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fruquintinib+paclitaxel

Phase 1

Gastric Cancer | Small molecule | Oncology |HUTCHMED (China) Limited|Last Updated: Feb 17, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment34
FDA Designations
PRIORITY_REVIEWBREAKTHROUGH_THERAPY
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02415023A Phase Ib/2 Clinical Study of Fruquintinib Combined With Paclitaxel in the Treatment of Advanced Gastric CancerPHASE1 COMPLETED 34Nov 9, 2014Mar 31, 2017Feb 17, 20203 China
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Study Endpoints
Primary Endpoints
incidence of DLT
every subject's DLT observation window is 4 weeks
progression free survival of RP2D
from first dose up to progressive disease or EOT due to any cause, assessed up to 1 year

using RECIST v1.1 progressive disease (PD), using RECIST v 1.1

safety and tolerance
From first dose to within 30 days after the last dose

Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 4.0.

Secondary Endpoints
Objective response rate (ORR)
from first dose up to progressive disease or EOT due to any cause, assessed up to 1 year]
Disease control rate (DCR)
From first dose up to progressive disease or EOT due to any cause, assessed up to 1 year]
Pharmacokinetic profiles of Fruquintinib combined with Paclitaxel
From first dose up to day 15 in the first 28-day cycle
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
fruquintinib+paclitaxelEXPERIMENTALfruquintinib combined with paclitaxel. Fruquintinib treatment: administration for 3 weeks followed by 1-week break, and administration every day for the first 21 days.Paclitaxel is administered once weekly in the first three weeks of each cycle.
Interventions
NameTypeDescription
fruquintinib+paclitaxelDRUG28-day cycle of fruquintinib qd for 3 weeks followed by 1-week break combined with paclitaxel 80 mg/m2
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Fully understand the study and sign the informed consent form voluntarily; 2. Patients with local advanced and/or metastatic gastric cancer confirmed by histology and/or cytology; 3. Fail in previous first-line standard chemotherapy 4. Aged 18-70years (inclusive); 5. Body wei...

Countries:China
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Competitive Landscape -Gastric Cancer 118 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN16PHASE3AZD0901, Ramucirumab+ paclitaxel, Paclitaxel, Docetaxel, Irinotecan
BeOne Medicines Ltd. Sponsored ADRONC4PHASE3Tislelizumab, Cisplatin, Leucovorin, 5-fluorouracil, Oxaliplatin
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Tislelizumab, Trastuzumab, Capecitabine, Oxaliplatin
Merck & Co., Inc.MRK1PHASE3pembrolizumab, cisplatin, 5-FU, leucovorin, levoleucovorin
Amgen Inc.AMGN2PHASE3Bemarituzumab, Nivolumab, Chemotherapy, CAPOX, SOX
Arcus Biosciences, Inc.RCUS2PHASE3Domvanalimab, Zimberelimab, Capecitabine, Fluorouracil, Leucovorin
Bristol-Myers Squibb CompanyBMY7PHASE2Pumitamig, Folfox, Capox, Nivolumab, BMS-986340
Pfizer Inc.PFE7PHASE2tucatinib, trastuzumab, oxaliplatin, leucovorin, fluorouracil
Agenus Inc.AGEN2PHASE3Balstilimab, Botensilimab, Folfox Protocol, XELOX, Nivolumab
AbbVie, Inc.ABBV2PHASE2Telisotuzumab Adizutecan, Budigalimab, Fluorouracil, Leucovorin, Oxaliplatin
Eli Lilly and CompanyLLY2PHASE2Ramucirumab, Paclitaxel, LY4337713
Compass Therapeutics, Inc.CMPX1PHASE2CTX-009, Paclitaxel
ALX Oncology Holdings, Inc.ALXO1PHASE2Evorpacept, Trastuzumab, Ramucirumab, Paclitaxel
GE Healthcare Technologies Inc.GEHC1PHASE2GEH300079 Positron-Emission Tomography /Computed Tomography
ImmunityBio IncIBRX1PHASE2N-803 + Pembrolizumab
Apollomics Inc. Class AAPLM1PHASE2APL-101
Exelixis, Inc.EXEL2PHASE1cabozantinib, atezolizumab, Cabozantinib, Durvalumab, Tremelimumab
Inhibrx Biosciences, Inc.INBX1PHASE1INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab, Carboplatin AUC-5, Pemetrexed /m2, Cisplatin /m2
Tango Therapeutics, Inc.TNGX2PHASE2Trifluridine/Tipiracil, Oxaliplatin, FOLFOX regimen, Nivolumab, S095029
I-Mab Biopharma US LimitedIMAB2PHASE2Givastomig, Nivolumab, 5Fluorouracil, Leucovorin, Oxaliplatin
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