Pilot Trial of Eltrombopag in Patients Undergoing Chemotherapy for Malignant Solid Tumors (NCT04485416) | Clinical Trial Compass
SuspendedPhase 1
Pilot Trial of Eltrombopag in Patients Undergoing Chemotherapy for Malignant Solid Tumors
Stopped: PI discretion; suspended while CAPA is reviewed
United States10 participantsStarted 2021-07-16
Plain-language summary
Primary Objective: To assess safety of eltrombopag in pediatric patients undergoing intensive chemotherapy for malignant solid tumors.
Secondary Objectives: To assess the efficacy of eltrombopag in increasing platelet count up to 2 weeks after completion of chemotherapy in pediatric patients undergoing intensive chemotherapy for malignant solid tumors.
Hypothesis: The hypothesis is that eltrombopag an oral thrombopoietin receptor agonist will increase the platelet count safely and efficaciously in children having chemotherapy induced thrombocytopenia while on therapy for solid tumors.
Who can participate
Age range1 Year – 18 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.
✓. Currently receiving cancer directed therapy for solid tumor or scheduled to start receiving cancer directed therapy for solid tumor within 60 days.
✓. Karnofsky Performance Status (KPS) performance status of 80% or greater.
✓. Life expectancy ≥ 6 months.
✓. Ability to swallow liquid solution/suspensions or tablets/capsules
✓. Platelet count \< 150,000µL
✓. Blood chemistry levels defined by:
Exclusion criteria
✕. Patients with known with hematologic malignancy diagnosis.
What they're measuring
1
Safety objectives
Timeframe: Through follow up after end of treatment
✕. Patients with history of thromboembolic disease or history of thrombophilic risk factors.
✕. History or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the study such as uncontrolled or significant cardiac disease, including any of the following:
✕. Impaired cardiac function, defined as:
✕. Pregnant or lactating women.
✕. Subjects with liver enzymes 5x upper limit of normal or liver cirrhosis (as determined by the investigator).
✕. Patients with known history of HIV positivity.