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Tyrosine Kinase Inhibitor

Fruquintinib (HMPL-013) for Colon Cancer

Phase 1

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 4 weeks or every 8 weeks depending on cohort, through study completion, an average of 6 months

Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective. The drug will be given to patients with advanced solid tumors, metastatic colorectal cancer, and metastatic breast cancer.

Eligible Conditions

Solid Tumors
Colon Cancer
Breast Cancer
Colorectal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 4 weeks or every 8 weeks depending on cohort, through study completion, an average of 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 4 weeks or every 8 weeks depending on cohort, through study completion, an average of 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 4 weeks or every 8 weeks depending on cohort, through study completion, an average of 6 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

Progression free survival (PFS) at 12 weeks

The incidence of DLT in each cohort

Secondary outcome measures

Maximum plasma concentration calculated with blood samples

Objective response rate

Time to reach maximum concentration calculated with blood samples

Trial Design

7Treatment groups

Experimental Treatment

Group I: Metastatic Colorectal Cancer Expansion Cohort CExperimental Treatment1 Intervention

5 mg fruquintinib (HMPL-013) tablet taken daily, 3 weeks on, 1 week off in patients with metastatic colorectal cancer who have not been treated with TAS-102 or regorafenib.

Group II: Metastatic Colorectal Cancer Expansion Cohort BExperimental Treatment1 Intervention

5 mg fruquintinib (HMPL-013) tablet taken daily, 3 weeks on, 1 week off in patients with metastatic colorectal cancer who have progressed on or had intolerable toxicity to TAS-102, regoragenib, or both.

Group III: Metastatic Breast Cancer Expansion Cohort EExperimental Treatment1 Intervention

5 mg fruquintinib (HMPL-013) tablet taken daily, 3 weeks on, 1 week off in patients with metastatic triple negative (Her2-negative, ER-negative, PR-negative) breast cancer.

Group IV: Metastatic Breast Cancer Expansion Cohort DExperimental Treatment1 Intervention

5 mg fruquintinib (HMPL-013) tablet taken daily, 3 weeks on, 1 week off in patients with metastatic Her2-negative, hormone receptor positive breast cancer.

Group V: Fruquintinib Expansion Cohort AExperimental Treatment1 Intervention

5 mg fruquintinib (HMPL-013) tablet taken daily, 3 weeks on, 1 week off in patients with advanced solid tumors.

Group VI: 5 mg Dose EscalationExperimental Treatment1 Intervention

5 mg of Fruquintinib (HMPL-013), tablet taken daily, 3 weeks on, 1 week off

Group VII: 3 mg Dose EscalationExperimental Treatment1 Intervention

3 mg of Fruquintinib (HMPL-013), tablet taken daily, 3 weeks on, 1 week off

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Hutchison Medipharma LimitedLead Sponsor

100 Previous Clinical Trials

13,420 Total Patients Enrolled

HutchmedLead Sponsor

27 Previous Clinical Trials

5,217 Total Patients Enrolled

William SchelmanStudy DirectorHUTCHMED International

3 Previous Clinical Trials

105 Total Patients Enrolled

Frequently Asked Questions

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

How many participants are currently undergoing treatment in this clinical trial?

"This particular clinical trial has concluded its patient recruitment phase. Its original posting date was November 10, 2017 and the most recent edit happened on November 17th 2022. For those looking to participate in similar studies, 2981 trials are presently admitting patients with breast cancer while 22 other trials involve Fruquintinib (HMPL-013)."

Answered by AI

Could you provide an overview of the research conducted on Fruquintinib (HMPL-013) thus far?

"HMPL-013, otherwise known as fruquintinib, was first examined in 2017 at Mayo Clinic Rochester. Since then 12 trials have been successfully completed and 22 are currently ongoing; most of these active studies derive from Phoenix, Arizona."

Answered by AI

How many research centers are involved in the execution of this investigation?

"At the moment, 9 medical sites are participating in this research trial. These include Phoenix, San Marcos and Santa Rosa as well as 6 other cities. It is advisable to select a site located nearby in order to reduce any necessary travel expenses if you should join the study."

Answered by AI

Is there any prior research on this topic?

"Currently, there are 22 active clinical trials for Fruquintinib (HMPL-013) across 16 nations and 159 cities. This medication was initially tested during a Phase 1 study that began in 2017, sponsored by Hutchison Medipharma Limited and involving 128 participants. Since then, 12 further studies have been finished."

Answered by AI

Are opportunities for patient participation in this trial currently available?

"No, this research is no longer recruiting patients as the trial was last updated on November 17th 2022. However, if you are still looking to join a study, there are currently 2981 clinical trials actively enrolling those with breast cancer and 22 studies presently searching for participants that might benefit from Fruquintinib (HMPL-013)."

Answered by AI

What have studies revealed about the safety of Fruquintinib (HMPL-013) for human consumption?

"Due to the preliminary nature of this study, our organisation has assigned HMPL-013 a score of 1 for safety. As it is in Phase 1 testing there is scarce data confirming its efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors, Colorectal, and Breast Cancer

2017. "A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors, Colorectal, and Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03251378.