Condition or disease | Intervention/treatment | Phase |
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Patients With Advanced Stage Solid Tumors | Drug: Hemay102 | Phase 1 |
Dose escalation:
A total of 7 dosage groups were set at this stage, which were 5 mg/m2, 10 mg/m2, 20 mg/m2, 40 mg/m2, 60 mg/m2, 90 mg/m2, and 120 mg/m2, respectively. Accelerated dosage titration was performed in the first 3 dose groups, 1 subject was enrolled in each group; the last 4 dose groups were perfromed into dosage groups by the principle of "3+3" dose increment rule, and the number of subjects enrolled in each group is 3 to 6 cases.
Dose extension:
According to the test results of the dose escalation phase, two extensions of MTD (tentative 60 mg/m2, 90 mg/m2) were selected for the expansion trial. Each dose level was planned to enroll 6 subjects (12 in total), subjects were administered once every 3 weeks (1 treatment cycle every 3 weeks), and received 4 treatment cycles in a row for Hemay102. Safety, tolerability, pharmacokinetic characteristics, and initial anti-tumor efficacy were evaluated.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 39 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Masking Description: | open-label |
Primary Purpose: | Treatment |
Official Title: | A Dose Escalation Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antitumor Efficacy of Hemay102 in Patients With Advanced Solid Tumors |
Actual Study Start Date : | January 3, 2019 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
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Experimental: Hemay102 at the dosage of 5mg/m2
Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 5mg/m2.
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Drug: Hemay102
Hemay102 was administered through i.v. infusion for 4hrs.
|
Experimental: Hemay102 at the dosage of 10mg/m2
Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 10mg/m2.
|
Drug: Hemay102
Hemay102 was administered through i.v. infusion for 4hrs.
|
Experimental: Hemay102 at the dosage of 20mg/m2
Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 20mg/m2.
|
Drug: Hemay102
Hemay102 was administered through i.v. infusion for 4hrs.
|
Experimental: Hemay102 at the dosage of 40mg/m2
Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 40mg/m2.
|
Drug: Hemay102
Hemay102 was administered through i.v. infusion for 4hrs.
|
Experimental: Hemay102 at the dosage of 60mg/m2
Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 60mg/m2.
|
Drug: Hemay102
Hemay102 was administered through i.v. infusion for 4hrs.
|
Experimental: Hemay102 at the dosage of 90mg/m2
Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 90mg/m2.
|
Drug: Hemay102
Hemay102 was administered through i.v. infusion for 4hrs.
|
Experimental: Hemay102 at the dosage of 120mg/m2
Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 120mg/m2.
|
Drug: Hemay102
Hemay102 was administered through i.v. infusion for 4hrs.
|
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yueying Zhen, Ph.D. | 86-22-2492-9366 | zhenyueying@hemay.com.cn |
China | |
Tianjin medical university cancer hoapital | Recruiting |
Tianjin, China | |
Contact: Ti Zhang, Ph.D. 86-22-23340123 ext 3094 zhangti@tjmuch.com |
Principal Investigator: | Ti Zhang, Ph.D. | Tianjing medical university cancer hospital |
Tracking Information | |||||
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First Submitted Date ICMJE | June 9, 2019 | ||||
First Posted Date ICMJE | June 11, 2019 | ||||
Last Update Posted Date | July 2, 2020 | ||||
Actual Study Start Date ICMJE | January 3, 2019 | ||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of participants with adverse events [ Time Frame: from baseline until 4 weeks after the study day ] Number of participants with adverse events
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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 | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Phase I Study of Hemay102 in Patients With Advanced Solid Tumors | ||||
Official Title ICMJE | A Dose Escalation Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antitumor Efficacy of Hemay102 in Patients With Advanced Solid Tumors | ||||
Brief Summary | This trial was a single-center, open-label, dose-increasing Phase I clinical study with subjects enrolled in patients with advanced solid tumors who failed standard treatment or who were unable to receive effective treatment. The trial is divided into two stages: dose escalation and dose extension. | ||||
Detailed Description |
Dose escalation: A total of 7 dosage groups were set at this stage, which were 5 mg/m2, 10 mg/m2, 20 mg/m2, 40 mg/m2, 60 mg/m2, 90 mg/m2, and 120 mg/m2, respectively. Accelerated dosage titration was performed in the first 3 dose groups, 1 subject was enrolled in each group; the last 4 dose groups were perfromed into dosage groups by the principle of "3+3" dose increment rule, and the number of subjects enrolled in each group is 3 to 6 cases. Dose extension: According to the test results of the dose escalation phase, two extensions of MTD (tentative 60 mg/m2, 90 mg/m2) were selected for the expansion trial. Each dose level was planned to enroll 6 subjects (12 in total), subjects were administered once every 3 weeks (1 treatment cycle every 3 weeks), and received 4 treatment cycles in a row for Hemay102. Safety, tolerability, pharmacokinetic characteristics, and initial anti-tumor efficacy were evaluated. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Masking Description: open-label Primary Purpose: Treatment
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Condition ICMJE | Patients With Advanced Stage Solid Tumors | ||||
Intervention ICMJE | Drug: Hemay102
Hemay102 was administered through i.v. infusion for 4hrs.
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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 | Recruiting | ||||
Estimated Enrollment ICMJE |
39 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2021 | ||||
Estimated Primary Completion Date | December 31, 2021 (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 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03982303 | ||||
Other Study ID Numbers ICMJE | HM102ST1S01 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Tianjin Hemay Oncology Pharmaceutical Co., Ltd | ||||
Study Sponsor ICMJE | Tianjin Hemay Oncology Pharmaceutical Co., Ltd | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Tianjin Hemay Oncology Pharmaceutical Co., Ltd | ||||
Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |