Canadian clinical trial registry

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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

71 results found

Title
Status

 

MS100070_0087 - Single-arm, Multicenter Phase I/Ib Study of Avelumab + Lenvatinib in Children With Primary CNS Tumors

Open

MS100070_0087 - Single-arm, Multicenter Phase I/Ib Study of Avelumab + Lenvatinib in Children With Primary CNS Tumors

Go to Health Care Provider version

DiagnosisCentral Nervous System (CNS) Tumours Study StatusOpen
PhaseI
Age2 Years to 18 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Avelumab (Given through IV Infusion, every 2 weeks) Drug: Lenvatinib (Given orally, daily)
Last Posted Update2022-04-25
ClinicalTrials.gov #NCT05081180
International Sponsor
EMD Serono Research & Development Institute, Inc.
Merck KGaA
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Ute Bartels
CHU Ste. Justine - Dr. Sebastien Perreault
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

NAIT Program 

nait.info@sickkids.ca

 

Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

In this study, researchers are trying to learn more about the safety of the combination of study medicines Avelumab and Lenvatinib, and how well they work for children and young people with central nervous system tumours where previous treatment have not worked.

If you/your child participate in this study, you/they will be asked to join one of the two parts.

Part 1 will help us learn the best dose of the drug to take, and in Part 2, we will use the information obtained in Part 1 to continue to give the study drug and monitor how it is working.

Inclusion Criteria
  • Patients must have a confirmed diagnosis of a high-grade brain tumour
  • Patients must be between the ages of 2-18 years old
  • Patients must have a cancer that has come back (relapsed) after a previous treatment
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours
  • Patients must have a willingness to complete clinical assessments throughout the study (electronic, paper and/or interviewer methods)

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

1200.120 - Phase I/II Open Label, Dose Escalation Trial to Determine the MTD, Safety, PK and Efficacy of Afatinib Monotherapy in Children Aged ≥1 Year to <18 Years With Recurrent/Refractory Neuroectodermal Tumours, Rhabdomyosarcoma and/or Other Solid Tumours With Known ErbB Pathway Deregulation Regardless of Tumour Histology

Closed to enrollment

1200.120 - Phase I/II Open Label, Dose Escalation Trial to Determine the MTD, Safety, PK and Efficacy of Afatinib Monotherapy in Children Aged ≥1 Year to <18 Years With Recurrent/Refractory Neuroectodermal Tumours, Rhabdomyosarcoma and/or Other Solid Tumours With Known ErbB Pathway Deregulation Regardless of Tumour Histology

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DiagnosisNeuroectodermal Tumors, Rhabdomyosarcoma, CNS tumors, Other brain tumours, Other solid tumors, PNET, Tumour with Erb pathway deregulationStudy StatusClosed to enrollment
PhaseI/II
AgeChild, Adult - (1 Year to 18 Years)RandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationOral
Last Posted Update2022-04-25
ClinicalTrials.gov #NCT02372006
International Sponsor
Boehringer Ingelheim
Principal Investigators for Canadian Sites
The Hospital for Sick Children – Dr. Vijay Ramaswamy
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

NAIT Program 

nait.info@sickkids.ca

 

 

 

Study Description

Some solid tumours and some brain tumours shares common a common feature that is called "deregulation of the ErbB-pathway". Afatinib is an drug, taken by mouth, that can block proteins from the ErbB-family and could be efficient in pediatric tumours with Erb pathway deregulation. 

The aim of this study is to find the maximum tolerated dose of afatinib, and to assess its activity against tumours.

