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Isovorin

Phase 3

Colon Cancer | Small molecule | Oncology |Pfizer, Inc.|Trials Updated: Aug 13, 2009

Isovorin development status

Highest phase Phase 3
Registered trials 2 across 1 sponsor since Sep 2005

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials2
Total Enrollment850

FDA Designations

No designations recorded

Isovorin clinical trials

Isovorin · 2 trials · 2 indications

Phase 3 2
NCT00195585Study Evaluating Isovorin in Colon CancerColon Cancer
COMPLETED650 Analytics
NCT00195572Study Evaluating Isovorin in Advanced/Recurrent Gastric CancerGastric Cancer
COMPLETED200 Analytics
PHASE3COMPLETED
Study Evaluating Isovorin in Colon Cancer
Colon CancerUnlock trial analytics
PHASE3COMPLETED
Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer
Gastric CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Relapse-free survival time
Survival time

Secondary Endpoints

Disease-free survival time, survival time, safety
Response rate, duration of response, time to progression, safety, quality of life
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
IsovorinDRUG -
UFTDRUG -
TS-1DRUG -
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Eligibility Criteria

Age Range20 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Dukes C, Cure A colon cancer diagnosed histologically or cytologically * Normal organ function of bone marrow, heart, liver and kidney * Age 20-75 Other inclusion applies Exclusion Criteria: * Serious bone marrow suppression, infection, heart disease or complication * Famil...

Countries:Japan
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Frequently asked questions about Isovorin

What is Isovorin used for?

Isovorin is an investigational small molecule being studied for the treatment of colon cancer and gastric cancer. It is being developed by Pfizer, Inc. (NYSE: PFE) and is currently in Phase 3 clinical development for these oncology indications.

What does Isovorin target?

Isovorin is a small molecule therapeutic being developed for oncology indications. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being evaluated for its potential efficacy in treating colon cancer and gastric cancer.

Who makes Isovorin?

Isovorin is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with colon cancer and gastric cancer.

What phase is Isovorin in?

Isovorin is in Phase 3 clinical development. Two Phase 3 trials have been completed, one in gastric cancer and one in colon cancer. The drug is investigational and has not been approved by regulatory authorities for any indication.

What clinical trials is Isovorin in?

Isovorin has been studied in two completed Phase 3 clinical trials. NCT00195572 evaluated the drug in advanced or recurrent gastric cancer with 200 participants in Japan. NCT00195585 evaluated the drug in colon cancer with 650 participants in Japan. Both trials enrolled adults aged 20 years and older.

Is Isovorin the same as leucovorin?

Isovorin is a distinct drug product being developed by Pfizer. While it is a folate-based compound used in cancer treatment, its specific chemical identity and relationship to other folate derivatives have not been detailed in the clinical trial information available.