Description:
This is an open label, multi-center, phase I study of oral Simmitinib in subjects with
advanced solid tumors including gastric cancer.
Title
- Brief Title: A Phase I Trial of Simmitinib in Advanced Solid Tumors
- Official Title: Phase I Dose-escalation Trial of Simmitinib for Patients With Advanced Solid Tumors in Therapeutic Failure
Clinical Trial IDs
- ORG STUDY ID:
SOMCL-15-290-201901
- NCT ID:
NCT04058587
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Simmitinib | SOMCL-15-290 | Simmitinib tablet |
Purpose
This is an open label, multi-center, phase I study of oral Simmitinib in subjects with
advanced solid tumors including gastric cancer.
Detailed Description
This is an open label, multi-center, phase I study of oral Simmitinib in subjects with
advanced solid tumors including gastric cancer [including gastroesophageal cancer],
cholangiocarcinoma, lung squamous cell carcinoma, urothelial transitional cell carcinoma, and
estrogen-receptor-positive breast cancer patients [ER+], etc. This phase I study will
evaluate the safety, tolerability, pharmacokinetics and the preliminary efficacy of the
FGFR/KDR/CSF1R multi-target inhibitor Simmitinib.
Trial Arms
Name | Type | Description | Interventions |
---|
Simmitinib tablet | Experimental | The core trial period includes 4-weeks Screening stage (28d), 7-days single administration stage, 4-weeks multiple administration stage (28d), 3-days blood collection stage of PK after multiple administration.
The starting dose was set at 1mg/d on toxicology data. Dosing will continue uninterrupted for 28 days in multiple administration stage.
The dose-limiting toxicity (DLT) period assessment will be from the first administration of Simmitinib tablet to the end of the first cycle (35 days). | |
Eligibility Criteria
Inclusion Criteria:
- Voluntary written informed consent of the patient obtained before any study-specific
procedure;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
- Patients with histologically/cytologically confirmed diagnosis of advanced solid
tumors refractory to standard therapy or for whom no standard therapy exist;
- Adequate washing period from last anti-tumor therapy;
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST),
version 1.1;
- The expected survival time for more than 12 weeks;
- Adequate bone marrow, hepatic, renal, pancreas, and coagulation function, Blood
phosphorus and calcium in the normal range.
Exclusion Criteria:
- Prior treatment with selective FGFR inhibitors or multi-target kinase Inhibitors with
FGFR as the main target;
- Unrecovered from any drug-related adverse event to grade ≤ 1 according to the National
Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.3.0
derived from any previous anti-tumor treatment, excluding alopecia, Pigmentation, or
other toxicity with little safety risk for subjects;
- Active Central Nervous System (CNS) metastases (brain or leptomeningeal metastases,
etc.);
- Any other history of malignancy within 3 years;
- Congenital coagulation abnormalities. Active bleeding or previous history of massive
bleeding (>30ml within 3 months), history of hemoptysis (more than 5ml fresh bleeding
within 4 weeks);
- Corneal diseases of clinical significance. There is a history of retinal pigment
epithelial detachment or evidence of the presence of retinal pigment epithelial
detachment. History of age-related macular degeneration or evidence of age-related
macular degeneration exists;
- Subjects with impaired cardiac function or heart disease of clinical significance;
- Pregnant or lactating women.
Maximum Eligible Age: | 70 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Dose-limited toxicity (DLT) |
Time Frame: | 1 year |
Safety Issue: | |
Description: | To identify the dose-limited toxicity (DLT). |
Secondary Outcome Measures
Measure: | Area under the plasma concentration versus time curve (AUC) |
Time Frame: | 2 year |
Safety Issue: | |
Description: | To preliminarily evaluate the AUC in patients with advanced solid tumors. |
Measure: | Peak Plasma Concentration (Cmax) |
Time Frame: | 2 year |
Safety Issue: | |
Description: | To preliminarily evaluate Cmax in patients with advanced solid tumors. |
Measure: | Time of peak plasma concentration (Tmax) |
Time Frame: | 2 year |
Safety Issue: | |
Description: | To preliminarily evaluate Tmax in patients with advanced solid tumors. |
Measure: | Overall response rate (ORR) |
Time Frame: | 2 year |
Safety Issue: | |
Description: | To preliminarily evaluate ORR in patients with advanced solid tumors. |
Measure: | Duration of Response (DoR) |
Time Frame: | 2 year |
Safety Issue: | |
Description: | To preliminarily evaluate DoR in patients with advanced solid tumors. |
Measure: | Median progression free survival (PFS) |
Time Frame: | 2 year |
Safety Issue: | |
Description: | To preliminarily evaluate PFS in patients with advanced solid tumors. |
Measure: | Median overall survival (OS) |
Time Frame: | 2 year |
Safety Issue: | |
Description: | To preliminarily evaluate OS in patients with advanced solid tumors. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. |
Last Updated
August 16, 2019