Inclusion Criteria
  • Paediatric patients aged 1 year to <18 years at the time of informed consent
  • Diagnosis of HGG, DIPG, low grade astrocytoma, medulloblastoma/PNET, ependymoma, neuroblastoma, RMS and tumours with ErbB deregulation
  • Recurrent/refractory disease after they received at least one prior standard treatment regimen
  • No effective conventional therapy exists

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

GO42286 - A Phase I/II, Open-Label, Multicenter, Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Patients With ALK Fusion-Positive Solid or CNS Tumors for Whom Prior Treatment Has Proven to be Ineffective or for Whom There is No Satisfactory Treatment Available

Open

GO42286 - A Phase I/II, Open-Label, Multicenter, Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Patients With ALK Fusion-Positive Solid or CNS Tumors for Whom Prior Treatment Has Proven to be Ineffective or for Whom There is No Satisfactory Treatment Available

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DiagnosisALK Fusion-positive Solid or CNS TumorsStudy StatusOpen
PhaseI/II
Ageup to 17 YearsRandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationAlectinib: taken by mouth
Last Posted Update2022-04-25
ClinicalTrials.gov #NCT04774718
International Sponsor
Hoffmann-La Roche
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Vijay Ramaswamy
CHU Ste Justine - Dr. Nicholas Prud'homme
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

NAIT Program 

nait.info@sickkids.ca

 

Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

In this study, researchers are trying to learn more about how safe the study medicine alectinib is, and how well they work for children and young people with certain solid or brain cancers where previous treatment has not worked or is not available. If you/your child participate in this study, you/they will be asked to join one of the two parts.

Part 1 will help us learn the best dose of the drug to take, and in Part 2 and 3, we will use the information obtained in Part 1 to continue to give the study drug and monitor the side effects.

Inclusion Criteria
  • Patients must have a confirmed diagnosis of a brain tumour or solid tumor with a specific gene change called "ALK fusion"
  • Patients must have a cancer that has come back (relapsed) or has no standard treatment available
  • Patients must be 17 years old or younger to participate 
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours
  • Patients must have a willingness to complete clinical assessments throughout the study (electronic, paper and/or interviewer methods)

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

CDRB436G2201 - Phase II Open-label Global Study to Evaluate the Effect of Dabrafenib in Combination With Trametinib in Children and Adolescent Patients With BRAF V600 Mutation Positive Low Grade Glioma (LGG) or Relapsed or Refractory High Grade Glioma (HGG)

Closed to enrollment

CDRB436G2201 - Phase II Open-label Global Study to Evaluate the Effect of Dabrafenib in Combination With Trametinib in Children and Adolescent Patients With BRAF V600 Mutation Positive Low Grade Glioma (LGG) or Relapsed or Refractory High Grade Glioma (HGG)

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DiagnosisLow Grade Glioma, relapsed or refractory high grade glioma with BRAF V600 mutationStudy StatusClosed to enrollment
PhaseII
AgeChild - (12 Months to 17 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDabrafenib and trametinib (oral). Other drugs are given as usually administered for low grade glioma therapy.
Last Posted Update2022-04-25
ClinicalTrials.gov #NCT02684058
International Sponsor
Novartis Pharmaceuticals
Principal Investigators for Canadian Sites
BC Children’s Hospital – Dr. Juliette Hukin
The Hospital for Sick Children - Dr. Uri Tabori
Montreal Children's Hospital – Dr. Catherine Vézina
CHU Ste-Justine – Dr. Sébastien Perreault


Centres
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

NAIT Program 

nait.info@sickkids.ca

 

Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

(Translated from summary in French available on u-link.eu for the same study)

Gliomas are the most common brain tumors in children. They are classified into two groups: low-grade gliomas common in younger people and high-grade malignant gliomas that affect older children or adolescents. Genetic studies of these tumors have made it possible to highlight specific mutations which open the opportunity to new therapeutic avenues when standard treatments have not been effective.

In this protocol a combination of two drugs is used:

  • Dabrafenib blocks a cellular process necessary for cell proliferation (it is a BRAF inhibitor)
  • Trametinib blocks another process necessary for cell proliferation (it is a MEK inhibitor)

This study explores the efficacy and tolerance of these two new medications taken together.

Their association is studied on the two groups of glioma as follows:

  • For children with high-grade glioma who have not responded to the standard treatment, the two molecules are taken orally every day.
  • For children with low-grade glioma, the children are divided into 2 groups by drawing lots (randomization):
    • The first group receives the two molecules orally every day.
    • The second group receives classical chemotherapy (vincristine and carboplatin) according to standard of care. If the disease progresses despite these treatments, patient will be able to receive the two molecules tested
  • In all cases the tumour will need to have a marker called BRAF V600 for the child to be considered for this study

 

Inclusion Criteria

(Translated from summary in French available on u-link.eu for the same study)

  • Child aged 1 to 18
  • Low or high grade glioma to whom standard treatments have not produced a sufficient response or who have relapsed.
  • In all cases the tumour will need to have a marker called BRAF V600 for the child to be considered for this study
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

AALL15P1 - A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (NSC# 102816) to Chemotherapy in Infants With Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement

Closed to enrollment

AALL15P1 - A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (NSC# 102816) to Chemotherapy in Infants With Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement

Go to Health Care Provider version

DiagnosisALL, Acute Lymphoblastic Leukemia Study StatusClosed to enrollment
PhaseII
AgeChild - up to 364 daysRandomisationN/A
Line of treatmentFirst line treatment
Routes of Treatment AdministrationAzacitidine IV Other drugs are given as usually administered for ALL therapy
Last Posted Update2022-04-25
ClinicalTrials.gov #NCT02828358
International Sponsor
National Cancer Institute (NCI)
Principal Investigators for Canadian Sites
CancerCare Manitoba – Dr. Ashley Chopek
Children's Hospital of Western Ontario – Dr. Shayna Miriam Zelcer
The Hospital for Sick Children – Dr. Ute Bartels
IWK Health Centre – Dr. Craig Erker
Cancer Centre of Southeastern Ontario at Kingston General Hospital – Dr. Mariana Silva
Montreal Children's Hospital - Dr. Sharon Abish
Children’s Hospital of Eastern Ontario (CHEO) – Dr. Donna Johnston
Janeway Hospital – Dr. Lisa Goodyear
Centres
Medical contact
Dr. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
 
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson

 

 

Medical contact
Dr. Craig Erker
Dr. Conrad Fernandez 
Dr. Ketan Kulkarni 
 
Social worker/patient navigator contact
Rhonda Brophy
 
Clinical research contact
Tina Bocking
 
Medical contact
Dr. Laura Wheaton
Dr. Mariana Silva
 
Social worker/patient navigator contact
Jessica Amey
 
Clinical research contact
Heather McLean
 
Medical contact
Dr. Alexandra Zorzi
Dr. Shayna Zelcer
 
Social worker/patient navigator contact
Cindy Milne Wren
Jessica Mackenzie Harris
 
Clinical research contact
Mariam Mikhail
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

NAIT Program 

nait.info@sickkids.ca

 

Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Dr. Donna Johnston
Dr. Lesleigh Abbott
Dr. Doaa Abdel Fattah
 
Social worker/patient navigator contact
Sherley Telisma
 
Clinical research contact
Carol Duchenne
 
Medical contact
Dr. Paul Moorehead
 
Social worker/patient navigator contact
Stephanie Eason
 
Clinical research contact
Bev Mitchell
 

 

 

Study Description

This study is to assess the effectiveness of a chemotherapy called azacitidine in addition to the standard chemotherapy in infants diagnosed with acute lymphoblastic leukemia with a certain mutation called KMT2A-rearrangement.

Enrolled patients will receive four courses of azacitidine during their treatment. The study also looks at the side effects associated with these medications.

Inclusion Criteria
  • Children less than 1 year of age
  • New diagnosis of acute lymphoblastic leukemia
  • Presence of a change called "KMT2A-rearrangement" in the leukemia cells

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

DAY101-001 (FIREFLY-1) - FIREFLY-1: A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients With BRAF-Altered, Recurrent or Progressive Low-Grade Glioma

Open

DAY101-001 (FIREFLY-1) - FIREFLY-1: A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients With BRAF-Altered, Recurrent or Progressive Low-Grade Glioma

Go to Health Care Provider version

DiagnosisLow-grade glioma or solid tumors with RAF alterationsStudy StatusOpen
PhaseII
AgeChild, Adult - (6 Months to 25 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDay101: oral (tablet formulation)
Last Posted Update2022-04-25
ClinicalTrials.gov #NCT04775485
International Sponsor
Day One Biopharmaceuticals, Inc.
Principal Investigators for Canadian Sites
Montreal Children's Hospital – Dr. Nada Jabado
CHU Ste-Justine – Dr. Sebastien Perreault
CHU de Quebec – Dr. Valerie Larouche

Centres
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

 

 

Study Description

The purpose of this study is to see if the experimental drug DAY101 is safe and effective in treating recurrent or progressive (tumor that has come back or isn’t improving despite treatment) glioma or solid tumors in pediatric, adolescent and young adult patients. The drug will be given in the form of oral tablets.

Inclusion Criteria
  • Age between 6 months to 25 years
  • Patient must be diagnosed with low grade glioma or solid tumor, that isn’t improving despite treatment 
  • The tumour must display a genetic change called a "RAF alteration"
  • Patient must be able to swallow oral tablets
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

NMTRC014 - NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

Open

NMTRC014 - NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

Go to Health Care Provider version

DiagnosisNeuroblastomaStudy StatusOpen
PhaseII
AgeChild, Adult - (1 Year to 30 Years )RandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDFMO - oral Other drugs are given as usually administered for neuroblastoma therapy.
Last Posted Update2022-04-25
ClinicalTrials.gov #NCT02679144
International Sponsor
Giselle Sholler
Principal Investigators for Canadian Sites
CHU Ste-Justine - Dr. Pierre Tiera
CHU de Quebec - Dr. Bruno Michon
Montreal Children's Hospital – Dr. Sharon Abish
Alberta Children's Hospital – Dr. Lucie Lafay-Cousin
CancerCare Manitoba – Dr. Ashley Chopek
Janeway Hospital - Dr. Paul Moorehead
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

Medical contact
Dr. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
 
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson

 

 

Medical contact
Dr. Paul Moorehead
 
Social worker/patient navigator contact
Stephanie Eason
 
Clinical research contact
Bev Mitchell
 

 

 

Study Description

This study uses a drug called Difluoromethylornithine (DFMO) for patients with neuroblastoma in remission to assess the effectiveness of preventing recurrence. The study also looks at the side effects associated with these medication. DFMO is a medication taken by mouth. It is an blocker of ornithine decarboxylase, an enzyme involved with polyamine biosynthesis in the cancer cells, including neuroblastoma cells. 

Inclusion Criteria
  • Patients less than 30 years of age, with high-risk neuroblastoma in complete remission. 

2215-CL-0603 (ASP2215) - A Phase 1/2, Multicenter, Open-Label, Single Arm, Dose Escalation and Expansion Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Open

2215-CL-0603 (ASP2215) - A Phase 1/2, Multicenter, Open-Label, Single Arm, Dose Escalation and Expansion Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Go to Health Care Provider version

DiagnosisAcute Myeloid LeukemiaStudy StatusOpen
PhaseI/II
AgeChild, Adult - (6 Months to 21 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationOral for gilteritinib ; other drugs as usually administered for leukemia therapy
Last Posted Update2022-04-25
ClinicalTrials.gov #NCT04240002
International Sponsor
Astellas Pharma Global Development, Inc.
Principal Investigators for Canadian Sites
CHU Ste Justine - Dr. Henrique Bittencourt
Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

This is a study of a new oral medication called gilteritinib, to be given in combination with chemotherapy to patients that have acute myeloid leukemia that has come back (relapse). The leukemia cells need to have a genetic change called "FLT3 ITD" for the patient to be considered for the study. Gilteritinib is an anti-cancer medication that blocks the FLT3 protein when it is abnormal in a leukemia cell.

The main goal of the study will be to establish an optimally safe and biologically active dose of the medication, and then to determine the effect it has on leukemia disease in combination with chemotherapy.

Inclusion Criteria
  • Age from 6 months to 21 years
  • Acute myeloid leukemia that has come back (relapse) and has a genetic change called "FLT3 ITD"
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team