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Medullary Thyroid CancerPhase 3AcceleRET-MTCNCT04760288

A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC).

A Phase 3 study testing Pralsetinib, Cabozantinib and Vandetanib in people with Medullary Thyroid Cancer, run by Hoffmann-La Roche at 1 site in Spain.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Medullary Thyroid Cancer
What is being tested?
Pralsetinib, Cabozantinib and Vandetanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteSpain
Study dates
30 Nov 2023to 12 Apr 2035
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
  • CLN (Calcitonin) and CEA (carcinoembryonic antigen) level doubling time of less than 24 months.
  • Confirmed RET mutation.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

Other trials in Spain

About this study

Official title: A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for Treatment of RET-Mutated Medullary Thyroid Cancer.

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).

Being tested
Pralsetinib, Cabozantinib, Vandetanib
Medical subject headings
Carcinoma, Medullary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PralsetinibDrug

    Participants will receive pralsetinib at a dose of 400 mg, as per the dosing schedule described above.

  • CabozantinibDrug

    Adult participants will receive cabozantinib at a dose of 140 mg, as per the dosing schedule described above.

  • VandetanibDrug

    Adult participants will receive vandetanib at a dose of 300 mg and adolescent participants will receive vandetanib as per the dosing schedule described above.

Study groups in NCT04760288
Study groupRoleWhat they receive
Arm A (Pralsetinib)ExperimentalParticipants will receive pralsetinib at a dose of 400 milligrams (mg) orally once daily (PO QD) in 28-day cycles.
Receives: Drug: Pralsetinib
Arm B (SOC: Cabozantinib/Vandetanib)Active comparatorAdult participants will receive investigator's choice of SOC MKI therapy with either 140 mg cabozantinib PO QD or 300 mg vandetanib PO QD in 28-day cycles. Adolescents participants (≥ 12 and < 18 years of age) will receive vandetanib, PO QD or every other day, in 28-day cycles depending on the body surface area (BSA), at a dose determined according to the dosing nomogram available in the E.U. Vandetanib SmPC.
Receives: Drug: Cabozantinib; Drug: Vandetanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    Defined as the time from randomization date to the first documented PD (Progression of Disease), as assessed by BICR according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) or death due to any cause, whichever occurs first.

    Measured: Up to 5 years

Secondary outcomes (10)

  1. Time-To-Treatment Failure (TTF)

    Defined as the time from randomization date to the discontinuation of study drug during the treatment period due to death, treatment-related adverse event, or PD, as assessed by BICR according to RECIST v1.1, whichever occurs first.

    Measured: Up to 13 years

  2. Objective Response Rate (ORR)

    Defined as the proportion of participants who achieve a CR (Complete Response) or a PR (Partial Response) prior to progressive disease and/or other anti-cancer therapy, as assessed by BICR according to RECIST v1.1.

    Measured: Up to 13 years

  3. Overall Survival (OS)

    Defined as the time from randomization date to death due to any cause.

    Measured: Up to 13 years

  4. Percentage of Participants With Adverse Events (AEs)

    Incidence and severity determined according to the NCI CTCAE v5.0 (National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0) criteria.

    Measured: Up to 13 years

  5. Duration of Response (DOR)

    Defined as the number of weeks from the time criteria are first met for either a CR or a PR, until the date of documented PD, as assessed by BICR according to RECIST v1.1, or death due to any cause, whichever occurs first.

    Measured: Up to 13 years

  6. Disease Control Rate (DCR)

    Defined as the proportion of participants who experience a best response of CR, PR, or stable disease, as assessed by BICR according to RECIST v1.1.

    Measured: Up to 13 years

  7. Clinical Benefit Rate (CBR)

    Defined as the proportion of participants who experience a CR or a PR or a best response of stable disease with a minimum duration of 6 months, as assessed by BICR according to RECIST v1.1.

    Measured: Up to 13 years

  8. Time to Deterioration of Function

    Defined as the time from randomization to the date of a participant's first >= 10-point decrease from baseline score, as assessed through the use of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).

    Measured: Up to 13 years

  9. Quality of Life (QoL)

    Defined as the time from randomization to the date of a participant's first >= 10-point decrease from baseline score, as assessed through the use of the GHS (Global Health Status)/QoL scales.

    Measured: Up to 13 years

  10. Acceptability and Palatability of Pralsetinib Capsules

    Acceptability Survey scores on Day 1 of Cycle 1 and Crossover Cycle 1 (each cycle is 28 days).

    Measured: Up to 13 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2021
  2. Study start30 Nov 2023 (estimated)
  3. Primary completion6 Oct 2027 (estimated)
  4. Study completion12 Apr 2035 (estimated)

Why it stopped: Due to several logistical challenges during start-up which could not be overcome study was withdrawn.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04760288
Sponsor's protocol ID
CO42865
Other IDs
2020-005269-15
Acronym
AcceleRET-MTC
Status last verified
Jan 2024
First submitted
17 Feb 2021
Last updated
5 Jan 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pralsetinib, Cabozantinib and Vandetanib in people with Medullary Thyroid Cancer, run by Hoffmann-La Roche at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04760288.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.

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