A Study of LXI-15029 in Patients With Advanced Malignant Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03125746|
Recruitment Status : Unknown
Verified August 2017 by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd..
Recruitment status was: Recruiting
First Posted : April 24, 2017
Last Update Posted : August 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Advanced Breast Cancer||Drug: LXI-15029 Drug: LXI-15029+Exemestane||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||June 12, 2017|
|Estimated Primary Completion Date :||February 28, 2020|
|Estimated Study Completion Date :||February 28, 2020|
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.
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
- Number of participants with adverse events [ Time Frame: When subject complete 1 cycle (28 days) treatment with safety and tolerability assessment by investigators. ]To evaluate the safety and tolerability of LXI-15029 through evaluation of the incidence and severity of adverse event (Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE, 4.03))
- Maximum Concentration (Cmax) [ Time Frame: When subject complete 1 cycle (28 days) treatment ]Characterising the pharmacokinetics (PK) profile of LXI-15029
- Area Under the Curve (AUC) [ Time Frame: When subject complete 1 cycle (28 days) treatment ]Characterising the pharmacokinetics (PK) profile of LXI-15029
- Tmax [ Time Frame: When subject complete 1 cycle (28 days) treatment ]Characterising the pharmacokinetics (PK) profile of LXI-15029
- Best objective response [ Time Frame: Estimated to be up to 6 months ]Best Objective Response per Response Evaluation Criteria in Solid Tumours Criteria (RECIST) 1.1 for target and non target lesions assessed by CT, MRI or X-ray; Complete Response (CR), Disappearance of all target lesions since baseline; Partial Response (PR), At least a 30 percent decrease in the sum of diameters of target lesions; Progressive Disease (PD), At least a 20 percent increase in the sum of diameters of target lesions and an absolute increase of at least 5mm
- Progression-free survival (PFS) [ Time Frame: Estimated to be up to 6 months ]Duration from treatment start to the time of disease progression or death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125746
|Contact: Wenliang Wang, Master||86-21-61060190 ext firstname.lastname@example.org|
|Cancer Hospital Chinese Academy of Medical Sciences||Recruiting|
|Contact: Binghe Xu, Doctor|