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TAK-165

Phase 1

Breast Neoplasm | Small molecule | Oncology |Takeda Pharmaceutical Company Limited|Last Updated: Feb 2, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

TAK-165 · 1 trial · 5 indications

Phase 1 1
NCT00034281Safety and Tolerability Study of TAK-165 in Subjects With Tumors Expressing HER2Breast Neoplasm
COMPLETED16 Analytics
PHASE1COMPLETED
Safety and Tolerability Study of TAK-165 in Subjects With Tumors Expressing HER2
Breast NeoplasmUnlock trial analytics

Study Endpoints

Primary Endpoints

Dose Limiting Toxicity
Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit
Maximum Tolerated Dose
Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit
Optimal Dosing for Phase II Studies.
End of Study.

Secondary Endpoints

Clinical Pharmacokinetic Profile of TAK-165
Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit
Response Evaluation Criteria in Solid Tumors Documentation of Objective Tumor Response.
Day 56
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TAK-165 QDEXPERIMENTAL -

Interventions

NameTypeDescription
TAK-165DRUGStarting dose of TAK-165 10 mg, tablets, orally, once daily with dose escalation to tolerability for 56 days.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Have advanced or metastatic cancer which is refractory to standard therapy or subjects for whom there is no known effective therapy. * Have a histologically or cytologically proven diagnosis of a solid tumor known to express HER2. * Have a predicted life expectancy of greater ...

Countries:United States
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Frequently asked questions about TAK-165

What is TAK-165 used for?

TAK-165 is an investigational small molecule being studied for the treatment of breast neoplasm. It was evaluated in a Phase 1 clinical trial in patients with tumors expressing HER2, including breast, pancreatic, lung, ovarian, and renal neoplasms. The drug is being developed by Takeda Pharmaceutical Company Limited.

What does TAK-165 target?

TAK-165 targets HER2, as it was studied in subjects with tumors expressing HER2. The Phase 1 trial enrolled patients with HER2-expressing tumors, including breast, pancreatic, lung, ovarian, and renal neoplasms, to evaluate the safety and tolerability of the drug.

Who makes TAK-165?

TAK-165 is being developed by Takeda Pharmaceutical Company Limited, a company listed on the stock exchange under the ticker TAK. The drug is an investigational small molecule in the oncology therapeutic area.

What phase is TAK-165 in?

TAK-165 is in Phase 1 clinical development. It has completed one Phase 1 trial, which was an uncontrolled, non-randomized, open-label study. The drug is not approved and remains investigational.

What clinical trials is TAK-165 in?

TAK-165 has been studied in one completed clinical trial, NCT00034281, titled "Safety and Tolerability Study of TAK-165 in Subjects With Tumors Expressing HER2." This Phase 1 trial enrolled 16 participants in the United States and included patients aged 18 years and older.

Is TAK-165 the same as any other drug?

TAK-165 is the primary name for this investigational drug. No alternative names have been reported in the clinical trial record. The drug is being developed by Takeda Pharmaceutical Company Limited for the treatment of HER2-expressing tumors.