Status:
UNKNOWN
An Open Label, Multi-center, Phase I Clinical Study to Evaluate the Safety, Effectiveness and Pharmacokinetic Characteristics of SIM1803-1A in Patients With Locally Advanced/Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion Mutations.
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions:
Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This research study is done to test the safety, effectiveness and pharmacokinetic characteristics of SIM1803-1A in patients with locally advanced/metastatic solid tumors with NTRK, ROS1 or ALK gene fu...
Eligibility Criteria
Inclusion
- Adult patients with a locally advanced or metastatic solid tumor that has progressed or was nonresponsive to available therapies, are unfit for standard chemotherapy or for which no standard or available curative therapy exists；Proof of a malignancy harboring a NTRK、ROS1 or ALK fusion；Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 and a life expectancy of at least 3 month；Adequate hematologic, hepatic, and renal function；Signed informed consent form；
Exclusion
- Any contraindications as listed in the local approved product information；Patients with unstable primary central-nervous-system tumors or metastasis, exceptions possible；Pregnancy or lactation；Clinically significant active cardiovascular disease or history of myocardial infarction；Participation in an investigational program with interventions outside of routine clinical practice；Prior treatment with other kinase inhibitor with tropomyosin receptor kinase inhibition；Active uncontrolled systemic bacterial, viral, or fungal infection；Current treatment with a strong CYP3A4 inhibitor or inducer；
Key Trial Info
Start Date :
December 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2024
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT04671849
Start Date
December 21 2020
End Date
January 30 2024
Last Update
January 13 2021
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, China