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Fasting mimicking diet

Phase 2

Fasting Mimicking Diet | Unknown | Oncology |Amgen Inc.|Last Updated: Oct 24, 2019

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
RandomizedNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment131
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02126449DIetary REstriction as an Adjunct to Neoadjuvant ChemoTherapy for HER2 Negative Breast CancerPHASE2 COMPLETED 131 — — Feb 1, 2014Nov 1, 2018Oct 24, 201915 Netherlands
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Study Endpoints
Primary Endpoints
The percentage of patients with grade III/IV toxicity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version (NCI CTCAE) v4.03.
2 years

Phase II

The percentage of pCR.
4 years

Phase III

Secondary Endpoints
Clinical response measured by MRI (RECIST1.1) after 4 cycles chemotherapy.
4 years
Grade I/II side effects of chemotherapy according to NCI CTCAE v4.03.
4 years
Metabolic (Glucose, insulin, insulin-like growth factor-I (IGF-I), insulin-like growth factor binding protein 3 (IGF-BP3), free thyroxin (FT4), triiodothyronine (T3) and thyroid-stimulating hormone (TSH)) and inflammatory response (CRP) to chemotherapy.
4 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Fasting mimicking dietEXPERIMENTALShort term fasting using Fasting mimicking diet around neoadjuvant chemotherapy (AC\>T)
regular dietNO_INTERVENTIONStandard neoadjuvant chemotherapy (AC\>T)
Interventions
NameTypeDescription
Fasting mimicking dietOTHER -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Female patients with stage II or III (cT1cN+ or ≥T2 any cN, cM0) breast cancer receiving neoadjuvant AC-T * Measurable disease (breast and/or lymph nodes) * HER2 negative core biopsy Age ≥18 years * WHO performance status 0-2 * Adequate bone marrow function : white blood cells...

Countries:Netherlands
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