Canadian clinical trial registry

Search results

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.

94 results found

Title
Status

 

DCL-17-001 - An Open-Label, Dose Escalation, Efficacy, and Safety Study of CLR 131 in Children and AYA with Select Solid Tumors, Lymphoma, and Malignant Brain Tumors (CLOVER-2) and Expansion in Children, AYA with Relapsed or Refractory High Grade Glioma

Open

DCL-17-001 - An Open-Label, Dose Escalation, Efficacy, and Safety Study of CLR 131 in Children and AYA with Select Solid Tumors, Lymphoma, and Malignant Brain Tumors (CLOVER-2) and Expansion in Children, AYA with Relapsed or Refractory High Grade Glioma

Go to Health Care Provider version

DiagnosisGlioblastoma, Astrocytoma, Oligodendroglioma, Mixed Glioma, Pleomorphic Xanthoastrocytoma, Ganglioglioma, DIPG, Ependymoma Study StatusOpen
PhaseI/II
AgeChild, Adult - (10 years to 25 years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationCLR 131 administered intravenously, fractionated dose Arm 1: two planned cycles, 20 mCi/m2 on day 1 and day 15 Arm 2: three planned cycles, 10mCi/m2 on day 1 and day 15
Last Posted Update2024-06-03
ClinicalTrials.gov #NCT03478462
International Sponsor
Cellectar Biosciences, Inc.
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 of a medication called CLR131. This medication is a targeted radiopharmaceutical, which means it acts like radiation therapy, but is given intravenously as an infusion. 

CLR 131 is designed to target cells with cancer rather than cells without cancer. The main goal of this study is to determine what is the safe amount of medication to give to children with cancer that has come back or is not responding to treatment.

 

Inclusion Criteria
  • Age between 10 and 25 years
  • High Grade Glioma that has come back (relapse) or not improved despite treatment (progression)
  • Must meet all bloodwork requirements
  • Patient must be up and about at least 60% of their waking hours
  • Patient must be willing to comply with study visit requirements and sign a consent form 

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

JZP712-101 - A Phase 1/2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Recommended Phase 2 Dose (RP2D), and Efficacy of Lurbinectedin Monotherapy in Pediatric Participants With Previously Treated Solid Tumors Followed by Expansion to Assess Efficacy and Safety in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma.

Open

JZP712-101 - A Phase 1/2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Recommended Phase 2 Dose (RP2D), and Efficacy of Lurbinectedin Monotherapy in Pediatric Participants With Previously Treated Solid Tumors Followed by Expansion to Assess Efficacy and Safety in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma.

Go to Health Care Provider version

DiagnosisRelapsed/Refractory Ewing SarcomaStudy StatusOpen
PhaseI/II
Age2 Years to 30 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Lurbinectedin Administered as intravenous (IV) infusion once every 3 weeks (Q3W)
Last Posted Update2024-06-03
ClinicalTrials.gov #NCT05734066
International Sponsor
Jazz Pharmaceuticals
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 study is to test the safety of a drug called lurbinectedin in solid tumours that have come back (relapsed) or not responded to treatment (refractory). It is conducted in 2 parts, Phase 2 will further assess this drug in participants with Ewing sarcoma specifically.

Inclusion Criteria
  • Participant must meet the following age requirements:
    • Phase 1 Part 1: participants must be ≥ 2 to < 18 years of age.
    • Phase 1 Part 2: participants must be ≥ 2 to ≤ 30 years of age.
    • Phase 2: participants must be ≥ 2 to ≤ 30 years of age.
  • Participant has a confirmed solid tumor (For phase 2, Ewing Sarcoma)
  • The participant is up and about for more than half their waking hours
  • Participant meets all lab value requirements during the screening period
  • Participant weighs at least 15kg
  • Must not be pregnant (if applicable), and/or must be on an acceptable birth control method 
  • Must sign informed consent and agree to attending all required study assessments 

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team 

LOGGIC/FIREFLY-2 - LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients With Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy

Open

LOGGIC/FIREFLY-2 - LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients With Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy

Go to Health Care Provider version

DiagnosisLow-grade GliomaStudy StatusOpen
PhaseIII
Ageup to 25 YearsRandomisationYES
Line of treatmentFirst line treatment
Routes of Treatment AdministrationExperimental: Arm #1 - Tovorafenib (DAY101), oral
Last Posted Update2024-05-31
ClinicalTrials.gov #NCT05566795
International Sponsor
Sponsor:
Day One Biopharmaceuticals, Inc.

