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TAP-144

Phase 3

Premenopausal Breast Cancer | Small molecule | Oncology |Takeda Pharmaceutical Company Limited|Trials Updated: Nov 26, 2015

TAP-144 target and mechanism

ModalitySmall molecule

Also known as TAP-144-SR(6M)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment327

FDA Designations

No designations recorded

TAP-144 clinical trials

TAP-144 · 2 trials · 2 indications

Phase 3 2
NCT01546649A Phase 3 Comparative Study of TAP-144-SR(6M) in Postoperative and Hormone Therapy-naïve Patients With Premenopausal Breast CancerPremenopausal Breast Cancer
COMPLETED167 Analytics
NCT01546623A Phase 3 Comparative Study of TAP-144-SR(6M) in Prostate Cancer Patients Previously Treated With Hormonal TherapyProstate Cancer
COMPLETED160 Analytics
PHASE3COMPLETED
A Phase 3 Comparative Study of TAP-144-SR(6M) in Postoperative and Hormone Therapy-naïve Patients With Premenopausal Breast Cancer
Premenopausal Breast CancerUnlock trial analytics
PHASE3COMPLETED
A Phase 3 Comparative Study of TAP-144-SR(6M) in Prostate Cancer Patients Previously Treated With Hormonal Therapy
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Suppressive Effect of Serum Estradiol (E2) to Menopausal Level (=<30 pg/mL) From Week 4 Through Week 48
Week 4 up to Week 48

Comparison of both the treatment groups was done by assessing the suppressive effect on serum E2 concentration maintained at menopausal level (=\<30pg/mL). Suppression rate was calculated as proportion of participants maintained at menopausal level.

The Rate of Suppression of Serum Testosterone to Castrate Level
From the start of study drug administration through Week 48

Comparison of the proportion of patients maintained at castration level (≤100 ng/dL)

Secondary Endpoints

Concentration of Serum E2
Baseline, Hour (hr) 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673
Concentration of Serum Luteinizing Hormone (LH)
Baseline, Hour 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673
Concentration of Follicle Stimulating Hormone (FSH)
Baseline, Hour 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TAP-144-SR(6M)EXPERIMENTALTAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 96 weeks.
TAP-144-SR(3M)ACTIVE_COMPARATORTAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 96 weeks.

Interventions

NameTypeDescription
TAP-144-SR(6M)DRUG -
TAP-144-SR(3M)DRUG -
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Eligibility Criteria

Age Range20 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: 1. The participant has histopathologically-confirmed primary breast cancer in Japanese. 2. The participant is aged 20 years or older when informed consent is obtained 3. The participant has estrogen receptor (ER)-positive tumor cells and/or progesterone receptor (PgR)-positive p...

Countries:Japan
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Frequently asked questions about TAP-144

What is TAP-144?

TAP-144 is an investigational small molecule oncology drug developed by Takeda Pharmaceutical Company Limited. It is being studied in Phase 3 clinical trials for premenopausal breast cancer and prostate cancer. The drug is also known as TAP-144-SR(6M). It has been evaluated in Japan in randomized, active-controlled trials.

What is TAP-144 used for in premenopausal breast cancer?

TAP-144 is being studied for use in premenopausal breast cancer. A Phase 3 trial (NCT01546649) evaluated TAP-144-SR(6M) in postoperative and hormone therapy-naive patients with premenopausal breast cancer. The trial enrolled 167 female patients aged 20 years and older in Japan and has been completed.

What is TAP-144 used for in prostate cancer?

TAP-144 is being studied for use in prostate cancer. A Phase 3 trial (NCT01546623) evaluated TAP-144-SR(6M) in prostate cancer patients previously treated with hormonal therapy. The trial enrolled 160 male patients aged 20 years and older in Japan and has been completed.

Who makes TAP-144?

TAP-144 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the Phase 3 clinical trials evaluating TAP-144-SR(6M) in premenopausal breast cancer and prostate cancer.

What phase is TAP-144 in?

TAP-144 is in Phase 3 clinical development. It has been evaluated in two completed Phase 3 trials, one in premenopausal breast cancer and one in prostate cancer. TAP-144 is investigational and has not been approved by the FDA.

What clinical trials is TAP-144 in?

TAP-144 has been studied in two completed Phase 3 trials. NCT01546649 evaluated TAP-144-SR(6M) in postoperative and hormone therapy-naive patients with premenopausal breast cancer, enrolling 167 patients. NCT01546623 evaluated TAP-144-SR(6M) in prostate cancer patients previously treated with hormonal therapy, enrolling 160 patients. Both trials were conducted in Japan.

Is TAP-144 the same as TAP-144-SR(6M)?

Yes, TAP-144-SR(6M) is an alternative name for TAP-144. The two names refer to the same drug candidate developed by Takeda Pharmaceutical Company Limited. TAP-144-SR(6M) is the name used in the Phase 3 clinical trial titles for both premenopausal breast cancer and prostate cancer.