Canadian clinical trial registry

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Study Description

This research looks at how well a medicine called nirogacestat works in treating desmoid tumours or aggressive fibromatosis. At first, patients participating in the study are split into two groups randomly: one group gets nirogacestat, and the other group gets a placebo, which is a which is a substance that has no therapeutic effect and is indistinguishable from the actual drug. This part of the study is "double-blind," meaning neither the participants nor the researchers know who's getting the real medicine and who's getting the placebo. Later, when participants move to the next part of the study, called the "open-label phase," everyone gets nirogacestat. 

Inclusion Criteria

• Participants must be 18 years or older
• Must have confirmed Desmoid Tumor or Aggressive Fibromatosis that has progressed or not responded after at least one line of therapy 
• Participants must be up and about at least 50% of their daily waking hours
• Participants must meet organ function and lab criteria prior to starting on study
• Participants must sign an informed consent and agree to the study assessments and requirements

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

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Study Description

This study is trying to find out if adding a new drug (pembrolizumab) to the standard treatment for soft tissue sarcoma, makes the treatment work better. Researchers will compare two groups: one group gets the standard treatment of radiation before surgery, and the other group gets pembrolizumab with radiation before surgery, plus more pembrolizumab after surgery for a year, to see which group does better.

Inclusion Criteria

• Participant must be 12 years of age or older
• Participant must have an applicable sarcoma diagnosis in their extremity (patients with skin cancer, carcinoma or low-risk prostate cancer may also be eligible)
• Participant should be able to be up and about throughout the day with minimal restriction 
• Must meet all lab and organ function requirements within 10 days of starting on study 
• Participant or parent/caregiver must be willing to sign an informed consent and agree to the study requirements 
• If participants are able to have children, they must agree to use an effective method of birth control while on study and for 120 days after the last dose of pembrolizumab. 

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

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Study Description

This study will explore the safety, tolerability and efficacy of the biologic CC-96191 in acute myeloid leukemia (AML) that has come back or not responded to previous treatment. 

Inclusion Criteria

• Patient must be 18 years or older
• Patient must have AML that has come back (relapsed) or not responded to previous treatment
• Patient must be willing to sign a consent form
• Females and males must practice true abstinence or agree to approved contraceptive methods throughout the study, and during the safety follow-up period.

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

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Study Description

This is a Phase 1b/2 study of the drug DAY101 in patients ≥12 years of age with solid tumours or brain tumours that have come back or progressed. This study includes 2 sub-studies, patients in sub-study A will receive the DAY-101 drug and patients in sub-study B will receive "DAY-101" and another drug called pimasertib in combination.

Inclusion Criteria

• Participants must be between 12 to 18 years old
• Participants must have a solid tumour or brain tumour that has come back (relapsed) or progressed 
• Participants must have a qualifying gene change in the tumour (MAPK pathway)
• If enrolled on study, patients and their families must agree to the study requirements by signing an informed consent/assent form

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

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Study Description

This study is aimed at improving the outcome for children with High Grade Glioma (HGG). Temozolomide, a medication taken by mouth, has been shown to improve survival in adults with glioblastoma, when taken during and after radiation. In this study, patients with a HGG that has specific molecular features (wild-type for H3-K27, IDH and BRAF) will receive experimental therapy of veliparib (given by mouth) during radiation therapy, followed by veliparib in combination with temozolomide.

This study will test whether this combination therapy may improve survival in children with newly diagnosed HGG that are wild-type for H3-K27, IDH and BRAF. Patients with IDH mutant glioma are also eligible. The outcomes of patients on this study will be compared to other patients with clinically and molecularly similar HGG treated with temozolomide alone.

(Retrieved from: https://www.childrensoncologygroup.org/acns1721)

Inclusion Criteria

• Patients must be at least 3 years old and less than 22 years of age. Patients less than 25 years old may be eligible to enroll if they have a specific type of high grade glioma
• Patients must have newly diagnosed High Grade Glioma, that does not include brainstem or spinal cord tumors, or disease that has spread to other parts of the body (metastatic disease)
• Patients must agree to the study activities outlined in the consent forms; including MRI's, blood tests, biopsies etc - as they apply
• Patients must be able to walk and do routine activities for more than half of their normal waking hours
• If the patient has a seizure disorder, they may be enrolled if the seizures are well-controlled
• A written consent form must be signed by the patients and/or their parents/legal guardians

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

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Study Description

This study is to assess the effectiveness of molecular targeted therapy (four different possible medications) in addition to standard therapy for patients with a new diagnosis of high-risk neuroblastoma. The study also looks at the side effects associated with these medications.

The study also tests the effects of a drug called DFMO when added to the immunotherapy given as post-consolidation treatment.

Inclusion Criteria

• Age 1 to 22 years
• New diagnosis of high risk neuroblastoma
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This is a Phase 2 trial for newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of combining the drug naxitamab with standard induction therapy. Initially, there will be 5 cycles of standard chemotherapy with Naxitamab on days 1, 3 and 5 of each cycle. Patients with an ALK mutation or amplification will have the drug ceritinib added to their treatment regimen as soon as results are available. 

Inclusion Criteria

• Subjects must have a diagnosis of neuroblastoma or ganglioneuroblastoma that meets criteria
• Subjects must be age ≤ 21 years at initial diagnosis
• Subjects must be >12 months of age at enrollment
• Subject's bloodwork must be within acceptable study ranges
• Pregnant subjects are not eligible for this study, a negative serum pregnancy test is required for female participants of childbearing potential
• Both male and female study subjects who have reached puberty must be willing to use a highly effective contraceptive method, these methods will be discussed with you by the study team
• All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines.
• Subjects enrolled on study must complete all required assessments 

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Study Description

This study seeks to test the effectiveness and best dosage for 2 different combinations of drugs in treating cancers that have come back (recurring) or never completely went away (refractory) after initial treatment. Participants will be randomly assigned to either Arm A or Arm B of the study which will determine the combination of drugs they receive.

In Arm A, participants will receive drugs called Onivyde and talazoparib.

In Arm B, participants will receive drugs called Onivyde and temozolomide.

Both combination of drugs (Onivyde + talazoparib or Onivyde + temozolomide) are expected to irreparably damage the DNA in cancer cells and lead to cancer cell death.

After the best dosages of the drug combinations are determined in Arm A and Arm B, then the study will move on to the next stage called “expansion arms”. These expansion arms treat more participants with the dosages determined in the earlier Arm A and Arm B.

There are 3 expansion arms in this study:

Arm A1: Participants with Ewing sarcoma that has come back (recurring) or never completely went away (refractory) will receive drugs called Onivyde and talazoparib.

Arm A2: Participants with cancers that have come back (recurring) or never completely went away (refractory), and their cancer has a problem with repairing DNA (identified by their doctor) will receive drugs called Onivyde and talozoparib.

Arm B1: Participants with cancers that have come back (recurring) or never completely went away (refractory) will receive drugs called Onivyde and temozolomide.

Inclusion Criteria

• Participants must be > 12 months and <30 years at the time of enrollment
• Diagnosed with cancers that have come back (recurring) or never completely went away (refractory)

• Female or male participant of reproductive potential must agree to use effective contraceptive methods at screening and throughout duration of study treatment.
• Female participants who have begun to menstruate must have a negative urine or serum pregnancy test and must be willing to have additional serum and urine pregnancy tests during the study
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team