Status:
COMPLETED
A Pharmacokinetic Interaction Study Between Apatinib Mesylate and Transporter Pgp Substrate Digoxin in Advanced Solid Tumor Subjects
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Apatinib, an oral inhibitor of vascular endothelial growth factor receptor 2#VEGFR-2#, Induces Transporter Pgp function in vitro. This study in patients with advanced cancer evaluated the effect of Ap...
Eligibility Criteria
Inclusion
- 1\. Histologically or cytologically confirmed diagnosis of advanced solid tumors. 2. ECOG PS score: 0-1; 3. Expected survival ≥ 3 months; 4. Major organs must function normally, meeting the following criteria:
- Hematology
- HB≥100 g/L;
- ANC≥1.5×109/L;
- PLT≥90×109/L;
- Blood biochemistry:
- TBIL≤ 1.25×ULN;
- ALT and AST≤2.5×ULN;
- ALP≤2.5×ULN;
- Serum Cr ≤ 1.5 × ULN or endogenous CrCl ≥ 60 mL/min (Cockcroft-Gault formula);
- Albumin \> 30 g/L;
- K+\>3.0mmol/L; 5. Able to understand and sign an informed consent form (ICF).
Exclusion
- Primary liver cancer; gastric cancer;
- Active brain metastasis (medically uncontrolled), carcinomatous meningitis, spinal cord compression;
- Presence of clinically symptomatic third space fluid;
- Uncontrolled hypertension (SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg despite optimal pharmacological treatment);
- Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \>2 NYHA 2 congestive heart failure; (2) left ventricular ejection fraction (LVEF) \< 50% (3) heart rate \<60 (4) Grade II or greater myocardial ischemia or myocardial infarction(5) QTc interval ≥ 450 ms in males and ≥ 470 ms in females;
- Abnormal coagulation function;
- Prior radiotherapy, systemic chemotherapy (\< 6 weeks if chemotherapy including nitrosoureas or mitomycin), hormone therapy, surgery or target therapy within 4 weeks before the study drug administration, or any unresolved AEs \> CTC-AE Grade 1;
- History of psychotropic substance abuse, alcoholism or drug abuse;
- Use of study drugs in other clinical trials within 4 weeks prior to the first dose；
- Use of a potent CYP3A4 inhibitor or inducer within 2 weeks prior to the first dose;
- Use of any prescription or over-the-counter medication, vitamin products or herbs within 2 weeks before taking the investigational drug;
- Other factors that may lead to the termination of the participation in the study at the discretion of the investigators.
Key Trial Info
Start Date :
March 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04322552
Start Date
March 12 2020
End Date
May 3 2021
Last Update
November 7 2022
Active Locations (1)
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1
Hunan Cancer Hospital
Changsha, Hunan, China, 410013