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Chlorogenic acid

Phase 1

Glioblastoma | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Nov 1, 2018

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
UNCONTROLLED
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02728349Tolerance and Pharmacokinetic Study of Chlorogenic Acid to Advanced GlioblastomaPHASE1 COMPLETED 26Apr 12, 2016Sep 13, 2017Nov 1, 20181 China
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Study Endpoints
Primary Endpoints
Number of adverse events
Within the first 30 days after the first dose of chlorogenic acid
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0,grade ≥3 (DLT)
Within the first 30 days after the first dose of chlorogenic acid
Maximum Tolerated Dose
Within the first 30 days after the first dose of chlorogenic acid
Area under the plasma concentration versus time curve (AUC) of chlorogenic acid
Within the first 30 days after the first dose of chlorogenic acid
Peak Plasma Concentration (Cmax) of chlorogenic acid
Within the first 30 days after the first dose of chlorogenic acid
Secondary Endpoints
Improvement in cancer-related symptoms
Within 1 year after the first dose of chlorogenic acid
disease control rate(DCR)
Within the first 30 days after the first dose of chlorogenic acid
objective response rate (ORR)
Within the first 30 days after the first dose of chlorogenic acid
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Chlorgenic acid, Treatment, powderEXPERIMENTALChlorogenic acid for injection(30mg/bottle) is white or off-white freeze-dried lump or powder,it can be easily dissolved in water, which solubility is 20%.
Interventions
NameTypeDescription
Chlorogenic acidDRUGChlorogenic acid for injection is polyphenols, micromolecular and un-endogenous substance. It might play the role of cancer treatment via balancing tumor micro-environmental immune status according to the stability and rationality of immunodeficiency and endogenous immune material expression around the tumor. Chlorogenic acid for injection is made from chlorogenic acid (purity≥98%) which is extracted from folium cortex eucommiae.Chlorogenic acid and its preparations have not been reported as chemical drug and marketed around the world.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients with pathologic or/and FNAC confirmation of advanced glioblastoma(WHO,III-IV grade) but without effective treatment or with treatment failure; 2. Between 18 and 65 years of age, KPS≥40; 3. According to RANO(2010), the parents will be eligible if one of the following ...

Countries:China
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