Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Anti-tumor Activity of SYHA1801 Monotherapy in Patients With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT04309968 |
Recruitment Status : Unknown
Verified March 2020 by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Recruitment status was: Recruiting
First Posted : March 17, 2020
Last Update Posted : June 9, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | March 10, 2020 | ||||
First Posted Date ICMJE | March 17, 2020 | ||||
Last Update Posted Date | June 9, 2020 | ||||
Actual Study Start Date ICMJE | April 7, 2020 | ||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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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 |
Biomarkers and Beneficiaries [ Time Frame: 2 months ] To evaluate potential pharmacodynamic biomarkers(C-MYC、MYCN、BCL-2、HEXIM1、CCR2、CD180、VEGFA) and to assess potential beneficiaries(such as hematoma tumors and myelofibrosis)
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Original Other Pre-specified Outcome Measures |
Biomarkers and Beneficiaries [ Time Frame: 2 months ] To evaluate potential pharmacodynamic biomarkers and to assess potential beneficiaries
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Descriptive Information | |||||
Brief Title ICMJE | Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Anti-tumor Activity of SYHA1801 Monotherapy in Patients With Advanced Solid Tumors | ||||
Official Title ICMJE | A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Anti-tumor Activity of SYHA1801 Capsules in Patients With Advanced Solid Tumors. | ||||
Brief Summary | This is a safety, pharmacokinetic and pharmacodynamic study designed to estimate the maximum tolerated dose (MTD), and determine the Recommended Phase 2 Dose (RP2D) of SYHA1801, a BRD4 inhibitor in patients with advanced solid tumors. | ||||
Detailed Description | This study will be performed in two parts. Part 1 will enroll patients with advanced solid tumors. Patients will receive SYHA1801 orally on Days 1 and 4-31 in the first cycle. Enrollment will follow a dose-escalation schedule until grade 3 drug-related adverse events are observed, at this point the i3+3 enrollment design will be used. Dose increments will be guided by data generated from previous levels. The dose and possibly the schedule will be adjusted to determine the Maximum Tolerated Dose (MTD). If a patient wishes to continuously receive study treatment on completion of Cycle 1, the patient can continue study treatment in 28-day Cycle 2 and subsequent cycles. Part 2 will enroll patients with specific solid tumor which might potentially respond to BRD4 inhibitor. Patients will receive SYHA1801 at a dose and schedule established in Part 1. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Intervention Model Description: Parallel Assignment Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Advanced Solid Tumors | ||||
Intervention ICMJE | Drug: Drug: SYHA1801
Drug: SYHA1801 administered orally
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Study Arms ICMJE |
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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 |
186 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 30, 2023 | ||||
Estimated Primary Completion Date | December 31, 2022 (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 75 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 | NCT04309968 | ||||
Other Study ID Numbers ICMJE | SYHA1801201901/PRO | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | ||||
Verification Date | March 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |