NCT02601274

Study of Theliatinib (HMPL-309) in Patients With Advanced Solid Tumor

Open-label, Dose Escalation Phase I Study of Theliatinib (HMPL-309,Xiliertinib) in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase I, open-label, multicenter dose-escalation study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of hmpl-309 in patients with advanced solid tumors

Detailed description

There are two stages to this study: a dose-escalation stage and a dose-expansion stage. Dose-escalation stage: hmpl-309 administered orally once every day(QD) to patients with locally advanced or metastatic solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. Dose-expansion stage: hmpl-309 administered orally 300mg once every day(QD) to patients which is only for patients with EGFR positive oesophageal carcinoma.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Theliatinib	Theliatinib is a tablet in the form of 25 mg ,10mg and 100 mg,oral,once daily

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2015-11-10
• Last updated: 2019-02-25

Locations

2 sites across 1 country: China