Safety and Efficacy Study for Solid Tumor Patients Treated With Eltrombopag
Summary
The present study is a randomized, blinded, placebo-controlled, two-Phase, sequential cohort, dose finding study to assess the safety and efficacy of eltrombopag in patients with solid tumors receiving gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin. Phase I of the study will examine safety and tolerability of various doses of eltrombopag to identify a dose and schedule eltrombopag. Phase II will confirm that the chosen dose and schedule of eltrombopag from Phase I can deliver clinically meaningful benefit(s) to thrombocytopenic patients by improving platelet numbers.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
Conditions
Thrombocytopaenia
Intervention
Placebo, Eltrombopag olamine
Location
GSK Investigational Site
Bay Pines
Florida
United States
33744
Status
Recruiting
Source
GlaxoSmithKline
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01147809
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Placebo Effect
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Clinical Trials
EXTEND (Eltrombopag Extended Dosing Study)
An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have pre...
This study will evaluate the safety and tolerability of eltrombopag in the treatment of low platelet counts in adult subjects with advanced myelodysplastic syndrome (MDS) or secondary acut...
Eltrombopag and the Bcl-xL Pathway in Idiopathic Thrombocytopenic Purpura (ITP)
The purpose of this study is to further evaluate the effects that eltrombopag has on platelets in subjects with chronic ITP. Eltrombopag is approved by the Food and Drug Administration (FD...
Eltrombopag for Post Transplant Thrombocytopenia
The goal of this clinical research study is to learn if eltrombopag can help to improve platelet counts in patients with low platelets after they have had a stem cell transplant. The safet...
Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
An open-label, dose-adjustment extension study to evaluate the safety and efficacy of eltrombopag for treatment of subjects with ITP who have previously been enrolled in the eltrombopag tr...
PubMed Articles
BACKGROUND: Eltrombopag is an oral thrombopoietin receptor agonist for the treatment of thrombocytopenia. We aimed to compare the response to once daily eltrombopag versus placebo in patients with chr...
Abstract Objectives: Eltrombopag, an oral, nonpeptide thrombopoietin receptor agonist, has been shown to increase platelet counts in adults with chronic immune thrombocytopenia and chronic hepatitis C...
Eltrombopag before Procedures in Patients with Cirrhosis and Thrombocytopenia.
To the Editor: Afdhal et al. (Aug. 23 issue)(1) used eltrombopag to increase the platelet count and reduce the need for transfusion in patients with cirrhosis who were undergoing elective invasive pro...
Eltrombopag before Procedures in Patients with Cirrhosis and Thrombocytopenia.
To the Editor: Afdhal et al. (Aug. 23 issue)(1) used eltrombopag to increase the platelet count and reduce the need for transfusion in patients with cirrhosis who were undergoing elective invasive pro...
Eltrombopag before Procedures in Patients with Cirrhosis and Thrombocytopenia.
To the Editor: Afdhal et al. (Aug. 23 issue)(1) used eltrombopag to increase the platelet count and reduce the need for transfusion in patients with cirrhosis who were undergoing elective invasive pro...
