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Tyrosine Kinase Inhibitor

Fruquintinib + Tislelizumab for Solid Cancers

Phase 1 & 2
Waitlist Available
Research Sponsored by Hutchison Medipharma Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
Histologically or cytologically documented, advanced or metastatic Triple Negative Breast Cancer, histologically or cytologically documented, advanced or metastatic endometrial carcinoma, histologically or cytologically confirmed advanced or metastatic, unresectable adenocarcinoma of the colon or rectum
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, fruquintinib, to see if it is safe and effective when used with tislelizumab to treat patients with locally advanced or metastatic solid tumors. The trial will be conducted in two parts; a Safety Lead-in Phase (Part 1) and a Dose Expansion Phase (Part 2). Part 1 will be open to any-comer solid tumors and will determine the Recommended Phase 2 Dose (RP2D). The RP2D will be administered to four cohorts of patients in Part 2.

Who is the study for?
This trial is for adults with certain advanced solid tumors, including triple negative breast cancer, endometrial carcinoma, and colorectal cancer. Participants must have a performance status indicating they are relatively active and able to care for themselves. They should not have autoimmune diseases or serious lung conditions, nor should they have received certain prior treatments targeting immune checkpoints or blood vessel growth.Check my eligibility
What is being tested?
The study tests the combination of Fruquintinib, a drug that targets blood vessel growth in tumors, with Tislelizumab, an immunotherapy drug. It's conducted in two parts: first to find the right dose (Safety Lead-in Phase) and then to see how well it works at that dose in different groups of patients (Dose Expansion Phase).See study design
What are the potential side effects?
Potential side effects may include typical reactions from immunotherapies like fatigue, skin reactions or inflammation within organs as well as those related to drugs affecting blood vessels such as high blood pressure or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My cancer is advanced and cannot be surgically removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 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
Adverse Events by type, frequency, and severity
Objective Response Rate
Recommended Phase 2 Dose
Secondary outcome measures
Changes from baseline in biomarkers
Clinical Benefit Rate
Disease Control Rate (DCR)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2Experimental Treatment2 Interventions
Patients will be enrolled to one of the following expansion cohorts: Cohort A: TNBC (immuno-oncology [IO]-treated in the metastatic setting) Cohort B: TNBC (IO-Naïve in the metastatic setting) Cohort C: EC Cohort D: MSS CRC
Group II: Part 1Experimental Treatment2 Interventions
Approximately 6-12 patients with locally advanced or metastatic solid tumors will be enrolled to receive fruquintinib in combination with tislelizumab and assessed for DLTs during the 28-day DLT observation period
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
Not yet FDA approved
Fruquintinib
Not yet FDA approved

Find a Location

Who is running the clinical trial?

BeiGeneIndustry Sponsor
175 Previous Clinical Trials
28,702 Total Patients Enrolled
Hutchison Medipharma LimitedLead Sponsor
100 Previous Clinical Trials
13,437 Total Patients Enrolled
William Schelman, MD, PhDStudy DirectorHutchison MediPharma International
2 Previous Clinical Trials
739 Total Patients Enrolled

Media Library

Fruquintinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04577963 — Phase 1 & 2
Colorectal Cancer Research Study Groups: Part 1, Part 2
Colorectal Cancer Clinical Trial 2023: Fruquintinib Highlights & Side Effects. Trial Name: NCT04577963 — Phase 1 & 2
Fruquintinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04577963 — Phase 1 & 2

Frequently Asked Questions

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

In how many different medical clinics is this medical study being run today?

"Currently, this clinical trial has active enrolment at 18 distinct sites. These locations are situated in Nashville, Houston, Asheville and other surrounding areas. If you choose to enroll in the trial, it would be convenient to select a location nearest to you in order reduce travel time and expenses."

Answered by AI

Are there any unfilled vacancies in this clinical trial?

"Yes, this is accurate. The trial profile on clinicaltrials.gov shows that recruitment is still open for this study. First posted on August 9th, 2021 and most recently updated November 11th, 2022."

Answered by AI

How many human participants are being included in this research?

"That is correct. The information available on clinicaltrials.gov shows that this trial is recruiting patients. This trial was first posted on August 9th, 2021 and the most recent update was November 11th, 2022. A total of 112 patients will be recruited from 18 different sites."

Answered by AI

Is this an unprecedented clinical trial?

"Fruquintinib has been studied since 2017. The first clinical trial occurred in 2017 and was sponsored by Hutchison Medipharma Limited. Following the first trial in 2017, which involved 130 patients, Fruquintinib received its Phase 1 drug approval. Today there are 128 live trials for Fruquintinib across 529 cities and 46 countries."

Answered by AI

Are there other instances where Fruquintinib has been trialed?

"Fruquintinib was first studied in 2017 at Mayo Clinic Rochester. So far, there have been a total of 25 completed studies. Out of the 128 trials that are currently recruiting patients, many are based out of Nashville, Tennessee."

Answered by AI

What are researchers looking to achieve with this clinical trial?

"The primary objective of this study, as measured over an 18-month interval, is to assess the incidence of adverse events by type, frequency, and severity. Additionally, the study will evaluate secondary outcomes including clinical benefit rate (defined as the incidence of partial response and stable disease) and changes from baseline in biomarkers."

Answered by AI

Who else is applying?

What site did they apply to?
HOC AON Baton Rouge / Sarah Cannon
Summit Health NJ
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors
2021. "A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04577963.
All > Colorectal Cancer Glendale > Triple Negative Breast Cancer
~7 spots leftby Jul 2024
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