Recent Updates
Recently added Catalysts

TAP-144

Phase 3

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment167

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

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 -
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about TAP-144

What is TAP-144 used for?

TAP-144 is an investigational small molecule being studied for the treatment of premenopausal breast cancer and prostate cancer. It is being developed by Takeda Pharmaceutical Company Limited (TAK) and is currently in Phase 3 clinical development.

What does TAP-144 target?

TAP-144 is a small molecule, but its specific molecular target has not been disclosed in available information. It is being studied in oncology indications, specifically premenopausal breast cancer and prostate cancer.

Who makes TAP-144?

TAP-144 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is currently in Phase 3 clinical trials for premenopausal breast cancer and prostate cancer.

What phase is TAP-144 in?

TAP-144 is in Phase 3 clinical development. It has completed one Phase 3 trial in prostate cancer and one Phase 3 trial in premenopausal breast cancer, both conducted in Japan.

What clinical trials is TAP-144 in?

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

Is TAP-144 the same as TAP-144-SR?

TAP-144 is also known as TAP-144-SR, as referenced in the clinical trial titles. The trials evaluated TAP-144-SR(6M), a formulation of the drug, in prostate cancer and premenopausal breast cancer patients.