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Tyrosine Kinase Inhibitor

Pralsetinib for Thyroid Cancer and Non-Small Cell Lung Cancer(ARROW Trial)

Centre Antoine Lacassagne, Nice, France
Targeting 44 different conditionspralsetinib (BLU-667)Phase 1 & 2Waitlist AvailableResearch Sponsored by Hoffmann-La Roche

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.

Eligible Conditions
  • Papillary Thyroid Cancer
  • Lung Disease
  • Head and Neck Cancers
  • Adenocarcinoma
  • Germ Cell Tumors
  • Intestinal Tumors
  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • Intestinal Diseases
  • Endocrine Disorders
  • Medullary Thyroid Cancer
  • Colorectal Cancer
  • Solid Tumors
  • Endocrine Tumors
  • Bronchial Tumors
  • Neuroendocrine Tumors
  • Digestive System Tumors
  • Gastrointestinal Disorders
  • Colonic Diseases
  • Cancer
  • Tumors
  • Gastrointestinal Tumors
  • Neuroendocrine Carcinoma
  • Neoplasms
  • Gastrointestinal Disease
  • Neurofibromatosis
  • Papillary Adenocarcinoma
  • Respiratory Diseases
  • Thyroid Disease
  • Thyroid Neoplasms
  • Neuroectodermal Tumors

ARROW Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Your disease cannot be surgically removed.

ARROW Trial 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)
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,412 Previous Clinical Trials
1,080,358 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,191 Previous Clinical Trials
888,265 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

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

Who else is applying?

What site did they apply to?
Washington University School of Medicine in St. Louis
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~0 spots leftby Dec 2023