Pilot Trial of Eltrombopag in Patients Undergoing Chemotherapy for Malignant Solid Tumors (CCPO011)
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|ClinicalTrials.gov Identifier: NCT04485416|
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : July 23, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor, Childhood Solid Tumor||Drug: Eltrombopag||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Single Arm Prospective Pilot Trial of Eltrombopag in Patients 1 Year to 18 Years of Age Undergoing Intensive Chemotherapy for Malignant Solid Tumors (CCPO011)|
|Actual Study Start Date :||July 16, 2021|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Treatment group
Subjects will receive eltrombopag
Eltrombopag is an orally administered small-molecule nonpeptide TPO-R agonist.
Other Name: Promacta
- Safety objectives [ Time Frame: Through follow up after end of treatment ]For safety our end point is liver enzymes ALT, AST up to 5 x upper limit of normal (ULN) in <80% of patients.
- Efficacy objectives [ Time Frame: 2 weeks after completion of chemotherapy ]For efficacy the end point is 6 of 10 patients respond to the study treatment by an increase in platelet counts by 20,000/μL and are able to proceed with their next cycle of chemotherapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04485416
|Contact: Stephanie Gam, BAfirstname.lastname@example.org|
|Contact: Annika Bryant, BAemail@example.com|
|United States, California|
|University of California Davis Health System, Comprehensive Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Anjali Pawar, MD 916-734-2781 firstname.lastname@example.org|
|Principal Investigator: Anjali Pawar, MD|
|Sub-Investigator: Marcio Malogolowkin, MD|
|Principal Investigator:||Anjali Pawar, MD||University of California, Davis|