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.

89 results found

Title
Status

 

CO40778 (STARTRK-NG) - A Phase 1/2, Open-Label, Dose-Escalation And Expansion Study Of Entrectinib (Rxdx-101) In Pediatrics With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options

Closed to enrollment

CO40778 (STARTRK-NG) - A Phase 1/2, Open-Label, Dose-Escalation And Expansion Study Of Entrectinib (Rxdx-101) In Pediatrics With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options

Go to Health Care Provider version

DiagnosisAll solid and brain tumors with NTRK1/2/3 or ROS1 gene fusionsStudy StatusClosed to enrollment
PhaseI/II
AgeChild, Adult - (up to 18 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationEntrectinib taken by mouth
Last Posted Update2022-08-05
ClinicalTrials.gov #NCT02650401
International Sponsor
Hoffmann-La Roche
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This clinical trial studies the side effects and how well entrectinib (a medication taken by mouth) works in treating patients with solid tumors and brain tumours with a specific gene change called a "NTRK fusion" or a "ROS1 fusion". Entrectinib may stop the growth of cancer cells with NTRK or ROS1 fusions by blocking the TRK or ROS1 enzymes needed for cell growth.

Inclusion Criteria
  • Age up to 18 years
  • Solid tumors and brain tumours with a change in a called a NTRK1/2/3 fusion or a ROS1 fusion
  • Cancer that has come back (relapse) or is not improving despite treatment (progression)
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team
Publications

Doebele RC, Drilon A, Paz-Ares L, Siena S, Shaw AT, Farago AF, Blakely CM, Seto T, Cho BC, Tosi D, Besse B, Chawla SP, Bazhenova L, Krauss JC, Chae YK, Barve M, Garrido-Laguna I, Liu SV, Conkling P, John T, Fakih M, Sigal D, Loong HH, Buchschacher GL Jr, Garrido P, Nieva J, Steuer C, Overbeck TR, Bowles DW, Fox E, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Demetri GD; trial investigators. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):271-282. doi: 10.1016/S1470-2045(19)30691-6. Epub 2019 Dec 11. Erratum in: Lancet Oncol. 2020 Feb;21(2):e70. Lancet Oncol. 2020 Jul;21(7):e341. Lancet Oncol. 2020 Aug;21(8):e372.

BLU-285-3101 - A Phase 1/2, Single-arm Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of Avapritinib in Pediatric Patients With Solid Tumors Dependent on KIT or PDGFRA Signaling

Open

BLU-285-3101 - A Phase 1/2, Single-arm Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of Avapritinib in Pediatric Patients With Solid Tumors Dependent on KIT or PDGFRA Signaling

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DiagnosisSolid Tumor, Relapsed Solid Neoplasm, CNS TumorStudy StatusOpen
PhaseI/II
Age2 Years to 17 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: avapritinib (Route: Oral) Other Name: BLU-285
Last Posted Update2022-07-19
ClinicalTrials.gov #NCT04773782
International Sponsor
Blueprint Medicines Corporation
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This is a phase 1/2 study that studies the drug avapritinib in patients 2-17 years old with solid tumors that have come back (relapsed) or have not responded to previous treatment (refractory). The tumor must have a certain genetic mutation (in KIT, PDGFRA or H3K27M (glioma only)) to qualify you for the study. The study consists of 2 parts; in part 1, more information will be gathered about the drug's safety and how it moves through the body (pharmacokinetics or PK) and in part 2, the effectiveness, safety and PK will continued to be monitored at the recommended dose. 

Inclusion Criteria
  • Patients must be between 2-17 years old
  • Patients must have a diagnosed solid or central nervous system (CNS) tumor that has progressed despite prior standard therapy or no alternative treatment is available 
  • Patients must be able to be up and about at least half of their waking hours (if applicable)
  • Blood work must come back within acceptable ranges within 14 days of the first study dose
  • Patients must not be pregnant on the trial, participants of child bearing potential must agree to use approved contraception methods
  • Patients and/or their families/caregivers must sign a consent form outlining all assessments and requirements

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

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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

New Agent and Innovative Therapies (NAIT) 

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

Go to Health Care Provider version

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

New Agent and Innovative Therapies (NAIT) 

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.

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)

Go to Health Care Provider version

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

New Agent and Innovative Therapies (NAIT) 

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

New Agent and Innovative Therapies (NAIT) 

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.

TINI - Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I

Closed to enrollment

TINI - Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I

Go to Health Care Provider version

DiagnosisALL, Acute Lymphoblastic LeukaemiaStudy StatusClosed to enrollment
PhaseI/II
AgeChild - up to 365 daysRandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationBortezomib: intravenous: Vorinostat: orally; Other drugs are given as usually administered for ALL therapy
Last Posted Update2022-04-19
ClinicalTrials.gov #NCT02553460
International Sponsor
St. Jude Children's Research Hospital
Principal Investigators for Canadian Sites
BC Children's Hospital - Dr. Kirk R. Schultz
Alberta Children's Hospital - Dr. Victor A. Lewis
Hamilton Health Sciences Centre, McMaster University - Dr. Uma Athale
CHU Ste-Justine - Dr. Thai Hoa Tran
CHU de Quebec - Dr. Bruno Michon
Montreal Children's Hospital - Dr. Catherine Vezina
Stollery Children's Hospital - Dr. Sunil Desai
Centres
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai

 

 

Social worker/patient navigator contact
Danielle Sikora
 Michelle Woytiuk 
Jaime Hobbs
Clinical research contact
Amanda Perreault
Medical contact
Dr. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

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

This study is to assess the effectiveness of two drugs (bortezomib and vorinostat) in addition to standard therapy, for the treatment of infants with a new diagnosis of acute lymphoblastic leukemia. 

The study also looks at the side effects associated with these medications.

Bortezomib is a drug called a "proteasome inhibitor" while vorinostat is a drug called an "HDAC inhibitor".

 

Inclusion Criteria
  • Children younger than 365 days of age with a new diagnosis of acute lymphoblastic leukemia
  • They cannot have had prior treatment with other chemotherapies (with exception of a few medications, with limited amount of doses given).
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

NANT 2019-01 - A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 Erbumine as a Single Agent and in Combination in Patients With Relapsed/Refractory Neuroblastoma

Closed to enrollment

NANT 2019-01 - A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 Erbumine as a Single Agent and in Combination in Patients With Relapsed/Refractory Neuroblastoma

Go to Health Care Provider version

DiagnosisNeuroblastomaStudy StatusClosed to enrollment
PhaseI
AgeChild, Adult - (2 Year to 21 Years)RandomisationYES
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationLY3295668/Erbumine taken by mouth (capsules) Topotecan and cyclophosphamide will be given intravenously
Last Posted Update2022-03-01
ClinicalTrials.gov #NCT04106219
International Sponsor
Eli Lilly and Company
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

The reason for this study is to see if the study medication LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma (neuroblastoma that has come back or is not improving despite treatment). LY3295668 erbumine blocks a protein called Aurora kinase A. Aurora kinase A is thought to contribute to the aggressiveness of neuroblastoma cells. 

The medication will be given either alone or in combination with chemotherapy.

Inclusion Criteria
  • Age between 2 and 21 years
  • Neuroblastoma that has come back (relapse) or is not improving despite treatments (refractory)
  • The child must be able to swallow capsules
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team