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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04760288
Registration number
NCT04760288
Ethics application status
Date submitted
17/02/2021
Date registered
18/02/2021
Date last updated
26/10/2023
Titles & IDs
Public title
A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC).
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Scientific title
A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for Treatment of RET-Mutated Medullary Thyroid Cancer.
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Secondary ID [1]
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2020-005269-15
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Secondary ID [2]
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CO42865
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Universal Trial Number (UTN)
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Trial acronym
AcceleRET-MTC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Medullary Thyroid Cancer
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Condition category
Condition code
Cancer
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Thyroid
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Cancer
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Neuroendocrine tumour (NET)
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Metabolic and Endocrine
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Other endocrine disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pralsetinib
Treatment: Drugs - Cabozantinib
Treatment: Drugs - Vandetanib
Experimental: Arm A (Pralsetinib) - Participants will receive pralsetinib at a dose of 400 milligrams (mg) orally once daily (PO QD) in 28-day cycles.
Active Comparator: Arm B (SOC: Cabozantinib/Vandetanib) - Adult 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.
Treatment: Drugs: Pralsetinib
Participants will receive pralsetinib at a dose of 400 mg, as per the dosing schedule described above.
Treatment: Drugs: Cabozantinib
Adult participants will receive cabozantinib at a dose of 140 mg, as per the dosing schedule described above.
Treatment: Drugs: Vandetanib
Adult participants will receive vandetanib at a dose of 300 mg and adolescent participants will receive vandetanib as per the dosing schedule described above.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 5 years
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Secondary outcome [1]
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Time-To-Treatment Failure (TTF)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 13 years
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Secondary outcome [2]
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Objective Response Rate (ORR)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 13 years
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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Defined as the time from randomization date to death due to any cause.
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Timepoint [3]
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Up to 13 years
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Secondary outcome [4]
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Percentage of Participants With Adverse Events (AEs)
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Assessment method [4]
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Incidence and severity determined according to the NCI CTCAE v5.0 (National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0) criteria.
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Timepoint [4]
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Up to 13 years
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Secondary outcome [5]
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Duration of Response (DOR)
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Assessment method [5]
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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.
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Timepoint [5]
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Up to 13 years
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Secondary outcome [6]
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Disease Control Rate (DCR)
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Assessment method [6]
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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.
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Timepoint [6]
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Up to 13 years
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Secondary outcome [7]
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Clinical Benefit Rate (CBR)
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Assessment method [7]
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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.
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Timepoint [7]
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Up to 13 years
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Secondary outcome [8]
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Time to Deterioration of Function
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Assessment method [8]
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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).
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Timepoint [8]
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Up to 13 years
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Secondary outcome [9]
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Quality of Life (QoL)
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Assessment method [9]
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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.
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Timepoint [9]
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Up to 13 years
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Secondary outcome [10]
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Acceptability and Palatability of Pralsetinib Capsules
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Assessment method [10]
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Acceptability Survey scores on Day 1 of Cycle 1 and Crossover Cycle 1 (each cycle is 28 days).
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Timepoint [10]
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Up to 13 years
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Eligibility
Key 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:
1. 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.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
30/10/2023
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
12/04/2035
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Actual
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Sample size
Target
198
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Spain
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State/province [1]
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Cordoba
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Country [2]
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Spain
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State/province [2]
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Sevilla
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04760288
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Reference Study ID Number: CO42865 https://forpatients.roche.com/
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Address
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Country
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Phone
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888-662-6728 (U.S. and Canada)
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04760288
Download to PDF