NCT02004548
Completed
Phase 1
A Phase I, Multiple Dose Escalation Clinical Trial of Metatinib Tromethamine Tablet in Patients With Advanced or Metastatic Solid Tumors
Jiangsu Simcere Pharmaceutical Co., Ltd.1 site in 1 country18 target enrollmentStarted: May 2013Last updated:
ConditionsAdvanced or Metastatic Solid Tumors
InterventionsMetatinib Tromethamine
Overview
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Dose-limiting Toxicity (DLT)
Overview
Brief Summary
Primary Objective: To evaluate the safety, tolerability and maximum tolerated dose (MTD) of daily oral administration of metatinib tromethamine in subjects with solid tumors; Investigate the influence of food on pharmacokinetic parameters.
Secondary Objective: To evaluate the plasma pharmacokinetics (PK) of daily oral administration of metatinib tromethamine in subjects with solid tumors; To observe preliminary anti-tumor efficacy; To evaluate potential pharmacodynamic and predictive biomarkers at MTD.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Weight: male weight ≥ 45 kg; female weight ≥ 40 kg, body mass index (BMI) between 18\~24 kg/m\^2, including the boundary values;
- •The subject has a histologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival;
- •Not treated with standard therapeutical regime currently, or has progressed or relapsed after standard treatment;
- •Time from last cytotoxic chemotherapy (including investigational cytotoxic agents) or biologic agents (immune modulators, cytokines) ≥ 4 weeks, or nitrosoureas or mitomycin C ≥ 6 weeks. If having received an antibody anti-tumor biological product, at least 8-week washout period is required;
- •At least 4 weeks after surgery, and the wound must be healed completely;
- •If subject has chemotherapy-induced toxicity, the adverse events must be recovered to ≤ grade 1 (NCI-CTC version 4.0) except for alopecia;
- •ECOG performance status of 0-2;
- •Expected survival time is more than three months;
- •The subject has organ and marrow function as follows:
- •absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L,
Exclusion Criteria
- •The subject is known to be positive for the human immunodeficiency virus (HIV);
- •The subject is known to be positive for hepatitis B surface antigen or hepatitis C;
- •Previous participation in other clinical trials within three months before study;
- •Concomitant chemotherapy, hormone therapy, immunotherapy program or radiotherapy;
- •The subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia;
- •The subject has psychiatric illness/social situations that would limit compliance with study requirements;
- •The subject has brain metastases;
- •Imaging study showed involvement of major blood vessels or nerves by tumor;
- •Uncontrollable hypertension (referring to systolic blood pressure\> 150 mmHg and / or diastolic blood pressure\> 100 mmHg after treatment) or LVEF \<50%;
- •Patient with disease history of bleeding or thromboembolic events occurred within the past six months and need for preventive anticoagulant therapy;
Arms & Interventions
Metatinib Tromethamine
Experimental
Dose escalation is in accordance with the traditional "3 +3" design, and dose groups are subsequently set as: 25, 50, 100, 200, 300, 450, 600, 800 mg/d.
Intervention: Metatinib Tromethamine (Drug)
Outcomes
Primary Outcomes
Dose-limiting Toxicity (DLT)
Time Frame: up to day 32
Maximum Tolerated Dose (MTD)
Time Frame: up to day 32
Secondary Outcomes
- Cmax(d1、d2、d3、d8、d15、d22、d29、d30、d31)
- AUC(d1、d2、d3、d8、d15、d22、d29、d30、d31)
- Objective response rate (ORR)(week 4, week 10, week 16)
Investigators
Study Sites (1)
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