Prostate CancerPhase 1/2NCT01084655

Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer

A Phase 1/2 study testing TAK-700, Docetaxel and Prednisone in people with Prostate Cancer, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an open-label, multicenter, Phase 1/2 study of TAK-700 in combination with docetaxel and prednisone that will evaluate the safety and pharmacokinetics (PK) of the combination and will allow estimation of prostate-specific antigen (PSA) response in men with metastatic castration-resistant prostate cancer… Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: TAK-700, Docetaxel and Prednisone
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited States
Study dates: Jul 2010to Mar 2016
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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 metastatic disease

Show all 14Show fewer

Progressive disease
Prior surgical castration or concurrent use of an agent for medical castration
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Physical examination findings that are consistent with other study entry or exclusion criteria and identified but not excluded chronic conditions
Even if surgically sterilized, patients must Practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug, OR Abstain from heterosexual intercourse
Any use of opiates must be stable for at least 2 weeks prior to study entry
Meet screening laboratory values as specified in protocol
Suitable venous access

Who cannot join

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
Known hypersensitivity to TAK-700, docetaxel, prednisone or related compounds
Received any of the following within 30 days prior to the first dose of TAK-700: prior therapy with any investigational compound; prior herbal product known to decrease PSA; OR radiation therapy for prostate cancer
Received prior therapy with TAK-700, aminoglutethimide, ketoconazole or abiraterone (for Phase 1 only, patients previously treated with ketoconazole or abiraterone will be eligible if treatment with ketoconazole or abiraterone was discontinued at least 30 days prior to enrollment)
Received antiandrogen therapy within 4 weeks for flutamide and 6 weeks for all others prior to first dose of study drug
Received prior chemotherapy for prostate cancer

Show all 18Show fewer

Current spinal cord compression, bilateral hydronephrosis or neck outlet obstruction
Symptoms that investigator deems related to prostate cancer
Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
Uncontrolled cardiovascular condition
New York Heart Association Class (NYHA) Class III or IV
Uncontrolled hypertension despite medical therapy
Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
Unwilling or unable to comply with protocol
Major surgery or serious infection within 14 days of first dose of TAK-700
Life-threatening illness unrelated to cancer
Uncontrolled nausea, vomiting or diarrhea
Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of TAK-700

Trial locations and contacts

1 site in 1 country.

United States1 site

Alaska Clinical Research Center, LLC
Anchorage, Alaska, 99508

Other trials in United States

About this study

Official title: An Open-label Phase 1/2 Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer

Conditions: Prostate Cancer
Being tested: TAK-700, Docetaxel, Prednisone
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAK-700Drug
TAK-700 with docetaxel and prednisone on a continuous schedule.
DocetaxelDrug
TAK-700 with docetaxel and prednisone on a continuous schedule.
PrednisoneDrug
TAK-700 with docetaxel and prednisone on a continuous schedule.

Study groups in NCT01084655
Study group	Role	What they receive
Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone	Experimental	Orteronel (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. Receives: Drug: TAK-700; Drug: Docetaxel; Drug: Prednisone
Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone	Experimental	Orteronel (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. Receives: Drug: TAK-700; Drug: Docetaxel; Drug: Prednisone
Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone	Experimental	Orteronel (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). Receives: Drug: TAK-700; Drug: Docetaxel; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) or Serious Adverse Events (SAE)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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%
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.
Measured: Cycle 4 Day 21
Phase 2: Best PSA Response
Best PSA response was defined as the maximum PSA percent reduction from baseline at any time beyond Cycle 1.
Measured: Cycle 2 Day 1 up to Cycle 12 Day 21

Secondary outcomes (4)

Phase 2: Time to PSA Progression
Time to PSA progression was defined as (date of PSA progression) - (date of first dose of drug) + 1, where PSA progression was defined as: For participants whose PSA concentrations never declined before the end of Cycle 4 of treatment: a) >=25% increase over the baseline level and an increase in absolute PSA concentration >=2 ng/mL; For participants who initially experienced a PSA decline: a) >=25% increase in PSA above the nadir concentration and an increase in absolute PSA concentration >=2 ng/mL.
Measured: Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months)
Phase 2: Time to Radiographic Disease Progression
Time to Radiographic Disease Progression was defined as (date of Radiographic Disease progression) - (date of first dose of drug) + 1. Radiographic disease progression is defined as the presence of progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) criteria and/or bone scan progression determined according to second Prostate Cancer Clinical Trials Working Group (PCWG2) bone scan criteria.
Measured: 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
Percentage of participants with objective measurable disease response based assessment of complete response (CR), partial response (PR), stable disease or PD according to RECIST (Version 1.1). A CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to less than (<)10 millimeter (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter(s) or short axis of lymph nodes.
Measured: Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months)
Phase 2: Change From Baseline in Circulating Tumor Cells (CTCs)
Baseline is defined as the last scheduled observed measurement prior to the first dose of drug.
Measured: Cycle 2 Day 1, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 21 Day 1, End of treatment (approximately up to Cycle 48), Last assessment (30 days after last dose of study drug, approximately up to 1038 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Mar 2016

