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A clinical trial to compare pralsetinib with standard-of-care treatment (cabozantinib or vandetanib) in people with RET-mutated medullary thyroid cancer (RET-MTC)
A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC)
- Cancer
- Thyroid Cancer
- Medullary Thyroid Cancer
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:
Withdrawn
This study runs in
Country
- Spain
Study Identifier:
NCT04760288 2020-005269-15 CO42865
Study Summary
A study to evaluate the efficacy and safety of pralsetinib compared with SOC treatment (cabozantinib or vandetanib) for participants with RET (rearranged during transfection)-mutant MTC who have not previously received a SOC MultiKinase Inhibitor (MKI) therapy. Participants will be randomized in a 1:1 ratio into one of two treatment arms: Arm A (pralsetinib) or Arm B (investigator's choice of either cabozantinib or vandetanib for adults and vandetanib for adolescents). Participants whose disease progresses during SOC treatment will be offered the option to cross over to receive pralsetinib after confirmation of progressive disease by blinded independent central review (BICR).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04760288, CO42865, 2020-005269-15
Study Identifier
All
Gender
≥12 Years
Age
No
Healthy Volunteers
How does the AcceleRET-MTC clinical trial work?
This clinical trial is recruiting people who have a type of disease called medullary thyroid cancer (MTC), a rare type of cancer that affects the thyroid gland near the base of the throat. In order to take part, patients must also have changes in a gene called RET, leading to RET-mutated MTC (RET-MTC).
The purpose of this clinical trial is to compare the effects, good or bad, of pralsetinib against standard-of-care treatment in patients with RET-MTC. If you take part in this clinical trial, you will receive either pralsetinib or the clinical trial doctor’s choice of standard-of-care treatment (cabozantinib or vandetanib).
How do I take part in this clinical trial?
To be able to take part in this clinical trial, you must be at least 18 years old (or at least 12 years old, depending on local rules and guardian consent). You must have been diagnosed with MTC that cannot be removed with surgery and/or has spread to other parts of the body. Your cancer must also have changes in a gene called RET, detected by a genetic test. In the last 14 months, you must have been confirmed as having progressive disease (your disease is getting worse).
You must not have received any previous treatment with a specific kind of anti-cancer drug called a kinase inhibitor, and must not have received any radiation therapy in the 14 days before you start this trial. If you are taking certain other medications or have certain other medical conditions, you may not be able to take part in this trial. If you are pregnant or breastfeeding, or intend to become pregnant soon after taking part in this trial, you will not be able to take part.
If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.
You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.
Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.
While taking part in the clinical trial, both men and women (if you are not currently pregnant but can become pregnant) will need to remain abstinent (refrain from heterosexual intercourse) or use appropriate contraception for safety reasons.
What treatment will I be given if I join this clinical trial?
Everyone who joins this clinical trial will be split into two groups randomly (like flipping a coin) and given either:
- Pralsetinib, as capsules to be swallowed once every day
- OR clinical trial doctor’s choice of cabozantinib (as capsules) or vandetanib (as tablets), to be swallowed once every day
You will have an equal chance of being placed in either group.
How often will I be seen in follow-up appointments and for how long?
You will be given the clinical trial treatment (pralsetinib, cabozantinib or vandetanib) for as long as it can help you. If your cancer gets worse while taking cabozantinib or vandetanib, you may be able to receive pralsetinib if you meet certain criteria.
You are free to stop treatment at any time. While being given treatment, you will have clinic visits every 28 days (one cycle). After Cycle 12 is completed (after roughly one year), you will have clinic visits every 12 weeks (three months) until Cycle 24 (roughly the second year) and every 16 weeks (four months) after that. These visits will include checks to see how you are responding to the treatment and any side effects that you may be having. In some areas and if you agree to it, a nurse may come to your home to conduct these checks instead.
Your clinical trial doctor will see you roughly 30 days after your last treatment dose. After this, you will continue to be seen roughly every three months so that the clinical trial doctor can check how you are and whether you have started any new treatments. These visits (or telephone calls) will continue for as long as you agree.
What happens if I am unable to take part in this clinical trial?
If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.
For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/record/NCT04760288
Trial-identifier: NCT04760288
Study Summary
A study to evaluate the efficacy and safety of pralsetinib compared with SOC treatment (cabozantinib or vandetanib) for participants with RET (rearranged during transfection)-mutant MTC who have not previously received a SOC MultiKinase Inhibitor (MKI) therapy. Participants will be randomized in a 1:1 ratio into one of two treatment arms: Arm A (pralsetinib) or Arm B (investigator's choice of either cabozantinib or vandetanib for adults and vandetanib for adolescents). Participants whose disease progresses during SOC treatment will be offered the option to cross over to receive pralsetinib after confirmation of progressive disease by blinded independent central review (BICR).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04760288, CO42865, 2020-005269-15
Study Identifier
Pralsetinib, Cabozantinib, Vandetanib
Treatments
Medullary Thyroid Cancer
Condition
Official Title
A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for Treatment of RET-Mutated Medullary Thyroid Cancer.
Eligibility Criteria
All
Gender
≥12 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Must have histologically confirmed unresectable locally advanced or metastatic MTC and be a candidate for systemic therapy with SOC MKI.
- Must have received no prior systemic anticancer treatment with MKI therapies for advanced or metastatic MTC.
- Must have radiologically confirmed progressive disease within the last 14 months and at least one of the following:
- A MTC-associated symptom and 2. CLN (Calcitonin) and CEA (carcinoembryonic antigen) level doubling time of less than 24 months.
- Confirmed RET mutation.
- Must be able to swallow an oral medication.
- Must have an ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use appropriate contraception during the treatment period and for the respective period of time after final dose of study drug.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use appropriate contraception during the treatment period and for the respective period of time after final dose of study drug and to refrain from donating sperm.
Exclusion Criteria
- Participants who are pregnant or breastfeeding, or intending to become pregnant during the study within 14 days after the final dose of pralsetinib or within 4 months after the final dose of vandetanib or cabozantinib.
- Have disease that is suitable for surgery or radiotherapy administered with curative intent.
- Have been previously treated with any systemic kinase inhibitor therapy regimens, including a selective RET inhibitor, given for recurrent and/or metastatic disease.
- Have received any radiation therapy within 14 days prior to Day 1 of Cycle 1 and any related toxicity must be resolved to Grade 1 or better.
- Participant's tumor has any additional known primary driver alterations other than RET.
- Have known hypersensitivity to pralsetinib, vandetanib, or cabozantinib, or any of their ingredients.
- Have a history of pneumonitis of non-infectious etiology within the last 12 months.
- Have ongoing treatment with chronic immunosuppressants or systemic steroids >10 mg/day.
- Have any history of hereditary bleeding disorder or any evidence of hematemesis.
- Have had major surgery or invasive dental procedure within 3 weeks prior to Day 1 of Cycle 1.
- Have central nervous system (CNS) metastases that are associated with progressive neurologic symptoms, untreated spinal cord compression or requires increasing doses of corticosteroids to control the CNS disease.
- Have clinically significant, uncontrolled, cardiovascular disease.
- Have required treatment with a prohibited medication or herbal remedy.
- Have received hematopoietic growth factor support or transfusion within 14 days of the first dose of study drug.
- Had a major surgical procedure within 14 days of the first dose of study drug.
- Have a history of another primary malignancy that has been diagnosed or required therapy within the past 2 years before randomisation.
- Have a serious infection requiring intravenous (IV) antibiotics within 7 days prior to initiation of study treatment.
- Have an active, uncontrolled infection (viral, bacterial, or fungal) or is positive for Hepatitis B/C infections (HBV/HCV) or HIV.
- Have received organ or allogenic bone marrow or peripheral blood stem cell transplant.
- Is a female who is unwilling to abstain from sexual intercourse or employ highly effective contraception from the time of informed consent and for at least 4 months after the last dose of study drug.
- Is a male who is unwilling to abstain from sexual intercourse or employ highly effective contraception from the time of informed consent and for at least 120 days after the final dose of study drug.
- Have prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's or Sponsor's opinion, could affect the safety of the patient or impair the assessment of study results.
For the latest version of this information please go to www.forpatients.roche.com