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Tyrosine Kinase Inhibitor

Pralsetinib for Thyroid Cancer (ARROW Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately every 8 weeks or 16 weeks based on the treatment cycle (up to approximately 84 months)

Awards & highlights

ARROW Trial Summary

This trial is testing a new drug, pralsetinib, to see if it is safe and effective in treating medullary thyroid cancer, RET-altered non-small cell lung cancer, and other RET-altered solid tumors.

Who is the study for?

This trial is for adults with advanced thyroid cancer, non-small cell lung cancer (NSCLC), and other solid tumors with specific RET gene changes. Participants must have tried certain standard treatments or be ineligible for them. They should not have resectable disease, must be in good physical condition (ECOG 0-1), and agree to provide tissue samples.Check my eligibility

What is being tested?

The study tests Pralsetinib, an oral medication targeting the RET protein in cancers. It's a Phase 1/2 trial assessing safety, tolerability, how the body processes the drug, its effects on tumors, and initial effectiveness against various advanced cancers with RET alterations.See study design

What are the potential side effects?

While not explicitly listed here, side effects of Pralsetinib may include liver issues (elevated enzymes), low blood counts (platelets/neutrophils), potential heart rhythm problems (QT prolongation), kidney function impairment, high serum phosphorus levels or symptomatic lung conditions.

ARROW Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately every 8 weeks or 16 weeks based on the treatment cycle (up to approximately 84 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately every 8 weeks or 16 weeks based on the treatment cycle (up to approximately 84 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately every 8 weeks or 16 weeks based on the treatment cycle (up to approximately 84 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

(Phase 1) Determination of Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Pralsetinib

(Phase 1) Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

(Phase 2) Number of Participants with AEs and SAEs

+1 more

Secondary outcome measures

(Phase 1) ORR

(Phase 1) RET Gene Status and Correlation Between RET Gene Status and ORR, CBR, DOR, DCR, PFS and Other Antineoplastic Measures

(Phase 2) Assess Intracranial Response Rate and Time to Intracranial Progression in Participants With NSCLC

+12 more

ARROW Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2 Dose ExpansionExperimental Treatment1 Intervention

Oral dose of pralsetinib (BLU-667) as determined during Dose Escalation.

Group II: Phase 1 Dose EscalationExperimental Treatment1 Intervention

Multiple doses of pralsetinib (BLU-667) for oral administration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

pralsetinib (BLU-667)

2017

Completed Phase 2

~590

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,428 Previous Clinical Trials

1,088,465 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

887,913 Total Patients Enrolled

Media Library

pralsetinib (BLU-667) (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03037385 — Phase 1 & 2

Lung Disease Research Study Groups: Phase 1 Dose Escalation, Phase 2 Dose Expansion

Lung Disease Clinical Trial 2023: pralsetinib (BLU-667) Highlights & Side Effects. Trial Name: NCT03037385 — Phase 1 & 2

pralsetinib (BLU-667) (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03037385 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other experiments have been undertaken to explore the efficacy of pralsetinib (BLU-667)?

"Currently, a total of 7 studies for pralsetinib (BLU-667) are in progress, 3 of which have reached Phase 3. 677 medical facilities across Cordoba and Calabria are conducting trials to assess the efficacy of this intervention."

Answered by AI

What is the estimated number of participants in this clinical trial?

"Unfortunately, this trial is not currently accepting new participants. Initially posted on March 17th 2017 and last updated November 10th 2022, it has since been concluded. However, there are 8906 medical studies actively recruiting patients with neoplasms by site as well as 7 trials searching for volunteers to test pralsetinib (BLU-667)."

Answered by AI

Has this investigation been conducted before?

"Pralsetinib (BLU-667) is currently in the midst of 7 clinical trials conducted across 175 cities and 45 countries. The drug was initially tested by Hoffmann-La Roche back in 2017, with 589 patients enrolled for their Phase 1 & 2 study. Since then, no further studies have been completed."

Answered by AI

How many healthcare facilities have implemented this research project?

"The current trial is being conducted in 35 medical facilities, including those found in Albany, Jacksonville and Phoenix. To reduce travel-related stressors, participants are urged to select a location nearest them."

Answered by AI

Is the research team at this moment seeking participants for the trial?

"This clinical trial is no longer taking on new participants. It was initially posted in March of 2017 and last updated in November of 2022. If you are still searching for medical studies, there are currently 8906 trials recruiting patients with neoplasms by site and 7 specifically related to pralsetinib (BLU-667)."

Answered by AI

What conditions has pralsetinib (BLU-667) been found to be efficacious for?

"Pralsetinib (BLU-667) is typically prescribed for medullary carcinoma of the thyroid, though it may have some efficacy in treating radioiodine refractory conditions of the adrenal medulla that necessitate systemic treatment."

Answered by AI