Back to resultsA Study of SYHA1807 in Subjects With Extensive-Stage Small Cell Lung Cancer
Primary Purpose
Extensive-Stage Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SYHA1807
SYHA1807
Sponsored by
About this trial
This is an interventional treatment trial for Extensive-Stage Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of advanced SCLC;
- ECOG(Eastern Cooperative Oncology Group) performance status of 0 or 1;
- Measurable disease according to RECIST v1.1;
- Recovered from all toxicities associated with previous treatments;
- Life expectancy ≥ 3 months;
- Adequate organ function;
- Use of reliable contraceptive methods;
- Signed informed consent from the patient;
Exclusion Criteria:
- Patients with primary malignant tumor other than small cell lung cancer;
- Identified central nervous system metastasis (such as brain metastasis or meningeal metastasis);
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- Inadequate washout period for previous anti-tumor therapy;
- Previous treatment with any LSD1(lysine specific demethylase 1) inhibitor;
- Unable to swallow oral medications;
- History of serious systemic diseases;
- History of serious autoimmune diseases；
- HIV positive;
- Pregnant or lactating women.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Escalation Cohort
Dose Expansion Cohort
Arm Description
Five dose levels will be tested according to the "3 + 3" dose-escalation design. The dose-limiting toxicity (DLT) will be assessed from the first administration of SYHA1807 to the end of the first cycle (28 days).
Once the RP2D has been determined, an expansion cohort of up to 12~40 subjects will be enrolled in order to better characterize the clinical activity and safety profile of the RP2D.
Outcomes
Primary Outcome Measures
Part 1:Number of Participants With Adverse Events
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Part 1:Number of Participants With Serious Adverse Events (SAEs)
SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function.
Part 1:Number of Participants With Dose Limiting Toxicities (DLT)
An event was considered a DLT if it occurs within the first 28 days of treatment.
Number of Participants With Dose Reduction or Delays
The number of participants who had any dose reduction or delay have been presented. All dose reductions were due to AEs.
Number of Participants Withdrawn Due to Toxicities
Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to toxicities has been presented.
Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline
Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The number of participants with any grade increase in hematology parameters have been presented.
Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug
Vital sign measurements includes systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature, respiration rate and heart rate. The number of participants with critical changes in values of vital signs in response to drug have been presented.
Secondary Outcome Measures
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of SYHA1807
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.
Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of SYHA1807
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.
Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of SYHA1807
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed. Tmax is the time to reach Cmax, determined directly from the concentration-time data.
Apparent Terminal Phase Elimination Rate Constant (λz) Following Single and Repeat Dose Administration of SYHA1807
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.
Apparent Terminal Phase Half-life (T1/2) Following Single and Repeat Dose Administration of SYH1A1807
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.
Number of Participants Achieving Disease Control Rate at Week 6、12
Clinical response was assessed by the investigator using computer tomography or magnetic resonance imaging scans. Clinical response was defined as disease control rate ,CR(Complete response)+PR(Partial response)+SD(Stable disease),based on RECIST version 1.1 at Week 6、12.
Full Information
NCT ID
NCT04404543
First Posted
May 14, 2020
Last Updated
May 22, 2020
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04404543
Brief Title
A Study of SYHA1807 in Subjects With Extensive-Stage Small Cell Lung Cancer
Official Title
A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics and Clinical Activity of SYHA1807 Given Orally in Subjects With Extensive-Stage Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a phase I, open-label, multi-center, non-randomized, 2-part first time inhuman (FTIH) study for SYHA1807. Part 1 is a dose escalation phase to determine the recommended phase 2 dose (RP2D) for SYHA1807 based on the safety, tolerability and pharmacokinetics (PK) profiles observed after oral administration of SYHA1807. The dose escalation study will be performed according to the 3+3 design. Once RP2D is identified, an expansion cohort (Part 2) of up to 12~40 subjects will be enrolled to further evaluate the clinical activity and tolerability of SYHA1807 in subjects with extensive-stage Small Cell Lung Cancer (SCLC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive-Stage Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Escalation Cohort
Arm Type
Experimental
Arm Description
Five dose levels will be tested according to the "3 + 3" dose-escalation design.
The dose-limiting toxicity (DLT) will be assessed from the first administration of SYHA1807 to the end of the first cycle (28 days).
