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Eltrombopag for Childhood Cancer (CCPO011 Trial)
Phase 1
Recruiting
Led By Anjali Pawar, MD
Research Sponsored by Anjali Pawar
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky Performance Status (KPS) performance status of 80% or greater.
Persons aged ≥ 1 to ≤18 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks after completion of chemotherapy
Awards & highlights
CCPO011 Trial Summary
This trial will assess the safety and efficacy of eltrombopag in increasing platelet counts in children undergoing chemotherapy for solid tumors.
Who is the study for?
This trial is for children aged 1 to 18 with solid tumors like sarcomas, liver cancer, or brain tumors. They should be undergoing or about to start chemotherapy and have a life expectancy of at least 6 months. Kids must be able to swallow pills, have a platelet count under 150,000µL, and their kidneys and liver should work within certain limits.Check my eligibility
What is being tested?
The trial tests Eltrombopag's safety in kids getting chemo for solid tumors. It aims to see if this drug can safely raise platelet counts during treatment. The study will monitor the effects up to two weeks after chemo ends.See study design
What are the potential side effects?
Eltrombopag may cause side effects such as headaches, digestive issues, fatigue, liver problems, and increased risk of blood clots. Children might also experience reactions where they feel dizzy or have trouble breathing.
CCPO011 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly self-sufficient and active.
Select...
I am between 1 and 18 years old.
Select...
I can swallow liquids, tablets, or capsules.
CCPO011 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through follow up after end of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through follow up after end of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety objectives
Secondary outcome measures
Efficacy objectives
Side effects data
From 2014 Phase 3 trial • 92 Patients • NCT0152090917%
Nasopharyngitis
16%
Rhinitis
13%
Epistaxis
11%
Upper respiratory tract infection
11%
Cough
10%
Headache
10%
Abdominal pain
6%
Pyrexia
6%
Aspartate Aminotransferase increased
5%
Decreased appetite
5%
Alanine Aminotransferase increased
5%
Vitamin D deficiency
5%
Abdominal pain upper
5%
Oropharyngeal pain
5%
Rash
5%
Toothache
5%
Diarrhoea
3%
Activated partial thromboplastin time prolonged
3%
Blood alkaline Phosphatase increased
3%
Blood creatinine increased
3%
Bronchitis
3%
Contusion
3%
Gingival bleeding
3%
Mouth haemorrhage
3%
Nausea
3%
Rhinorrhoea
3%
Vomiting
2%
Soft tissue injury
2%
Constipation
2%
Groin pain
2%
Furuncle
2%
Cellulitis
2%
Retinal vascular disorder
2%
Dyspepsia
2%
Osteoporosis
2%
Pneumonia fungal
2%
Ear pain
2%
Allergy to chemicals
2%
Paraesthesia
2%
Gingivitis
2%
Excoriation
2%
Rash pruritic
2%
Impetigo
2%
Anaemia
2%
Dermatitis allergic
2%
Influenza like illness
2%
Lip haemorrhage
2%
Menorrhagia
2%
Viral pharyngitis
2%
Pneumonia
2%
Influenza
2%
Joint injury
2%
Lice infestation
2%
Motion sickness
2%
Pharyngitis
2%
Platelet count increased
2%
Somnolence
2%
Subcutaneous abscess
2%
Tongue haemorrhage
2%
Tonsillar hypertrophy
2%
Meningitis aseptic
2%
Alanine aminotransferase abnormal
2%
Aspartate aminotransferase abnormal
2%
Gastritis
2%
Asthenia
2%
Back pain
2%
Bronchospasm
2%
Bulimia nervosa
2%
Non-cardiac chest pain
2%
Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Placebo
Part 1: Eltrombopag
Part 2: Eltrombopag
CCPO011 Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment groupExperimental Treatment1 Intervention
Subjects will receive eltrombopag
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eltrombopag
FDA approved
Find a Location
Who is running the clinical trial?
Anjali PawarLead Sponsor
Anjali Pawar, MDPrincipal Investigator - University of California, Davis
University of California, Davis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am mostly self-sufficient and active.I am between 1 and 18 years old.I am currently undergoing or will start treatment for my solid tumor within 60 days.Your doctor expects you to live for at least 6 more months.Your kidneys are working properly, with a blood test showing normal levels of creatinine.I have been diagnosed with a specific type of solid tumor cancer.Your platelet count is lower than 150,000 per microliter.Your bilirubin level is not too high (less than or equal to 1.5 times the normal range).I can swallow liquids, tablets, or capsules.To be part of the study, you need to meet all of the following requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment group
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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