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Ascorbate

Phase 1

Ovarian Cancer | Small molecule | Oncology |CNS Pharmaceuticals, Inc.|Last Updated: Jun 19, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

Ascorbate · 1 trial · 1 indication

Phase 1 1
NCT00228319Treatment of Newly Diagnosed Ovarian Cancer With AntioxidantsOvarian Cancer
COMPLETED27 Analytics
PHASE1COMPLETED
Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants
Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse events by NCI CTC version 3.0
At each oncology clinic visit

Secondary Endpoints

Quality of Life Questionnaire
once a month for 6 months and the end of the study
Blood chemistry
At each oncology clinic visit
CA-125 analysis
At each oncology clinic visit
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Standard of Care GroupACTIVE_COMPARATORcarboplatin and paclitaxel chemotherapy
Standar of Care + Ascorbic Acid GroupEXPERIMENTALcarboplatin and paclitaxel chemotherapy, plus intravenous sodium ascorbate. In addition, participants will take a mix of vitamins including oral ascorbic acid, oral mixed natural carotenoids with vitamin A and oral vitamin E.

Interventions

NameTypeDescription
Oral Ascorbic AcidDIETARY_SUPPLEMENT4 grams per day for 12 months
PaclitaxelDRUGSix cycles
CarboplatinDRUGSix cycles
Sodium AscorbateDRUGIntravenous infusion at 0.5 gram/min twice weekly over 1-2 hours at a dose to achieve levels of 400 mg/dl for 12 months
Oral Mixed natural Carotenoids with Vitamin ADIETARY_SUPPLEMENTCapsule containing mixed carotenoids and vitamin A. Participant to take 1 daily for 12 months
Vitamin EDIETARY_SUPPLEMENT500 IU per capsule and participant to take 1 capsule daily for 12 months
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * histologically confirmed carcinoma of the ovary stage III or IV * measurable or assessable disease * drug refractory ovarian cancer * must be 18 years of age or must have parental consent to enroll in the study * must be ambulatory Exclusion Criteria: * evidence of significa...

Countries:United States
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Competitive Landscape -Ovarian Cancer 176 trials

Top 20 of 59 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel
AstraZeneca PLCAZN19PHASE3Olaparib
GSK plc Sponsored ADRGSK4PHASE3Niraparib
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Pfizer Inc.PFE4PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel/m^2, Relacorilant once daily
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Xencor, Inc.XNCR3PHASE2vudalimab
Exelixis, Inc.EXEL2PHASE2Cabozantinib
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Frequently asked questions about Ascorbate

What is Ascorbate used for in Ovarian Cancer?

Ascorbate is an investigational small molecule being studied for the treatment of ovarian cancer. It is currently in Phase 1 clinical development, with one completed trial involving 27 participants in the United States. The drug is being developed by CNS Pharmaceuticals, Inc. (NASDAQ: CNSP).

Who makes Ascorbate?

Ascorbate is being developed by CNS Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker CNSP. The company is conducting clinical research on this investigational small molecule for ovarian cancer, with a completed Phase 1 trial in the United States.

What phase is Ascorbate in?

Ascorbate is in Phase 1 clinical development for ovarian cancer. The drug is investigational and has not been approved by regulatory authorities. One Phase 1 trial has been completed, involving 27 female participants aged 18 years and older in the United States.

What clinical trials is Ascorbate in?

Ascorbate has one completed clinical trial, identified as NCT00228319, titled "Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants." This Phase 1 study enrolled 27 participants with ovarian cancer in the United States. The trial was active-controlled and randomized, though it was not double-blinded.

Is Ascorbate the same as vitamin C?

Ascorbate is a form of vitamin C, also known as ascorbic acid. In the context of this clinical research, it is being investigated as a potential treatment for ovarian cancer. The drug is in Phase 1 development by CNS Pharmaceuticals, Inc. (NASDAQ: CNSP).