First posted10 Mar 2010 (estimated)
Study startJul 2010
Primary completionJan 2013
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01084655
Sponsor's protocol ID: C21003
Status last verified: Jul 2019
First submitted: 9 Mar 2010
Last updated: 30 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Phase 1/2 Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT01084655
Acronym / sponsor ID: C21003
Conditions: Prostate Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Jan 2013 (actual)
Study completion: Mar 2016 (actual)
First posted: 10 Mar 2010 (estimated)
Results: Posted 30 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone	Experimental	Drug: TAK-700, Drug: Docetaxel, Drug: PrednisoneOrteronel (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 + Prednisone	Experimental	Drug: TAK-700, Drug: Docetaxel, Drug: PrednisoneOrteronel (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 + Prednisone	Experimental	Drug: TAK-700, Drug: Docetaxel, Drug: PrednisoneOrteronel (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).

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

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 metastatic disease

Key exclusion criteria (18 listed)

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
Known hypersensitivity to TAK-700, docetaxel, prednisone or related compounds
Received any of the following within 30 days prior to the first dose of TAK-700: prior therapy with any investigational compound; prior herbal product known to decrease PSA; OR radiation therapy for prostate cancer
Received prior therapy with TAK-700, aminoglutethimide, ketoconazole or abiraterone (for Phase 1 only, patients previously treated with ketoconazole or abiraterone will be eligible if treatment with ketoconazole or abiraterone was discontinued at least 30 days prior to enrollment)
Received antiandrogen therapy within 4 weeks for flutamide and 6 weeks for all others prior to first dose of study drug

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAK-700TAK-700 with docetaxel and prednisone on a continuous schedule.	Drug	Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone, Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone, Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone
DocetaxelTAK-700 with docetaxel and prednisone on a continuous schedule.	Drug	Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone, Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone, Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone
PrednisoneTAK-700 with docetaxel and prednisone on a continuous schedule.	Drug	Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone, Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone, Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone

Primary outcome

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) or Serious Adverse Events (SAE)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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%
Time frame: 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
Time frame: 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.

4 secondary outcomes

Phase 2: Time to PSA Progression
Time frame: Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months)
Phase 2: Time to Radiographic Disease Progression
Time frame: 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
Time frame: Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months)
Phase 2: Change From Baseline in Circulating Tumor Cells (CTCs)
Time frame: Cycle 2 Day 1, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 21 Day 1, End of treatment (approximately up to Cycle 48), Last assessment (30 days after last dose of study drug, approximately up to 1038 days)

Results and safety

Results posted to the registry on 30 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone	6	0
Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone	8	2
Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone	24	5

Primary outcome: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) or Serious Adverse Events (SAE)

Time frame: 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. Unit: participants

Measure	Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone n = 6	Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone n = 8	Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone n = 23
TEAE	6	8	23
SAE	5	5	16

Population analysed: The safety analysis set included all participants who were enrolled and received at least 1 dose of orteronel.

Primary outcome: Number of Participants With TEAEs Related to Hematology and Serum Chemistry

Time frame: 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. Unit: participants

Measure	Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone n = 6	Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone n = 8	Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone n = 23
Neutropenia	3	4	8
Anaemia	2	0	6
Leukopenia	0	1	4
Leukocytosis	0	0	3
Neutrophil count decreased	1	2	4
Blood bilirubin increased	0	1	1
Blood creatinine increased	1	0	2
White blood cell count decreased	0	3	6

Population analysed: The safety analysis set included all participants who were enrolled and received at least 1 dose of orteronel.

Primary outcome: Number of Participants With TEAEs Related to Vital Signs

Time frame: 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. Unit: participants

Measure	Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone n = 6	Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone n = 8	Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone n = 23
Hypertension	3	2	1
Hypotension	1	0	1
Accelerated hypertension	0	0	1

Population analysed: The safety analysis set included all participants who were enrolled and received at least 1 dose of orteronel.

Primary outcome: Number of Participants With TEAEs Related to Electrocardiogram (ECG)

Time frame: 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. Unit: participants

Measure	Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone n = 6	Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone n = 8	Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone n = 23
Overall	1	0	1
Angina pectoris	1	0	1

Population analysed: The safety analysis set included all participants who were enrolled and received at least 1 dose of orteronel.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Part 1: Cycle 29 Day 21; Part 2: Cycle 12 Day 21).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone	5 of 6 (83.3%)	6 of 6 (100%)	Not reported
Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone	5 of 8 (62.5%)	8 of 8 (100%)	Not reported
Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone	16 of 23 (69.6%)	23 of 23 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Millennium Pharmaceuticals, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TAK-700, Docetaxel and Prednisone in people with Prostate Cancer, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) or Serious Adverse Events (SAE) (time frame: 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)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01084655.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.