Collaborator:
SIOPe Brain Tumor Group LOGGIC Consortium
Principal Investigators for Canadian Sites
The Hospital for Sick Children
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 3 study to evaluate how safe and effective a drug called tovorafenib is when compared to standard of care chemotherapy. This study is for patients with low-grade glioma (LGG) who have a genetic mutation called a RAF alteration. 

Inclusion Criteria
  • Patients must be under 25 years of age to participate
  • Must have a diagnosis of a low grade glioma that has RAF alteration 

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team. 

APAL2020D - A Randomized Phase 3 Trial of Fludarabine/Cytarabine/Gemtuzumab Ozogamicin With or Without Venetoclax in Children With Relapsed AML

Open

APAL2020D - A Randomized Phase 3 Trial of Fludarabine/Cytarabine/Gemtuzumab Ozogamicin With or Without Venetoclax in Children With Relapsed AML

Go to Health Care Provider version

DiagnosisAcute Myeloid LeukemiaStudy StatusOpen
PhaseIII
Age29 Days to 21 YearsRandomisationYES
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Fludarabine - Intravenous (IV) infusion Drug: Cytarabine - Intravenous (IV) infusion Drug: Gemtuzumab Ozogamicin - Intravenous (IV) infusion Drug: Azacitidine - Intravenous (IV) infusion or subcutaneous injection Experimental Arm Drug: Venetoclax - Orally via tablet or powder suspension
Last Posted Update2024-05-10
ClinicalTrials.gov #NCT05183035
International Sponsor
LLS PedAL Initiative, LLC
Principal Investigators for Canadian Sites
BC Children's Hospital
CancerCare Manitoba
IWK Health Center
Children's Hospital of Eastern Ontario (CHEO)
SickKids - The Hospital for Sick Children - Dr. Jim Whitlock
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
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

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. Donna Johnston
Dr. Lesleigh Abbott
Dr. Doaa Abdel Fattah
 
Social worker/patient navigator contact
Sherley Telisma
 
Clinical research contact
Carol Duchenne
 

 

 

Study Description

This study evaluates if the addition of a drug called venetoclax to chemotherapy improves survival of relapsed acute myeloid leukemia (AML). This is a trial for children, adolescents and young adults with 2nd relapsed AML or 1st relapsed AML unable to receive additional anthracycline containing chemotherapy.

Inclusion Criteria
  • Participants must be ≥ 29 days of age and ≤ 21 years of age at enrollment.
  • Participants must have previously been enrolled on APAL2020SC prior to starting this study 
  • Participants or their parents/guardians must sign a consent form to be on this study
  • Participants must be children, adolescents, and young adults with relapsed acute myeloid leukemia (AML) with either 2nd relapsed AML or 1st relapsed AML unable to receive additional anthracycline containing chemotherapy. 
  • AML must not have a mutation called FLT3/internal tandem duplication (ITD)
  • Participants must have fully recovered from all prior anti-cancer therapy and must meet the minimum durations from prior anti-cancer directed therapy prior to start of protocol treatment. These timelines will be discussed with you by the study team. 
  • Participants must have an adequate performance status (daily activity level)
  • Adequate organ function of the kidneys, liver and heart

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team




     
  •  

VICTORY (OZM-138) - VICTORY: A Pilot Study to Investigate Safety and Efficacy of Weekly Combination of Intravenous Vinblastine With Oral Type II RAF Inhibitor Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas

Open

VICTORY (OZM-138) - VICTORY: A Pilot Study to Investigate Safety and Efficacy of Weekly Combination of Intravenous Vinblastine With Oral Type II RAF Inhibitor Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas

Go to Health Care Provider version

DiagnosisLow-grade GliomaStudy StatusOpen
PhaseI
Age0 Weeks to 25 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Tovorafenib oral (immediate-release tablets or powder for reconstitution) Drug: Vinblastine IV
Last Posted Update2024-05-10
ClinicalTrials.gov #NCT06381570
International Sponsor
IIT - The Hospital for Sick Children
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Uri Tabori
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

VICTORY is an early phase study for patients under 25 years who have a type of brain tumor called low grade glioma (LGG) that coms back or gets worse (recurrent or progressive). To participate on this study, the LGG must have certain genetic changes called CRAF or BRAF alterations.

The study has two parts:

Phase A: We are figuring out the best dose of a combination of two medicines, vinblastine and tovorafenib. Patients will take these medicines for a certain number of months, then just tovorafenib for a few more months. Their progress will be checked regularly with scans.

Phase B: After we find the right dose in Phase A, we'll test how well the combination of these drugs works. Patients will take these medicines for a certain number of months, then just tovorafenib for a few more months. Their progress will be checked regularly with scans.

Patients will be in the study for about two years unless their tumor gets worse (disease progression), they have bad side effects or they decide to withdrawal from the study.

Inclusion Criteria
  • Patients must be less than or equal to 25 years of age at the time of enrollment
  • Patient and/or their parent/guardian must sign an informed consent form to be enrolled on study
  • Patients must have a diagnosis of low grade glioma (LGG) with a genetic alteration called BRAF or CRAF alteration that has come back (recurrent) or not responded to previous treatment (progressive)
  • Patients must have completed at least 1 other therapy prior to enrollment on this study and recovered from its effects.
  • Patients must have adequate performance status (daily activities which they are able to do) 
  • Must have adequate organ function in bone marrow, kidneys, liver, heart and thyroid
  • Willingness of male and female patients with reproductive potential to use double effective birth control methods, defined as one used by the patient and another by his/her partner, for the duration of treatment and for 180 days following the last dose of study drug. 
  • Ability to swallow tablets or liquid, or gastric access via a nasal or gastric tube.

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.

HeadStart4 (IRB15-00399) - HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Randomization to Either Single Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy With Autologous Hematopoietic Progenitor Cell Rescue

Closed to enrollment

HeadStart4 (IRB15-00399) - HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Randomization to Either Single Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy With Autologous Hematopoietic Progenitor Cell Rescue

Go to Health Care Provider version

DiagnosisMedulloblastoma, Central Nervous System Embryonal Tumors, Pineoblastoma, CNS neuroblastoma, CNS ganglioneuroblastomaStudy StatusClosed to enrollment
PhaseIV
AgeChild - (up to 10 years)RandomisationYES
Line of treatmentFirst line treatment
Routes of Treatment AdministrationIV chemotherapies
Last Posted Update2024-05-02
ClinicalTrials.gov #NCT02875314
International Sponsor
Nationwide Children's Hospital
Principal Investigators for Canadian Sites
BC Children's Hospital – Dr. Sylvia Cheng
Alberta Children's Hospital – Dr. Lucie Lafay-Cousin
The Hospital for Sick Children – Dr. Annie A. Huang
Stollery Children's Hospital – Dr. Bev Wilson
Hamilton Health Sciences Centre, McMaster University – Dr. Adam Fleming

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. 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. 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
 
 

 

 

Study Description

This study looks to assess if additional intensive treatment for patients with medulloblastoma and other embryonal brain tumors improves outcomes without adding significant short or long-term side effects. 

Inclusion Criteria

Patients 10 years of age of less with a diagnosis of medulloblastoma or CNS embryonal tumors of the brain or spinal cord. Any stage of medulloblastoma or CNS embryonal tumor in children less than 6 years old are eligible, whereas only high risk patients from 6-10 years of age are eligible. 

