is mainly the gastrointestinal system. Clinical symptoms are nonsp...
The main objective of the present study was to evaluate the significance of apoptosis in the Fletcher's risk classification for gastrointestinal stromal tumors (GISTs).
Melena as an unusual presentation of gastrointestinal stromal tumour, a case report.
Gastrointestinal Stromal Tumors (GISTs) are a rare slow growing malignancy, accounting for less than 1% of all gastrointestinal (GI) tract tumors. These tumors are usually discovered incidentally by e...
The role of surgical resection for patients with recurrent or metastatic gastrointestinal stromal tumors is still controversial. This meta-analysis aims to investigate the clinical outcomes of surgery...
Gastrointestinal stromal tumors: A clinical and histopathological presentation of 27 cases.
Gastrointestinal stromal tumors (GISTs) are mesenchymal tumors that express type 3 tyrosine kinase receptors and are thought to develop from the neoplastic transformation of the interstitial Cajal cel...
Medical and Biotech [MESH] Definitions
Endometrial Stromal Tumors
Neoplasms of the endometrial stroma that sometimes involve the MYOMETRIUM. These tumors contain cells that may closely or remotely resemble the normal stromal cells. Endometrial stromal neoplasms are divided into three categories: (1) benign stromal nodules; (2) low-grade stromal sarcoma, or endolymphatic stromal myosis; and (3) malignant endometrial stromal sarcoma (SARCOMA, ENDOMETRIAL STROMAL).
Gastrointestinal Stromal Tumors
All tumors in the GASTROINTESTINAL TRACT arising from mesenchymal cells (MESODERM) except those of smooth muscle cells (LEIOMYOMA) or Schwann cells (SCHWANNOMA).
Sex Cord-gonadal Stromal Tumors
Neoplasms derived from the primitive sex cord or gonadal stromal cells of the embryonic GONADS. They are classified by their presumed histogenesis and differentiation. From the sex cord, there are SERTOLI CELL TUMOR and GRANULOSA CELL TUMOR; from the gonadal stroma, LEYDIG CELL TUMOR and THECOMA. These tumors may be identified in either the OVARY or the TESTIS.
Imatinib Mesylate
A tyrosine kinase inhibitor and ANTINEOPLASTIC AGENT that inhibits the BCR-ABL kinase created by chromosome rearrangements in CHRONIC MYELOID LEUKEMIA and ACUTE LYMPHOBLASTIC LEUKEMIA, as well as PDG-derived tyrosine kinases that are overexpressed in gastrointestinal stromal tumors.
Gastrointestinal Neoplasms
Tumors or cancer of the GASTROINTESTINAL TRACT, from the MOUTH to the ANAL CANAL.
