Extensive-Stage Small Cell Lung Cancer
Conditions
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).
Interventions
DRUGSYHA1807
Escalation Cohort Administration: Orally
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug | Through study completion, an average of 2 year | 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. |
| Part 1:Number of Participants With Adverse Events | Through study completion, an average of 2 year | 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) | Through study completion, an average of 2 year | 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) | Through study completion, an average of 2 year | An event was considered a DLT if it occurs within the first 28 days of treatment. |
| Number of Participants With Dose Reduction or Delays | Through study completion, an average of 2 year | 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 | Through study completion, an average of 2 year | 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 | Through study completion, an average of 2 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of SYHA1807 | Through study completion, an average of 2 year | 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. |
| Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of SYHA1807 | Through study completion, an average of 2 year | 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 | Through study completion, an average of 2 year | 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 | Through study completion, an average of 2 year | 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. |
| Apparent Terminal Phase Elimination Rate Constant (λz) Following Single and Repeat Dose Administration of SYHA1807 | Through study completion, an average of 2 year | 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 | Through study completion, an average of 2 year | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Value of NSE(Neurospecific enolase)、Pro-GRP(pro-gastrin releasing peptide)、CT (calcitonin) With Change From Baseline | Through study completion, an average of 2 year | Analysis of the relationship between NSE(Neurospecific enolase)、Pro-GRP(pro-gastrin releasing peptide)、CT (calcitonin) NSE and anti-tumor activity. |
Contacts
Primary ContactKun Lou
Backup ContactXuefang Xia
Outcome results
None listed