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

I3Y-MC-JPCS - A Phase 1b/2 Study of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination With Temozolomide (Part B) in Pediatric and Young Adult Patients With Relapsed/Refractory Solid Tumors and Abemaciclib in Combination With Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients With Relapsed/Refractory Neuroblastoma (Part C)

Suspended

I3Y-MC-JPCS - A Phase 1b/2 Study of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination With Temozolomide (Part B) in Pediatric and Young Adult Patients With Relapsed/Refractory Solid Tumors and Abemaciclib in Combination With Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients With Relapsed/Refractory Neuroblastoma (Part C)

Go to Health Care Provider version

DiagnosisSolid TumorStudy StatusSuspended
PhaseI/II
Ageup to 21 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationAbemaciclib (Given Orally) in combination with: Irinotecan and Temozolomide (Part A Only) Temozolomide alone (Part B Only) Dinutuximab, GM-CSF, Irinotecan, and Temozolomide (Part C Only)
Last Posted Update2024-05-02
ClinicalTrials.gov #NCT04238819
International Sponsor
Eli Lilly and Company
Principal Investigators for Canadian Sites
Ste Justine - Dr. Pierre Teira
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

The study's purpose is to see if the drug, abemaciclib, is safe and effective when given with other drugs to kill cancer cells. The study is open to children and young adults with solid tumors, including neuroblastoma, that did not respond or grew during other anti-cancer treatment.

Inclusion Criteria
  • Participants must be ≤ 18 years of age (Part A and B only) or < 21 years of age (Part C only)
  • Must have adequate body surface area (BSA)
  • Participants must have a solid tumour (excluding lymphoma) that has come back or progressed on standard therapies
  • PART C ONLY: Participants with neuroblastoma that has come back or progressed on standard therapies
  • Participants must be able to be up and about for at least half of their waking hours
  • Participants of reproductive potential must not be pregnant within 7 days of and during the study
  • Ability to swallow
  • Participants and their families (as applicable) must agree to the study assessments by signing an informed consent form

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team

CONNECT1903 - A Pilot and Surgical Study of Larotrectinib for Treatment of Children with Newly-Diagnosed High-Grade Glioma with NTRK Fusion

Open

CONNECT1903 - A Pilot and Surgical Study of Larotrectinib for Treatment of Children with Newly-Diagnosed High-Grade Glioma with NTRK Fusion

Go to Health Care Provider version

DiagnosisHigh Grade Glioma Study StatusOpen
PhaseII
AgeChild, Adult - (up to 21 Years) RandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationOral
Last Posted Update2024-05-01
ClinicalTrials.gov #NCT04655404
International Sponsor
Nationwide Children's Hospital
Principal Investigators for Canadian Sites
Montreal Children’s Hospital – Dr. Geneviève Legault
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
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 

 

 

Study Description

(As seen on the Australian & New Zealand Childrens Haematology/Oncology Group website - https://anzchog.org/clinic-trails/connect-1903-a-pilot-and-surgical-study-of-larotrectinib-for-treatment-of-children-with-newly-diagnosed-high-grade-glioma-with-ntrk-fusion/ )

Recent research shows that a new oral tablet drug, larotrectinib, has produced promising results by shrinking some solid tumours that have an abnormal or mutated NTRK gene in adults and children.

High grade gliomas (HGG) are fast growing, aggressive brain cancers and if they recur after initial treatment, there are no effective treatment options. This study will investigate if larotrectinib alone as well as Larotrectinib  in combination with chemotherapy or radiotherapy can  be of benefit in children with high grade gliomas with the mutated NTRK gene. This international trial will study how well the drug is tolerated and its effectiveness to shrink these tumours when used alone or when given with standard chemotherapy or after radiation.

Inclusion Criteria

(As seen on the Australian & New Zealand Childrens Haematology/Oncology Group website - https://anzchog.org/clinic-trails/connect-1903-a-pilot-and-surgical-study-of-larotrectinib-for-treatment-of-children-with-newly-diagnosed-high-grade-glioma-with-ntrk-fusion/ )

  • Patient must be 21 years old or younger and newly diagnosed with high grade glioma (HGG)
  • The tumour must have a genetic anomaly called an NTRK fusion for the patient to qualify
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team