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Histone Deacetylase Inhibitor
Panobinostat for Rhabdoid Tumor (NORTH Trial)
Phase 2
Waitlist Available
Research Sponsored by Australian & New Zealand Children's Haematology/Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is evaluating the anti-tumor activity and side effects of panobinostat in treating patients with osteosarcoma, malignant rhabdoid tumor/atypical teratoid rhabdoid tumor (MRT/ATRT), and neuroblastoma.
Eligible Conditions
- Rhabdoid Tumor
- Atypical Teratoid/Rhabdoid Tumor
- Malignant Rhabdoid Tumor
- Pediatric Brain Tumor
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2012 Phase 3 trial • 41 Patients • NCT0103416388%
Diarrhoea
58%
Nausea
46%
Vomiting
35%
Fatigue
27%
Neutropenia
27%
Thrombocytopenia
27%
Oropharyngeal pain
23%
Headache
19%
Upper respiratory tract infection
19%
Nasopharyngitis
15%
Sinusitis
15%
Influenza like illness
15%
Pyrexia
15%
Decreased appetite
12%
Leukopenia
12%
Muscle spasms
12%
Depression
12%
Arthralgia
12%
Cough
12%
Dysgeusia
12%
Gastrooesophageal reflux disease
12%
Asthenia
8%
Urinary tract infection
8%
Mucosal dryness
8%
Herpes virus infection
8%
Back pain
8%
Polyneuropathy
8%
Paranasal sinus hypersecretion
8%
Abdominal pain upper
8%
Constipation
8%
Platelet count decreased
4%
Cellulitis
4%
Gastroenteritis salmonella
4%
Sinusitis bacterial
4%
Insomnia
4%
Non-cardiac chest pain
4%
Hypophosphataemia
4%
Pruritus
4%
Abdominal pain
4%
Chills
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Panobinostat (PAN)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Osteosarcoma [arm closed]Experimental Treatment1 Intervention
Group II: Neuroblastoma [arm closed]Experimental Treatment1 Intervention
Group III: Malignant Rhabdoid Tumor/Atypical Teratoid Rhabdoid TumorExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Panobinostat
2011
Completed Phase 3
~1560
Find a Location
Who is running the clinical trial?
Australian & New Zealand Children's Haematology/Oncology GroupLead Sponsor
6 Previous Clinical Trials
6,882 Total Patients Enrolled
National Health and Medical Research Council, AustraliaOTHER
166 Previous Clinical Trials
476,852 Total Patients Enrolled
Secura Bio, Inc.Industry Sponsor
8 Previous Clinical Trials
194 Total Patients Enrolled
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