Study Summary
This trial will assess the safety and efficacy of eltrombopag in increasing platelet counts in children undergoing chemotherapy for solid tumors.
Eligible Conditions
- Solid Tumors
- Childhood Solid Tumor
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 2 weeks after completion of chemotherapy
Week 2
Efficacy objectives
Through follow up after end of treatment
Safety objectives
Trial Safety
Phase-Based Safety
Side Effects for
Part 1: Eltrombopag
17%Nasopharyngitis
16%Rhinitis
13%Epistaxis
11%Upper respiratory tract infection
11%Cough
10%Headache
10%Abdominal pain
6%Aspartate Aminotransferase increased
6%Pyrexia
5%Vitamin D deficiency
5%Abdominal pain upper
5%Alanine Aminotransferase increased
5%Decreased appetite
5%Diarrhoea
5%Oropharyngeal pain
5%Rash
5%Toothache
3%Gingival bleeding
3%Blood creatinine increased
3%Activated partial thromboplastin time prolonged
3%Bronchitis
3%Blood alkaline Phosphatase increased
3%Contusion
3%Mouth haemorrhage
3%Nausea
3%Rhinorrhoea
3%Vomiting
2%Bulimia nervosa
2%Furuncle
2%Paraesthesia
2%Impetigo
2%Influenza like illness
2%Pain
2%Tongue haemorrhage
2%Bronchospasm
2%Dyspepsia
2%Menorrhagia
2%Somnolence
2%Constipation
2%Ear pain
2%Motion sickness
2%Tonsillar hypertrophy
2%Excoriation
2%Lice infestation
2%Viral pharyngitis
2%Cellulitis
2%Subcutaneous abscess
2%Back pain
2%Osteoporosis
2%Allergy to chemicals
2%Lip haemorrhage
2%Retinal vascular disorder
2%Soft tissue injury
2%Joint injury
2%Pharyngitis
2%Asthenia
2%Anaemia
2%Influenza
2%Gingivitis
2%Dermatitis allergic
2%Gastritis
2%Groin pain
2%Non-cardiac chest pain
2%Platelet count increased
2%Rash pruritic
2%Meningitis aseptic
2%Pneumonia
2%Pneumonia fungal
2%Alanine aminotransferase abnormal
2%Aspartate aminotransferase abnormal
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1 Treatment Group
Treatment group
1 of 1
Experimental Treatment
10 Total Participants · 1 Treatment Group
Primary Treatment: Eltrombopag · No Placebo Group · Phase 1
Treatment group
Drug
Experimental Group · 1 Intervention: Eltrombopag · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eltrombopag
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 weeks after completion of chemotherapy
Who is running the clinical trial?
Anjali PawarLead Sponsor
Anjali Pawar, MDPrincipal Investigator - University of California, Davis
University of California, Davis
Eligibility Criteria
Age 1 - 18 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have been diagnosed with certain types of solid tumors, including rare ones like rhabdomyosarcoma, Ewings sarcoma, osteosarcoma, and others such as brain tumors (e.g. medulloblastoma).
You are able to perform daily activities with minimal difficulty, with a performance status score of 80% or higher.
Your doctor expects you to live for at least 6 more months.
You can swallow pills or liquid medicine.
Your platelet count is lower than 150,000 per microliter.
To be part of the study, you need to meet all of the following requirements.
You are between 1 and 18 years old.
You are currently undergoing or scheduled to receive treatment for a solid tumor within the next 60 days.
Your kidneys are working properly, with a blood test showing normal levels of creatinine.
Your bilirubin level is not too high (less than or equal to 1.5 times the normal range).
References
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- Anjali Pawar 2021. "Pilot Trial of Eltrombopag in Patients Undergoing Chemotherapy for Malignant Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04485416.