RecruitingPhase 2ACTRN12613000133730

Phase I Study of the Volitinib (HMPL-504) in Patients With Advanced Solid Tumors

A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HMPL-504 in Patients With Advanced Solid Tumors

Sponsor

Hutchison Medipharma Ltd

Enrollment

25 participants

Start Date

Feb 15, 2012

Study Type

Interventional

Conditions

Histologically or cytologically documented, incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior systemic therapy

Summary

A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HMPL-504 in Patients with Advanced Solid Tumors. You may be eligible to join this study if you are aged 18 years or more and have been diagnosed with incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior systemic therapy. Trial details Participants in this trial will be allocated to take Volitinib (HMPL-504) tablets once daily for a period of [a cohort /21 days] at one of six dose levels (100, 200, 400, 600, 800 or 1000 mg/day). Patients will be assigned to dose levels sequentially as they are enrolled. Participants will be assessed for up to 20 months in order to determine safety and tolerability of the treatment. They will also be asked to give blood samples to assess the pharmacokinetics (i.e. action of the drug in the body) over a 21 day period.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is testing a new experimental drug called Volitinib (also known as HMPL-504) in people with advanced solid tumour cancers. The study is in an early phase, which means researchers are mainly checking how safe the drug is and how the body processes it. Participants will take the drug once daily and be closely watched for any side effects. You may be eligible if: - You are 18 years of age or older - You have been diagnosed with a locally advanced or metastatic solid cancer (cancer that has spread) - Your cancer has continued to grow or has not responded to at least one prior treatment - You have a good general health performance status (ECOG 0 or 1) - You are willing to use contraception to prevent pregnancy during the study You may NOT be eligible if: - Your blood, liver, or kidney tests are significantly abnormal - You have an active serious infection - You have side effects from a previous cancer treatment that have not resolved - You are pregnant or breastfeeding - You have had a heart attack - You have active or untreated cancer spread to the brain Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Volitinib(HMPL-504) is a tablet in the form of 25 mg ,100mg and 200mg,oral,once daily. There are six dose cohorts,including 100, 200, 400, 600,800 and 1000 mg/day, HMPL-504 will be administered orall

Volitinib(HMPL-504) is a tablet in the form of 25 mg ,100mg and 200mg,oral,once daily. There are six dose cohorts,including 100, 200, 400, 600,800 and 1000 mg/day, HMPL-504 will be administered orally to patients once daily for each dose cohort.and one cohort contains 21 days.

Locations(1)

WA,VIC, Australia

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ACTRN12613000133730