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Hydrogen Peroxide

Phase 1

Breast Cancer | Small molecule | Oncology |United Therapeutics Corporation|Last Updated: Nov 27, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Hydrogen Peroxide · 1 trial · 1 indication

Phase 1 1
NCT02757651KORTUC: Intra-tumoural Hydrogen Peroxide as a Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer in Terms of Toxicity and Tumour ResponseBreast Cancer
COMPLETED12 Analytics
PHASE1COMPLETED
KORTUC: Intra-tumoural Hydrogen Peroxide as a Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer in Terms of Toxicity and Tumour Response
Breast CancerUnlock trial analytics

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 to 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 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about Hydrogen Peroxide

What is Hydrogen Peroxide used for in breast cancer?

Hydrogen Peroxide is being studied as an intra-tumoural radiation sensitizer in patients with locally advanced or recurrent breast cancer. It is administered directly into the tumour to enhance the effects of radiation therapy. The drug is currently in Phase 1 clinical development for this oncology indication.

What does Hydrogen Peroxide target?

Hydrogen Peroxide does not target a specific molecular target. Instead, it acts as a radiation sensitizer when injected intra-tumourally. Its mechanism involves increasing the oxygen concentration in the tumour microenvironment, which can enhance the effectiveness of radiation therapy in treating breast cancer.

Who makes Hydrogen Peroxide?

Hydrogen Peroxide is being developed by United Therapeutics Corporation, a biopharmaceutical company listed on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical research to evaluate the drug's safety and efficacy as a radiation sensitizer for breast cancer treatment.

What phase is Hydrogen Peroxide in?

Hydrogen Peroxide is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 clinical trial has been completed to assess its toxicity and tumour response when used as an intra-tumoural radiation sensitizer in breast cancer patients.

What clinical trials is Hydrogen Peroxide in?

Hydrogen Peroxide has one completed Phase 1 clinical trial registered under NCT02757651. The trial, titled 'KORTUC: Intra-tumoural Hydrogen Peroxide as a Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer in Terms of Toxicity and Tumour Response,' enrolled 12 participants in the United Kingdom.

Is Hydrogen Peroxide the same as KORTUC?

Hydrogen Peroxide is the active drug being studied in the KORTUC clinical trial. KORTUC is the trial acronym, not an alternative name for the drug itself. The trial evaluates intra-tumoural hydrogen peroxide as a radiation sensitizer for locally advanced or recurrent breast cancer.