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Hydrogen Peroxide

Phase 1

Breast Cancer | Small molecule | Oncology |United Therapeutics Corporation|Last Updated: Nov 27, 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
RandomizedNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02757651KORTUC: Intra-tumoural Hydrogen Peroxide as a Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer in Terms of Toxicity and Tumour ResponsePHASE1 COMPLETED 12 — — Jan 19, 2017Nov 12, 2020Nov 27, 20201 United Kingdom
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Study Endpoints
Primary Endpoints
Phase I: Patient reported maximum intra-tumoural pain intensity over duration of treatment
During radiotherapy
Phase II: Tumour response 3 months post-radiotherapy according to RECIST 1.1 criteria
3 months months post radiotherapy
Secondary Endpoints
Phase I: Proportion of patients with severe pain at any time before and up to 24 hours after any of the KORTUC injections. Server Sever pain is defined as scoring a max grade ≥5 above baseline
During radiotherapy and 3 months post radiotherapy
Phase II: Proportion of patients with severe pain at any time before and up to 24 hours after any of the KORTUC injections. Server pain is defined as scoring a max grade ≥5 above baseline Frequency and duration of pain score ≥1 at each time point
During radiotherapy & 3 and 24 months post radiotherapy
Phase I: Tumour response 3 months post- radiotherapy according to RECIST 1.1 criteria
3 months post radiotherapy
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Radiotherapy + radiation sensitizerEXPERIMENTALPatients in phase I and patients randomised to the test group in phase II will receive standard radiotherapy for breast cancer + a radiation sensitizer
Radiotherapy aloneNO_INTERVENTIONPatients randomised to the control group in phase II will receive standard radiotherapy for breast cancer alone.
Interventions
NameTypeDescription
Hydrogen PeroxideDRUGHydrogen Peroxide
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age over 18 years * Primary locally advanced breast cancer, or locally recurrent breast cancer with/without metastases * Radical/high dose palliative radiotherapy required for lifetime control of local morbidities * Patient physically and mentally fit for radical/high dose pal...

Countries:United Kingdom
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Competitive Landscape -Breast Cancer 408 trials
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