Status:
UNKNOWN
A Phase I Trial of Simmitinib in Advanced Solid Tumors
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Collaborating Sponsors:
Shanghai Runshi Pharmaceutical Technology Co., Ltd
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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 sq...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04058587
Start Date
June 8 2020
End Date
March 31 2023
Last Update
June 6 2022
Active Locations (1)
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1
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Beijing, China