Arm Title
Dose Expansion Cohort
Arm Type
Experimental
Arm Description
Once the RP2D has been determined, an expansion cohort of up to 12~40 subjects will be enrolled in order to better characterize the clinical activity and safety profile of the RP2D.
Intervention Type
Drug
Intervention Name(s)
SYHA1807
Intervention Description
Escalation Cohort Administration: Orally
Intervention Type
Drug
Intervention Name(s)
SYHA1807
Intervention Description
Dose Expansion Cohort Administration: Orally
Primary Outcome Measure Information:
Title
Part 1:Number of Participants With Adverse Events
Description
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame
Through study completion, an average of 2 year
Title
Part 1:Number of Participants With Serious Adverse Events (SAEs)
Description
SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function.
Time Frame
Through study completion, an average of 2 year
Title
Part 1:Number of Participants With Dose Limiting Toxicities (DLT)
Description
An event was considered a DLT if it occurs within the first 28 days of treatment.
Time Frame
Through study completion, an average of 2 year
Title
Number of Participants With Dose Reduction or Delays
Description
The number of participants who had any dose reduction or delay have been presented. All dose reductions were due to AEs.
Time Frame
Through study completion, an average of 2 year
Title
Number of Participants Withdrawn Due to Toxicities
Description
Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to toxicities has been presented.
Time Frame
Through study completion, an average of 2 year
Title
Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline
Description
Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The number of participants with any grade increase in hematology parameters have been presented.
Time Frame
Through study completion, an average of 2 year
Title
Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug
Description
Vital sign measurements includes systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature, respiration rate and heart rate. The number of participants with critical changes in values of vital signs in response to drug have been presented.
Time Frame
Through study completion, an average of 2 year
Secondary Outcome Measure Information:
Title
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of SYHA1807
Description
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.
Time Frame
Through study completion, an average of 2 year
Title
Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of SYHA1807
Description
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.
Time Frame
Through study completion, an average of 2 year
Title
Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of SYHA1807
Description
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed. Tmax is the time to reach Cmax, determined directly from the concentration-time data.
Time Frame
Through study completion, an average of 2 year
Title
Apparent Terminal Phase Elimination Rate Constant (λz) Following Single and Repeat Dose Administration of SYHA1807
Description
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.
Time Frame
Through study completion, an average of 2 year
Title
Apparent Terminal Phase Half-life (T1/2) Following Single and Repeat Dose Administration of SYH1A1807
Description
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.
Time Frame
Through study completion, an average of 2 year
Title
Number of Participants Achieving Disease Control Rate at Week 6、12
Description
Clinical response was assessed by the investigator using computer tomography or magnetic resonance imaging scans. Clinical response was defined as disease control rate ,CR(Complete response)+PR(Partial response)+SD(Stable disease),based on RECIST version 1.1 at Week 6、12.
Time Frame
Through study completion, an average of 2 year
Other Pre-specified Outcome Measures:
Title
Value of NSE(Neurospecific enolase)、Pro-GRP(pro-gastrin releasing peptide)、CT (calcitonin) With Change From Baseline
Description
Analysis of the relationship between NSE(Neurospecific enolase)、Pro-GRP(pro-gastrin releasing peptide)、CT (calcitonin) NSE and anti-tumor activity.
Time Frame
Through study completion, an average of 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of advanced SCLC;
ECOG(Eastern Cooperative Oncology Group) performance status of 0 or 1;
Measurable disease according to RECIST v1.1;
Recovered from all toxicities associated with previous treatments;
Life expectancy ≥ 3 months;
Adequate organ function;
Use of reliable contraceptive methods;
Signed informed consent from the patient;
Exclusion Criteria:
Patients with primary malignant tumor other than small cell lung cancer;
Identified central nervous system metastasis (such as brain metastasis or meningeal metastasis);
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
Inadequate washout period for previous anti-tumor therapy;
Previous treatment with any LSD1(lysine specific demethylase 1) inhibitor;
Unable to swallow oral medications;
History of serious systemic diseases;
History of serious autoimmune diseases；
HIV positive;
Pregnant or lactating women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kun Lou
Phone
031167808817
Ext
031167808817
Email
loukun@mail.ecspc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xuefang Xia
Phone
031167808812
Ext
031167808812
Email
xiaxuefang@mail.ecspc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun Lou
Organizational Affiliation
Department of Medicine, CSPC Clinical Development Division
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
A Study of SYHA1807 in Subjects With Extensive-Stage Small Cell Lung Cancer
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