Safety and Efficacy Study for Solid Tumor Patients Treated With Eltrombopag

Completed · Phase 2 · Has a placebo group

Conditions studied: Thrombocytopaenia

In brief

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 of 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.

Key facts

Study ID

NCT01147809

Run by

GlaxoSmithKline

People needed

130

Starts

2010-06-01

Expected to finish

2015-03-01

Last updated by the study team

2016-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects meeting any of the following criteria must not be enrolled in the study:
• Lactating females.
• Pre-existing cardiovascular disease (congestive heart failure, New York Heart Association [NYHA] Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation), unstable angina, or subjects with a QTc >450 msec (QTc >480 msec for subjects with Bundle Branch Block) at study entry, or myocardial infarction within the preceding 6 months. Subjects with a34 pacemaker or defibrillator are not excluded provided that their cardiac function is within normal ranges.
• Note: For patients with pre-existing NYHA Grade II cardiovascular disease, the investigator should consult with GSK medical monitor before enrolling the subject into the study.
• Patients with known factor V leiden, antiphospholipid antibody syndrome, prothrombin gene mutations, ATIII deficiency, protein C deficiency, protein S deficiency OR recent history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism) within the preceding 6 months.
• Note: for patients with known risk factors for thromboembolism e.g., diabetes, hypercholesterolemia, recent major surgery etc., the investigator should consult with GSK medical monitor before enrolling the patient into the study and all risk factors should be documented in the CRF.
• Prior surgery within two weeks before study randomization or radiotherapy (RT) within four weeks before study randomization. Subjects with prior surgery or RT are not permitted into the study unless they have completely recovered from surgery and/or acute RT toxicity except for alopecia.
• Note: Note: patients with minor surgeries or outpatient procedures (e.g. insertion of central venous catheter) are immediately allowed in the study provided that there were no complications from the procedure or surgery.
• History of prior radiotherapy to more than 20% bone marrow bearing sites.
• History of platelet agglutination abnormality, platelet disorders or dysfunction or bleeding disorder that prevents reliable measurement of platelet counts.
• Subjects with a history of CNS metastases or clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT or MRI brain scan unless properly treated. Subjects with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to randomization will be excluded.
• Treated brain metastases are defined
• Having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed.
• Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician.
• Note: if subject has performed a CT scan immediately prior to the screening period and CT could not be repeated, an MRI should be performed in the screening period to exclude the development of brain metastases and/or the progression of the pre-existing brain metastatic lesion(s).
• Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of investigational product in the study. Concurrent participation in another interventional clinical trial or administration of any investigational drug during the study is also not permitted.
• A known immediate or delayed hypersensitivity reaction or idiosyncrasy that, in the opinion of the Investigator or GSK Medical Monitor is due to drugs chemically related to eltrombopag or excipients (e.g. mannitol).
• Subjects with known Hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV). Subjects with Gilbert's Syndrome are permitted into the study.

Where it is running

• GSK Investigational Site — Hot Springs, Arkansas, United States
• GSK Investigational Site — Rancho Cucamonga, California, United States
• GSK Investigational Site — Norwich, Connecticut, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — New Port Richey, Florida, United States
• GSK Investigational Site — Rome, Georgia, United States
• GSK Investigational Site — Savannah, Georgia, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — Bethesda, Maryland, United States
• GSK Investigational Site — Rockville, Maryland, United States
• GSK Investigational Site — Columbia, Missouri, United States
• GSK Investigational Site — Las Vegas, Nevada, United States
• GSK Investigational Site — Cherry Hill, New Jersey, United States
• GSK Investigational Site — Albany, New York, United States
• GSK Investigational Site — Greensboro, North Carolina, United States
• GSK Investigational Site — Bend, Oregon, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States
• GSK Investigational Site — Wynnewood, Pennsylvania, United States
• GSK Investigational Site — Providence, Rhode Island, United States
• GSK Investigational Site — Providence, Rhode Island, United States
• GSK Investigational Site — Greenville, South Carolina, United States
• GSK Investigational Site — Arlington, Texas, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — Bedford, Texas, United States
• GSK Investigational Site — Sedona, Arizona, United States

Full record on ClinicalTrials.gov

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