Clinical Trials /

A Phase I Trial of Simmitinib in Advanced Solid Tumors

NCT04058587

Description:

This is an open label, multi-center, phase I study of oral Simmitinib in subjects with advanced solid tumors including gastric cancer.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

  • Advanced Solid Tumor

Interventions

DrugSynonymsArms
SimmitinibSOMCL-15-290Simmitinib 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

NameTypeDescriptionInterventions
Simmitinib tabletExperimentalThe 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).
  • Simmitinib

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