This study was conducted as a second-line treatment of recurrent / progressive gastric cancer patients with FGFs / FGFRs genetic mutations in the Ib / II clinical trial. The maximum maximal tolerated dose (MTD) and 2-phase recommended dose in combination with INCB054828 and paclitaxel (recommended phase II dose, RP2D), and evaluate the safety and clinical efficacy of this combination therapy. This study consists of two steps: Phase 1 is a dose escalation study to determine the maximum tolerated dose and 2-phase recommended dose of weekly paclitaxel and INCB054828 combination therapy, and Phase 2 is the dose escalation study in combination with INCB054828 and paclitaxel Assess safety and tolerability and identify antitumor effects in stomach cancer with FGFs / FGFRs genetic mutations.
1. phase\> \- Approximately 3-12 patients will be enrolled. The dose escalation will be three patients registered for each cohort until the first dose-limiting toxicity appears during the four weeks of treatment and observation. 13.5mg, once a day begins to take. The paclitaxel is administered once a week for three consecutive weeks and then for one week, followed by a total of four weeks in one cycle. 2. phase\> Phase 2 studies will be extended to a total of 30 patients with a two-phase recommended dose. Patients will be treated until the time of disease progression, intolerable toxicity, rejection of the patient, or withdrawal of consent. In its pre-screening phase, its next generation sequencing (NGS) is performed. Patients with FGFs / FGFRs genetic abnormalities may be enrolled in this study. If a patient has multiple genetic abnormalities, he or she will first be enrolled in a treatment group that targets a rare genetic abnormality. Registered patients will be treated on a continuous basis every four weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
phase 1\> \- Approximately 3-12 patients will be enrolled. The dose escalation will be three patients registered for each cohort until the first dose-limiting toxicity appears during the four weeks of treatment and observation. phase 2\> Phase 2 studies will be extended to a total of 30 patients with a two-phase recommended dose. Patients will be treated until the time of disease progression, intolerable toxicity, rejection of the patient, or withdrawal of consent.
Yonsei University Health System, Severance Hospital
Seoul, South Korea
MTD
Part 1, Phase Ib Maximum Tolerated dose (MTD)
Time frame: 4 weeks
Recommended phase 2 dose (RP2D)
Part 1, Phase Ib Recommended phase 2 dose as determined by Dose limiting Toxicity (DLT).
Time frame: 4 weeks
PFS
Prart 2, Phase II Progression-free survival (PFS): PFS is defined as the interval between the date of first dose and the earliest date of disease progression or death due to any cause.
Time frame: 24 weeks
ORR
Objective Response Rate (ORR): The duration of response. ORR is defined as the percentage of subjects with a confirmed CR or PR per RECIST v1.1
Time frame: 3 years
DCR
Disease Control Rate (DCR): DCR is the proportion of randomized patients achieving a best overall response of CR, PR, or SD.
Time frame: 3 years
OS
Overall Survival (OS): OS is the time from the date of first dose and the date of death from any cause.
Time frame: 3 years
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Safety and tolerability of the Varlitinib and Paclitaxel combination therapy as determined by: adverse events (categorized in accordance with CTCAE 4.03).
Time frame: 3 years
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