What side effects are associated with this type of intervention?

Common treatments for endocrine disorders, particularly those involving RET inhibitors like Pralsetinib (BLU-667), often include targeted therapies such as tyrosine kinase inhibitors. Known side effects of these treatments can include hypertension, diarrhea, fatigue, liver enzyme abnormalities, and hematologic toxicities such as neutropenia and thrombocytopenia. Patients may also experience gastrointestinal symptoms, skin reactions, and, less commonly, more severe adverse events like interstitial lung disease or cardiac issues. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for endocrine disorders, particularly targeting cancers with RET alterations. One notable approval is for the RET inhibitor selpercatinib (Retevmo), which is used for treating RET fusion-positive non-small cell lung cancer, RET-mutant medullary thyroid cancer, and RET fusion-positive thyroid cancer. These approvals are significant as they provide targeted therapy options for patients with specific genetic alterations in their tumors, similar to the investigational drug Pralsetinib (BLU-667).

What other types of research exist?

Selpercatinib is a promising alternative to Pralsetinib for patients with endocrine disorders, particularly those with medullary thyroid cancer. It has shown success in treating ectopic Cushing's syndrome due to medullary thyroid cancer, especially when other treatments are ineffective or not tolerated.

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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 12 months)

Awards & highlights

Summary

This trial is testing a new oral drug called pralsetinib in patients with advanced cancers that have specific genetic changes and have not responded to other treatments. The drug aims to stop cancer growth by blocking a faulty gene. Pralsetinib is designed to target specific genetic alterations in various cancers.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately every 8 weeks or 16 weeks based on the treatment cycle (up to approximately 12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately every 8 weeks or 16 weeks based on the treatment cycle (up to approximately 12 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 12 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

(Phase 2) Overall Response Rate (ORR)

Secondary study objectives

(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

+4 more

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for endocrine disorders include hormone replacement therapies, medications that modulate hormone production, and targeted therapies like RET inhibitors. Hormone replacement therapies, such as levothyroxine for hypothyroidism, work by supplementing deficient hormones. Medications like methimazole for hyperthyroidism reduce excessive hormone production. RET inhibitors, such as Pralsetinib (BLU-667), target specific genetic mutations in cancer cells, inhibiting tumor growth and progression. Understanding these mechanisms is crucial for patients as it helps tailor treatments to their specific conditions, improving efficacy and minimizing side effects.

Co-targeting CDK4/6 and AKT with endocrine therapy prevents progression in CDK4/6 inhibitor and endocrine therapy-resistant breast cancer.Overall survival (OS) endpoint: an incomplete evaluation of metastatic breast cancer (MBC) treatment outcome.Repositioning therapy for thyroid cancer: new insights on established medications.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,444 Previous Clinical Trials

1,092,533 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,212 Previous Clinical Trials

891,827 Total Patients Enrolled

Media Library

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

Papillary Thyroid Cancer Research Study Groups: Phase 1 Dose Escalation, Phase 2 Dose Expansion

Papillary Thyroid Cancer 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

~69 spots leftby Sep 2025

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