None listed
Conditions
Interventions
Drug : Enrolled patients will receive a 4-week cycle of riboceranib-paclitaxel combination therapy.
- Paclitaxel: 80mg/m2/day (day 1, 8, 15)
- Rivoceranib: 500mg qd daily (day 1-28)
The starting dose
Sponsors
Hallym University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age = 19 years of male and female 2) Subjects with histologically confirmed locally advanced or metastatic gastric cancer that have progressed after treatment with first-line fluoropyrimidine-based chemotherapy 3) Patients must have measurable disease based on RECIST 1.1 4) Patients must have adequate organ and marrow function 5) ECOG performance status 0-1 6) Patients with expected life expectancy of at least 12 weeks 7) Patients must be able to swallow and retain oral medications 8) Patients with no major gastrointestinal disease (e.g., chronic diarrhea) that interferes with drug absorption and no history of intestinal surgery (excluding total/partial gastric resection for gastric cancer) 9) Patients with the ability and willingness to comply with the study protocol during the trial period and during the course of follow-up 10) Patients who have signed and submitted the consent form for the study, including compliance with the research consent form and the requirements and restrictions listed in this protocol
Exclusion criteria
Exclusion criteria: 1) History of administration of taxanes (paclitaxel or docetaxel) or contraindication for paclitaxel treatment 2) Previous treatment with riboceranib or other systemic treatment with VEGF pathway inhibitors 3) History of another malignancy within 2 years prior to screening 4) Active central nervous system lesions 5) Therapeutic (not prophylactic) use of maximum doses of oral or parenteral anticoagulants or other thrombolytics (within 10 days prior to Day 1 of Cycle 1) 6) Co-administration with potent inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 7) Active bacterial infections that require systemic antibiotic therapy (including tuberculosis and syphilis) 8) History of HIV infection 9) Active hepatitis B or C or chronic hepatitis B or C requiring antiviral or prophylactic antiviral therapy 10) Child-Pugh B or C liver dysfunction 11) Pregnant or lactating women or patients unwilling to comply with contraceptive requirements 12) History of uncontrolled hypertension 13) Symptomatic congestive heart failure (NYHA class III-IV), symptomatic and poorly controlled cardiac arrhythmias, complete left bundle branch block, bifascicular block, or clinical ST-segment and/or T-wave abnormality, QTcF>450 msec for men and QTcF>470 msec for women before screening 14) Clinically significant bleeding history within 14 days before Day 1 of Cycle 1 15) A history of clinically significant thrombosis within 3 months before the D1 of Cycle 1, which may put the patient at risk of side effects due to anti-angiogenic drugs according to the opinion of the investigator 16) History of other significant cardiovascular or vascular disease within 6 months prior to screening that could pose a risk to the patient due to VEGFR inhibitory therapy (e.g., myocardial infarction or unstable angina, stroke or transient cerebral ischemia, or significant peripheral vascular disease) 17) History of clinically significant glomerulonephritis, biopsy-proven tubulointerstitial nephritis, crystal nephropathy, or other renal failure 18) Psychological, familial, social, or geographic conditions (including substance abuse or alcohol abuse) that prevent compliance with trial participation or evaluation of trial results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR), Disease control rate(DCR), Overall survival(OS), Safety and Compliance | — |
Countries
Korea, Republic of
Contacts
Public ContactSukyeon Bae
Hallym University Medical Center
Outcome results
None listed