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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000133730

Acronym

HMPL-504

Enrollment

Registered

2013-02-04

Start date

2012-02-15

Completion date

2013-06-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 orally to patients once daily for each dose cohort.and one cohort contains 21 days.

Study design

Allocation

Non-randomised trial

Intervention model

Other

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Signed Informed Consent Form ,locally advanced, or metastatic solid malignancy ;Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1;Male or female patients of child-producing potential must agree to take contraception measures to avoidance of pregnancy during the study and for 90 days after the last day of treatment; Patients with gastric cancer , NSCLC, colorectal cancer, breast cancer and hepatocellular carcinoma(HCC) are preferred to be enrolled into the study.

Exclusion criteria

Inadequate hematologic and organ function, defined by the following ; Clinical significant active infection; Adverse events from prior anti-cancer therapy that have not resolved to Grade = 1, except for alopecia; Pregnant or lactating women; History of myocardial infarction ; Active or untreated brain metastasis;

Outcome results