A Pharmacokinetic Interaction Study Between Apatinib Mesylate and Repaglinide or Bupropion in Advanced Solid Tumor Subjects

  • STATUS
    Recruiting
  • participants needed
    18
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 16 February 2024
bupropion
blood transfusion
solid tumor
targeted therapy
mitomycin
nitrosoureas
g-csf
colony stimulating factor
repaglinide
apatinib
advanced solid tumor
cytostatic drugs

Summary

The primary objective of the study was to assess investigate the pharmacokinetic effects of Apatinib Mesylate on CYP2C8 Substrate Repaglinide or CYP2B6 Substrate Bupropion and metabolite Hydroxy bupropion in Advanced solid tumor subjects.

The secondary objective of the study was to assess the safety of Apatinib or/and Repaglinide and Bupropion.

Details
Condition Advanced Solid Tumor
Age 18years - 70years
Treatment Apatinib Mesylate, Bupropion, Repaglinide
Clinical Study IdentifierNCT04457180
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on16 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

b'Age: 18-70 years old (Include both values); 2. Patients with histopathologically or'
b'cytologically confirmed advanced solid tumor (not necessary to have measurable lesions); 3.'
b'Refractory or intolerant to standard treatment regimens, or no effective standard treatment'
b'regimens available, or the patients refused to use standard treatment plan 4. ECOG PS'
b'core: 0-1; 5. Expected survival \\u2265 3 months; 6. Subjects have recovered from other'
b'treatments, at least 6 weeks since the last use of nitrosourea or mitomycin; at least 4'
b'weeks since the last use of small molecule targeted therapy; at least 5 half-lives since'
b'the last use of biological macromolecular therapy; at least 4 weeks since radiotherapy or'
b'urgery; at least 4 weeks since the last use of other cytotoxic or cytostatic drugs; 7.'
b'Major organs must function normally, meeting the following criteria:'
b'Hematology (no blood transfusion or blood products within the last 14 days, not'
b'corrected with G-CSF or other hematopoietic colony-stimulating factors):'
b'HB\\u2265100 g/L;'
b'ANC\\u22651.5\\xd7109/L;'
b'PLT\\u226590\\xd7109/L;'
b'Blood biochemistry:'
b'TBIL\\u2264 1.25\\xd7ULN;'
b'ALT and AST\\u22642.5\\xd7ULN;'
b'AKPALP\\u22642.5\\xd7ULN;'
b'Serum Cr \\u2264 1.5 \\xd7 ULN or endogenous CrCl \\u2265 60 mL/min (Cockcroft-Gault formula);'
b'Albumin > 30 g/L; 8. Sign the ICF voluntarily, have good compliance, corporate'
b'with follow-up visits, and follow the study requirements.'

Exclusion Criteria

b'Gastric cancer; tumors with risk of bleeding which researchers evaluated. 2.'
b'Active brain metastasis (medically uncontrolled); 3. Symptomatic third space'
b'fluid that cannot be controlled by drainage or other methods; 4. Dysphagia,'
b'chronic diarrhea, or other factors affecting drug intake and absorption; 5.'
b'Uncontrolled hypertension; 6. Heart rate < 60, Grade II or greater myocardial'
b'ischemia or myocardial infarction, uncontrolled arrhythmias (QTc interval \\u2265 450'
b'ms in males and \\u2265 470 ms in females); 7. Contraindications to Repaglinide and'
b'Bupropion; 8. NYHA Class III-IV cardiac insufficiency or left ventricular'
b'ejection fraction (LVEF) < 50% by echocardiography; 9.Abnormal coagulation'
b'function (INR > 1.5 or prothrombin time (PT) > ULN + 4 s or APTT > 1.5 ULN),'
b'bleeding tendency or who are currently receiving thrombolytics; 10.'
b'Arterial/venous thrombosis within 6 months prior to the first dose; 11.Hemorrhage'
b'and thrombophilia; 12. Major surgery or with severe traumatic injury, fracture,'
b'or ulcer within 4 weeks prior to the first dose; 13. Abdominal fistula,'
b'gastrointestinal perforation or abdominal abscess within 6 months prior to the'
b'first dose; 14. Urine protein \\u2265 ++ or 24 h urine protein \\u2265 1.0 g as indicated by'
b'urinalysis; 15. Treatment with steroids for more than 50 days, or requires'
b'chronic steroid use; 16. Use of study drugs in other clinical trials within 4'
b'weeks prior to the first dose; 27. Use of drugs affected gastric acid secretion'
b'or cytochrome enzyme CYP2C8\\u3001CYP2B6\\u3001CYP2D6\\u3001CYP3A and transporter OATP1B1 within 4'
b'weeks prior to the first dose; 18. Use of Chinese medicine, traditional Chinese'
b'medicine preparation or health products within 2 weeks prior to the first dose;'
b'Unable to hold drugs that may prolong QT interval during the study (such as'
b'antiarrhythmics); 20.Drug abuse within 12 months before the first dose or'
b'positive drug screening; 21. Drinking or smoking addiction ; 22.Other factors'
b'affecting drug absorption, distribution, metabolism, excretion Within 48 hours\\uff1b'
b'Active hepatitis B (HBV-DNA\\u2265104 or 2000IU/ml) or C (Hepatitis C antibodies are'
b'positive and HCV-RNA is above the detection limit of the analytical method); 24.'
b'Active infection requiring antimicrobial therapies (such as antibacterials,'
b'antivirals, or antifungals); 25. Immunodeficiency, including positive results of'
b'HIV test or other acquired or congenital immunodeficiencies, or a history of'
b'organ transplantation; 26. Allergic constitution, or known allergies to drug'
b'components used in this study; 27. Pregnant or lactating women; 28. Other factors'
b'that may affect the progress or the conclusion of the study, as determined by the'
b'investigator.'
Clear my responses

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.