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TAK-700

Phase 1

Prostate Cancer | Small molecule | Oncology |Takeda Pharmaceutical Company Limited|Last Updated: Jul 30, 2019

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

TAK-700 · 1 trial · 1 indication

Phase 1 1
NCT01084655Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate CancerProstate Cancer
COMPLETED38 Analytics
PHASE1COMPLETED
Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) or Serious Adverse Events (SAE)
Baseline up to 30 days after last dose of study drug (Day of last dose for Phase 1: Cycle 84 Day 21; Phase 2: Cycle 48 Day 21)
Number of Participants With TEAEs Related to Hematology and Serum Chemistry
Baseline up to 30 days after last dose of study drug (Day of last dose for Phase 1: Cycle 84 Day 21; Phase 2: Cycle 48 Day 21)
Number of Participants With TEAEs Related to Vital Signs
Baseline up to 30 days after last dose of study drug (Day of last dose for Phase 1: Cycle 84 Day 21; Phase 2: Cycle 48 Day 21)
Number of Participants With TEAEs Related to Electrocardiogram (ECG)
Baseline up to 30 days after last dose of study drug (Day of last dose for Phase 1: Cycle 84 Day 21; Phase 2: Cycle 48 Day 21)
Phase 2: Cmax: Maximum Observed Plasma Concentration for Docetaxel
Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion
Phase 2: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Docetaxel
Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion
Phase 2: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Docetaxel
Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion
Phase 2: Terminal Phase Elimination Half-life (T1/2) for Docetaxel
Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion
Phase 2: Cmax, ss: Maximum Observed Plasma Concentration at Steady State for Orteronel
Cycle 1 Day 21: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel
Phase 2: AUC 0-tau: Area Under the Plasma Concentration Versus Time Curve Zero to the Time of the End of the Dosing Interval for Orteronel
Cycle 1 Day 21: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel
Phase 2: Percentage of Participants With Prostate-specific Antigen (PSA) Response of 30 Percent (%), 50%, and 90%
Cycle 4 Day 21

PSA response rates (PSA-30, PSA-50, and PSA-90) were defined as greater than or equal to (\>=) 30%, 50%, and 90% reductions, respectively, from baseline in PSA concentration.

Phase 2: Best PSA Response
Cycle 2 Day 1 up to Cycle 12 Day 21

Best PSA response was defined as the maximum PSA percent reduction from baseline at any time beyond Cycle 1.

Secondary Endpoints

Phase 2: Time to PSA Progression
Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months)
Phase 2: Time to Radiographic Disease Progression
Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months)
Phase 2: Percentage of Participants With Objective Measurable Disease Response
Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1: Orteronel 200 mg BID + Docetaxel + PrednisoneEXPERIMENTALOrteronel (TAK-700) 200 milligram (mg), tablets, orally, twice daily (BID) starting from Day 1 along with docetaxel 75 milligram per square meter (mg/m\^2), infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets , orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods.
Phase 1: Orteronel 400 mg BID + Docetaxel + PrednisoneEXPERIMENTALOrteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m\^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets , orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods.
Phase 2: Orteronel 400 mg BID + Docetaxel + PrednisoneEXPERIMENTALOrteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Cycle 1 Day 15 along with docetaxel 75 mg/m\^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 1 up to Day 21 of each 21-day treatment cycle until disease progression or end of treatment (EOT).

Interventions

NameTypeDescription
TAK-700DRUGTAK-700 with docetaxel and prednisone on a continuous schedule.
DocetaxelDRUGTAK-700 with docetaxel and prednisone on a continuous schedule.
PrednisoneDRUGTAK-700 with docetaxel and prednisone on a continuous schedule.
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Each patient must meet all of the following inclusion criteria: * Voluntary written consent * Male patients 18 years or older * Estimated life expectancy of 6 months or more * Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma * Radiograph-documented...

Countries:United States
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Competitive Landscape -Prostate Cancer 254 trials

Frequently asked questions about TAK-700

What is TAK-700 used for in prostate cancer?

TAK-700 is an investigational small molecule being studied for the treatment of prostate cancer, specifically in men with metastatic castration-resistant prostate cancer. It is being evaluated in combination with docetaxel and prednisone. As of the available data, TAK-700 is in Phase 1 clinical development and is not yet approved.

Who makes TAK-700?

TAK-700 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in prostate cancer. TAK-700 is an investigational agent and has not received regulatory approval.

What phase is TAK-700 in?

TAK-700 is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the drug in combination with docetaxel and prednisone in men with metastatic castration-resistant prostate cancer. The drug remains investigational and is not approved for any use.

What clinical trials is TAK-700 in?

TAK-700 has one completed clinical trial, NCT01084655, which was a Phase 1 study of TAK-700 in combination with docetaxel and prednisone in men with metastatic castration-resistant prostate cancer. The trial enrolled 38 participants in the United States and was a controlled, non-randomized, open-label study.

Is TAK-700 FDA approved?

TAK-700 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for prostate cancer. A Phase 1 trial has been completed, but the drug has not yet progressed to later-stage trials or received regulatory approval for any indication.