NCT03125746

A Study of LXI-15029 in Patients With Advanced Malignant Solid Tumors

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles and the Antitumor Activity of LXI-15029 Alone or in Combination With Exemestane at Single Ascending Dose and Multiple Ascending Doses in Chinese Patients With Advanced Malignant Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

1\. To evaluate the safety and tolerability of LXI-15029 in Chinese patients with advanced malignant solid tumors in monotherapy period, including confirmation of the maximum tolerated dose (MTD) of monotherapy. 2.To evaluate the safety and tolerability of LXI-15029 in Chinese postmenopausal patients with metastatic or locally advanced breast cancer with estrogen receptor (+) and human epidermal growth factor receptor 2 (-) in combined with Exemestane period , including confirmation of the maximum tolerated dose(MTD) of the combined therapy with Exemestane.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	LXI-15029	The investigational product for this study is LXI-15029 capsule, which can be administered orally and the specification included 10 mg and 50 mg. There will be about 6 cohorts during the monotherapy period. LXI-15029 capsules will be administered in a therapeutic cycle of 28 days twice a day orally. The patients will be given LXI-15029 continuously, in a therapeutic cycle of 28 days. Patients will continue therapy with LXI-15029 if good safety and tolerability were assessed by investigators after 1 cycle treatment. The treatment will continue until progression or occurrence of unmanageable toxicity.
DRUG	LXI-15029+Exemestane	The combined drug in the combined therapy period of this study (investigational product) is Exemestane tablet (specification 25 mg). Exemestane should be taken at similar time every day in case of multiple doses (Cycle 1 Day 1 to Cycl 1 Day 28). If one dose was missed (e.g., forgetting, vomiting, etc.), this dose could not be made up and should be administered at next scheduled time point. And the dose of LXI-15029 will be determinated by safety review committee after dose escalation

Timeline

• Start date: 2017-06-12
• Primary completion: 2021-10-28
• Completion: 2021-10-28
• First posted: 2017-04-24
• Last updated: 2021-01-05

Locations

1 site across 1 country: China