A Study to Assess the Efficacy and Safety of Eltrombopag as a Rescue of Isolated Chemotherapy-ind… (NCT02093325) | Clinical Trial Compass
UnknownPhase 3
A Study to Assess the Efficacy and Safety of Eltrombopag as a Rescue of Isolated Chemotherapy-induced Thrombocytopenia
Taiwan83 participantsStarted 2014-03
Plain-language summary
The purpose of this study is evaluate the efficacy and safety of eltrombopag as a rescue of isolated chemotherapy-induced thrombocytopenia in patients with solid tumor .
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects aged ≥18 years
* Diagnosed with solid tumor
* On active chemotherapy with combined regimen
* A baseline platelet count of \<75,000/μL within 2 days of screening
* Hb ≧ 9.0 g/dL
* ANC ≧ 1,500/uL
* GOT and GPT ≤ 3 x ULN
* Serum bilirubin ≤ 1.5 x ULN
* Albumin ≥ 2.5 g/dL
* Adequate renal function for chemotherapy:
serum creatinine ≤ 1.5 × ULN (CTCAE Grade 1).
* Be able to take oral medicine
* ECOG performance ≤ 2
* Has a negative urine or serum pregnancy test at screening and is willing to use contraceptive measures during medication of this trial (Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, tubal ligation and post-menopausal status) for patients with childbearing potential
* Ability to participate and willingness to give written informed consent and to comply with the study restrictions
Exclusion Criteria:
* Single agent chemotherapy or not having chemotherapy
* Serious cardiac, cerebrovascular, or pulmonary disease that, in the opinion of the investigator, would preclude trial medication
* Severe GI tract obstruction that require continuous NG decompression
* Subjects with hemoglobinopathies, e.g. sickle cell anaemia, thalassemia major
* Any prior history of arterial or venous thrombosis
* Any disease condition associated with active bleeding or requiring anticoagulation, heparin or warfarin
* Pre-existing cardiac disease (congestive heart failure New York Heart Association (NYHA) G…