Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of Simotinib Hydrochloride in Patients With Advanced NSCLC
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ClinicalTrials.gov Identifier: NCT01772732 |
Recruitment Status : Unknown
Verified April 2015 by Jiangsu Simcere Pharmaceutical Co., Ltd..
Recruitment status was: Recruiting
First Posted : January 21, 2013
Last Update Posted : April 9, 2015
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Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.
Tracking Information | ||||
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First Submitted Date ICMJE | January 15, 2013 | |||
First Posted Date ICMJE | January 21, 2013 | |||
Last Update Posted Date | April 9, 2015 | |||
Study Start Date ICMJE | December 2012 | |||
Estimated Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Maximum tolerated dose (MTD) [ Time Frame: 28 days ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of Simotinib Hydrochloride in Patients With Advanced NSCLC | |||
Official Title ICMJE | Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of Simotinib Hydrochloride in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) | |||
Brief Summary | The primary objective is to assess the safety and tolerability of multiple doses of Simotinib Hydrochloride in NSCLC patients. The secondary objective is to determine the pharmacokinetic (PK) profile and explore the preliminary anti-tumor activity. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non-small Cell Lung Cancer | |||
Intervention ICMJE | Drug: Simotinib Hydrochloride | |||
Study Arms ICMJE | Experimental: Simotinib Treatment
"3+3" design, ascending multiple doses. Simotinib Hydrochloride: 100mg, 200mg, 300mg, 400mg, 500mg, bid, for 28 days
Intervention: Drug: Simotinib Hydrochloride
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Publications * | Hu XS, Han XH, Yang S, Li N, Wang L, Song YY, Mu H, Shi YK. Safety, tolerability, and pharmacokinetics of simotinib, a novel specific EGFR tyrosine kinase inhibitor, in patients with advanced non-small cell lung cancer: results of a phase Ib trial. Cancer Manag Res. 2019 May 13;11:4449-4459. doi: 10.2147/CMAR.S189626. eCollection 2019. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
30 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | December 2015 | |||
Estimated Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01772732 | |||
Other Study ID Numbers ICMJE | SIM-101-1 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Jiangsu Simcere Pharmaceutical Co., Ltd. | |||
Study Sponsor ICMJE | Jiangsu Simcere Pharmaceutical Co., Ltd. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Jiangsu Simcere Pharmaceutical Co., Ltd. | |||
Verification Date | April 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |