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troxacitabine

Phase 2

Leukemia | Small molecule | Oncology |Takeda Pharmaceutical Company Limited|Trials Updated: Jun 10, 2021

troxacitabine development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Feb 2004

troxacitabine target and mechanism

Molecular targetPOLA1, POLD4, POLD3, POLD1, POLD2, POLE
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

troxacitabine clinical trials

troxacitabine · 1 trial · 1 indication

Phase 2 1
NCT00012259Troxacitabine in Treating Patients With Chronic Myelogenous LeukemiaLeukemia
COMPLETED31 Analytics
PHASE2COMPLETED
Troxacitabine in Treating Patients With Chronic Myelogenous Leukemia
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Study Endpoints

Primary Endpoints

Conventional Response Rate
Week 4

Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).

Secondary Endpoints

Percent of Patients Returning to Chronic Phase
Throughout the study period of approximately 15 months.
Toxicity Profile
Every 4 weeks throughout the study period of approximately 15 months.
Survival Duration
Throughout the study period of approximately 15 months.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
troxacitabineEXPERIMENTAL -

Interventions

NameTypeDescription
troxacitabineDRUG -
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Eligibility Criteria

Age Range16 Years to 120 Years
SexALL
Healthy VolunteersNo
Study Sites20

DISEASE CHARACTERISTICS: Diagnosis of Philadelphia chromosome-positive blastic phase chronic myelogenous leukemia (CML) with blasts of non-lymphoid origin Blastic phase defined as: At least 30% blasts in the blood or bone marrow OR Presence of extramedullary infiltration outside the liver or spleen ...

Countries:United StatesCanada
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Competitive Landscape -Leukemia 435 trials

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Frequently asked questions about troxacitabine

What is troxacitabine used for?

Troxacitabine is an investigational small molecule being studied for the treatment of leukemia, specifically chronic myelogenous leukemia. It has been evaluated in a Phase 2 clinical trial in patients with this condition. It is not an approved therapy and remains in clinical development.

What does troxacitabine target?

Troxacitabine targets DNA polymerases, including POLA1, POLD1, POLD2, POLD3, POLD4, and POLE. It acts as an inhibitor of these enzymes. By inhibiting DNA polymerases, troxacitabine interferes with DNA synthesis and replication in cancer cells.

Who is developing troxacitabine?

Troxacitabine is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is responsible for its clinical development in leukemia.

What phase is troxacitabine in?

Troxacitabine is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 2 trial evaluating it in chronic myelogenous leukemia has been completed.

What clinical trials is troxacitabine in?

Troxacitabine has been studied in one completed Phase 2 trial, NCT00012259, titled "Troxacitabine in Treating Patients With Chronic Myelogenous Leukemia." The trial enrolled 31 patients in the United States and Canada. It was an uncontrolled, non-randomized study.