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A Phase I Trial of Simmitinib in Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04058587
Recruitment Status : Not yet recruiting
First Posted : August 15, 2019
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
Shanghai Runshi Pharmaceutical Technology Co., Ltd.
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: Simmitinib Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Dose-escalation Trial of Simmitinib for Patients With Advanced Solid Tumors in Therapeutic Failure
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Simmitinib tablet

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).

Drug: Simmitinib

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).

Other Name: SOMCL-15-290




Primary Outcome Measures :
  1. Dose-limited toxicity (DLT) [ Time Frame: 1 year ]
    To identify the dose-limited toxicity (DLT).

  2. Maximum tolerated dose (MTD) [ Time Frame: 1 year ]
    To identify the maximum tolerated dose (MTD).

  3. Recommended Phase II Dose (RP2D) [ Time Frame: 1 year ]
    To identify the Recommended Phase II Dose (RP2D).


Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) [ Time Frame: 2 year ]
    To preliminarily evaluate the AUC in patients with advanced solid tumors.

  2. Peak Plasma Concentration (Cmax) [ Time Frame: 2 year ]
    To preliminarily evaluate Cmax in patients with advanced solid tumors.

  3. Time of peak plasma concentration (Tmax) [ Time Frame: 2 year ]
    To preliminarily evaluate Tmax in patients with advanced solid tumors.

  4. Overall response rate (ORR) [ Time Frame: 2 year ]
    To preliminarily evaluate ORR in patients with advanced solid tumors.

  5. Duration of Response (DoR) [ Time Frame: 2 year ]
    To preliminarily evaluate DoR in patients with advanced solid tumors.

  6. Median progression free survival (PFS) [ Time Frame: 2 year ]
    To preliminarily evaluate PFS in patients with advanced solid tumors.

  7. Median overall survival (OS) [ Time Frame: 2 year ]
    To preliminarily evaluate OS in patients with advanced solid tumors.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT04058587     History of Changes
Other Study ID Numbers: SOMCL-15-290-201901
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms