Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors
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ClinicalTrials.gov Identifier: NCT02500199 |
Recruitment Status : Unknown
Verified January 2021 by Hengrui Therapeutics, Inc..
Recruitment status was: Active, not recruiting
First Posted : July 16, 2015
Last Update Posted : February 1, 2021
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Tracking Information | ||||
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First Submitted Date ICMJE | July 2, 2015 | |||
First Posted Date ICMJE | July 16, 2015 | |||
Last Update Posted Date | February 1, 2021 | |||
Study Start Date ICMJE | June 2015 | |||
Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors | |||
Official Title ICMJE | A Two-part Phase I, Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Pyrotinib in Patients With HER2-positive Solid Tumors Whose Disease Progressed on Prior HER2 Targeted Therapy | |||
Brief Summary | Part 1: to assess the safety and tolerability of pyrotinib and to define the maximum tolerated dose (MTD) of pyrotinib in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors (metastatic breast cancer, gastric cancer, or other solid tumors that have no targeted agent as standard of care). Part 2: to estimate the overall response rate (ORR) for patients with HER2-positive metastatic breast cancer (mBC) and HER2 mutant non-small cell lung cancer (NSCLC) treated at the RP2D (or MTD). |
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Detailed Description | This is an open-label, dose escalation study of repeated doses of pyrotinib in patients with HER2-positive advanced solid tumors, including breast cancer, non small cell lung cancer. Part 1 of the trial is dose escalation and is designed to enroll 3 to 6 patients in each dose group. Adverse events (AEs) will be assessed and monitored throughout the study. Dose-limiting toxicities (DLT) will be assessed from the first dose of study drug through day 28 in the first cycle of treatment. Part 2 of the trial will consist of two independent arms: arm A for HER2 positive mBC and arm B for NSCLC with documented HER2 mutation will be investigated to further evaluate safety and the preliminary effectiveness and clinical benefits of pyrotinib as a single agent. |
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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 |
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Intervention ICMJE | Drug: Pyrotinib
Pyrotinib maleate, is provided as yellow, film-coated, immediate release tablets containing pyrotinib maleate at dosage strengths of 80 and 160 mg. Multiple tablets of pyrotinib will be administered daily to achieve targeted doses of pyrotinib: 320 mg, 400 mg, 480 mg, 560 mg and 640 mg. Tablets will be orally administered with water, once daily, 30 min after a meal.
Other Name: SHR1258
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Study Arms ICMJE | Experimental: Pyrotinib
A two-part Phase I, open-label, dose escalation study to evaluate the safety, tolerability and pharmacokinetics of pyrotinib in patients with HER2-positive solid tumors whose disease progressed on prior HER2 targeted therapy
Intervention: Drug: Pyrotinib
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Publications * | Not Provided | |||
* 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 |
50 | |||
Original Estimated Enrollment ICMJE |
40 | |||
Estimated Study Completion Date ICMJE | June 2021 | |||
Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | The study is open to all males and females who meet the following inclusion criteria at screening and baseline to participate in the study. To be included to participate in this study each patient must:
Main Exclusion Criteria: Patients who meet any of the criteria listed below will not be eligible for participation in this study. A patient will not be eligible for study participation if:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02500199 | |||
Other Study ID Numbers ICMJE | SHRUS 1001 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Hengrui Therapeutics, Inc. | |||
Original Responsible Party | Jiangsu HengRui Medicine Co., Ltd. | |||
Current Study Sponsor ICMJE | Hengrui Therapeutics, Inc. | |||
Original Study Sponsor ICMJE | Jiangsu HengRui Medicine Co., Ltd. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Hengrui Therapeutics, Inc. | |||
Verification Date | January 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |