| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 |
|---|---|
|
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.
|
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 | |||||
|---|---|---|---|---|---|
| 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 |
|
||||
| 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. |
||||
| 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
|
||||
| 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:
|
||||
| Sex/Gender ICMJE |
|
||||
| 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 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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