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tacedinaline

Phase 3

Lung Cancer | Small molecule | Oncology |Pfizer, Inc.|Trials Updated: Aug 10, 2012

tacedinaline development status

Highest phase Phase 3
Registered trials 2 across 1 sponsor since Jun 2004

tacedinaline target and mechanism

Molecular targetHDAC1, HDAC3, HDAC6, HDAC2, HDAC5, HDAC7
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials2
Total Enrollment -

FDA Designations

No designations recorded

tacedinaline clinical trials

tacedinaline · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT00005093Gemcitabine With or Without CI-994 in Treating Patients With Advanced Non-small Cell Lung CancerLung Cancer
COMPLETED- Analytics
PHASE3COMPLETED
Gemcitabine With or Without CI-994 in Treating Patients With Advanced Non-small Cell Lung Cancer
Lung CancerUnlock trial analytics

Study Design & Arms

AllocationRANDOMIZED
PurposeTREATMENT

Interventions

NameTypeDescription
gemcitabine hydrochlorideDRUG -
tacedinalineDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent, locally advanced, or metastatic, unresectable non-small cell lung cancer Failed or relapsed after one prior platinum containing regimen (cisplatin or carboplatin) as first line therapy Prior brain metastases allowed if res...

Countries:United StatesCanada
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Competitive Landscape -Lung Cancer 400 trials

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Frequently asked questions about tacedinaline

What is tacedinaline used for?

Tacedinaline is an investigational small molecule being studied in oncology for the treatment of lung cancer and pancreatic cancer. It has been evaluated in clinical trials in combination with gemcitabine in patients with advanced non-small cell lung cancer and advanced pancreatic cancer. It is not an approved therapy.

What does tacedinaline target?

Tacedinaline is a histone deacetylase (HDAC) inhibitor. It targets HDAC1, HDAC2, HDAC3, HDAC5, HDAC6, and HDAC7. By inhibiting these enzymes, tacedinaline affects histone acetylation and gene expression in cancer cells. This mechanism underlies its investigation as an anticancer agent in lung and pancreatic cancer.

Who is developing tacedinaline?

Tacedinaline is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer conducted the clinical trials evaluating tacedinaline in combination with gemcitabine for advanced lung and pancreatic cancers.

What phase is tacedinaline in?

Tacedinaline has reached Phase 3 clinical development. A Phase 3 trial evaluated it in advanced non-small cell lung cancer, and a Phase 2 trial evaluated it in advanced pancreatic cancer. Both trials are completed. Tacedinaline is investigational and has not been approved by the FDA.

What clinical trials is tacedinaline in?

Tacedinaline has been studied in two completed trials. NCT00005093 was a Phase 3 trial of gemcitabine with or without CI-994 in advanced non-small cell lung cancer. NCT00004861 was a Phase 2 trial of gemcitabine with or without CI-994 in advanced pancreatic cancer. Both enrolled adults in the United States and Canada.

Is tacedinaline the same as CI-994?

Yes, tacedinaline is also known as CI-994. The clinical trials for this HDAC inhibitor were conducted under the CI-994 designation, including NCT00005093 in lung cancer and NCT00004861 in pancreatic cancer. Tacedinaline and CI-994 refer to the same investigational compound developed by Pfizer.