Prostate CancerPhase 1/2NCT01666314
Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer
A Phase 1/2 study testing Orteronel and Prednisone in people with Prostate Cancer, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a double-blind, placebo-controlled, multiregional Phase1/2 study to characterize the pharmacokinetic and pharmacodynamic responses to orteronel when administered concomitantly with prednisone in Chemotherapy-Naive Participants With 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?
- Orteronel and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2012to 1 Sep 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
- Male participants 18 years or older
- Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
- Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
- Prior surgical castration or concurrent use of an agent for medical castration [e.g. Gonadotropin-releasing hormone (GnRH) analogue]
- Prostate-Specific Antigen (PSA) ≥ 2 ng/mL at screening
- Progressive disease based on PSA and/or radiographic criteria
Who cannot join
- Prior therapy with orteronel, ketoconazole, aminoglutethimide, or abiraterone.
- Known hypersensitivity to compounds related to orteronel, orteronel excipients, prednisone (or commercially available equivalent), or GnRH analogue.
- All antiandrogen therapy (including bicalutamide) is excluded within 4 weeks before the first dose of study drug. Any other therapies for prostate cancer, other than GnRH analogue therapy, such as progesterone, medroxyprogesterone, progestins (megesterol), or 5- alpha reductase inhibitors (e.g., finasteride or dutasteride), must be discontinued 2 weeks before the first dose of study drug.
- Continuous daily use of oral prednisone (or commercially available equivalent), oral dexamethasone, or other systemic corticosteroids for more than 2 weeks within the 3 months before screening (inhaled, nasal, and local steroids [e.g., joint injection] are allowed).
- Prior chemotherapy for prostate cancer, with the exception of neoadjuvant/adjuvant therapy as part of initial primary treatment for local disease that was completed 2 or more years before screening.
- Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
- Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Patients With Castration-Resistant Prostate Cancer
This is a double-blind, placebo-controlled, multiregional Phase1/2 study to characterize the pharmacokinetic and pharmacodynamic responses to orteronel when administered concomitantly with prednisone in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer
Read the detailed description
The drug being tested in this study is called orteronel. Orteronel is being tested to treat adult males who have adenocarcinoma of the prostate. This study will look at the pharmacokinetics (how the drug moves through the body) and pharmacodynamics (how the drug effects the body) in people who take orteronel in addition to prednisone.
The study will enroll approximately 144 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the eight treatment groups (4 in Japan, 4 in Ex-Japan) which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).
In Japan:
Participants were randomized in a ratio of 2:1:2:1
- 200 mg orteronel or Placebo-matching orteronel [(dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient] twice daily (BID) + prednisone
- 300 mg orteronel, or Placebo-matching orteronel, BID + prednisone Ex-Japan Participants were randomized in a ratio of 2:1:2:1
- 200 mg orteronel or Placebo-matching orteronel, BID in Cycle 1 + prednisone
- 400 mg orteronel, or Placebo-matching orteronel ,BID in Cycle 1 + Prednisone
Participants initially randomized to placebo received 4 weeks of placebo and then 12 weeks of active treatment with orteronel then entered a follow-up period treatment period. Participants initially randomized to orteronel received 16 weeks of treatment then entered a follow-up treatment period.
This multi-centre trial will be conducted worldwide. The overall time to participate in this study is approximately 3.2 years. Participants will make multiple visits to the clinic and a final visit 30 to 40 days after receiving their last dose of study drug for a follow-up assessment.
- Conditions
- Prostate Cancer
- Being tested
- Orteronel, Orteronel Placebo, Prednisone
- Keywords
- castrate resistant prostate cancer,, CRPC,, orteronel,, TAK-700
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrteronelDrug
Orteronel tablets
Orteronel PlaceboDrug
Orteronel placebo-matching tablets
PrednisoneDrug
Prednisone 5 mg
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Orteronel 200 mg (Japan) | Other | Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days) followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study. Receives: Drug: Orteronel; Drug: Orteronel Placebo; Drug: Prednisone |
| Orteronel 200 mg (Japan) | Experimental | Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study. Receives: Drug: Orteronel; Drug: Prednisone |
| Placebo + Orteronel 300 mg (Japan) | Other | Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study. Receives: Drug: Orteronel; Drug: Orteronel Placebo; Drug: Prednisone |
| Orteronel 300 mg (Japan) | Experimental | Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study. Receives: Drug: Orteronel; Drug: Prednisone |
| Placebo + Orteronel 200 mg (Ex-Japan) | Other | Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles outside of Japan (Ex-Japan) for up to 3.1 years.
Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study. Receives: Drug: Orteronel |
| Orteronel 200 mg (Ex-Japan) | Experimental | Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study. Receives: Drug: Orteronel; Drug: Prednisone |
| Placebo + Orteronel 400 mg (Ex-Japan) | Other | Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study. Receives: Drug: Orteronel; Drug: Orteronel Placebo; Drug: Prednisone |
| Orteronel 400 mg (Ex-Japan) | Experimental | Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study. Receives: Drug: Orteronel; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Measured: Baseline and Week 4
Secondary outcomes (21)
Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Measured: Baseline and Week 4
Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Measured: Baseline and Week 4
Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Measured: Baseline and Week 12
Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment
A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.
Measured: Baseline and Week 4
Percentage of Participants With PSA50 After 12 Weeks of Treatment
A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.
Measured: Baseline and Week 12
Absolute Values for Testosterone
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Measured: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S)
Serum Ultra low level quantification of DHEA-S was measured by liquid chromatography and mass spectrometry (LC/MS) at a central laboratory.
Measured: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Absolute Values for Adrenocorticotropic Hormone (ACTH)
Serum ACTH was measured by immunometric assay at the central laboratory.
Measured: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Absolute Values for Corticosterone
Serum Corticosterone was measured by high pressure liquid chromatography with mass spectrometry at the central laboratory.
Measured: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Absolute Values for Cortisol
Serum Cortisol was measured by immunometric assay at the central laboratory.
Measured: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Absolute Values for Prostate-Specific Antigen (PSA)
Serum PSA was measured at the central laboratory.
Measured: Baseline and Cycle 2 Day 1
Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
AUC(0-12): Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours Post-dose for Orteronel and M-I Metabolite
AUC(0-12) is measure of area under the curve over the dosing interval where the length of the dosing interval is time 0 to 12 hours in this study.
Measured: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Measured: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
AE (0-24) Cumulative Amount of Drug Excreted Into the Urine for Orteronel and MI-Metabolite
Cumulative amount of urine excreted time 0 to 24 hour.
Measured: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
Cmax,ss: Maximum Observed Plasma Concentration at Steady State for Orteronel and MI-Metabolite
Maximum observed steady-state plasma concentration during a dosing interval.
Measured: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax), Equal to Time (Hours) to Cmax at Steady State for Orteronel and M-I Metabolite
Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax at steady state.
Measured: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Orteronel and M-I Metabolite
Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.
Measured: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
Rac: Accumulation Index for Orteronel and M-I Metabolite
Rac was calculated as the ratio of AUCtau to AUC12hr.
Measured: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
Ctrough,ss: Observed Predose Plasma Concentration at Steady State for Orteronel and M-I Metabolite
Observed predose plasma concentration at steady state.
Measured: Cycle 1 Day 8 Predose
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding),symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Measured: From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study start20 Aug 2012
- Primary completion12 Sep 2013
- Study completion1 Sep 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Millennium Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666314
- Sponsor's protocol ID
- C21013
- Other IDs
- 2012-001539-30, U1111-1179-5750
- Status last verified
- Feb 2018
- First submitted
- 6 Aug 2012
- Last updated
- 20 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Patients With Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT01666314
- Acronym / sponsor ID
- C21013
- Conditions
- Prostate Cancer
- Keywords
- castrate resistant prostate cancer,, CRPC,, orteronel,, TAK-700
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2012 (actual)
- Primary completion
- 12 Sep 2013 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 16 Aug 2012 (estimated)
- Results
- Posted 20 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind, placebo-controlled, multiregional Phase1/2 study to characterize the pharmacokinetic and pharmacodynamic responses to orteronel when administered concomitantly with prednisone in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer
Detailed description
The drug being tested in this study is called orteronel. Orteronel is being tested to treat adult males who have adenocarcinoma of the prostate. This study will look at the pharmacokinetics (how the drug moves through the body) and pharmacodynamics (how the drug effects the body) in people who take orteronel in addition to prednisone.
The study will enroll approximately 144 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the eight treatment groups (4 in Japan, 4 in Ex-Japan) which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).
In Japan:
Participants were randomized in a ratio of 2:1:2:1
- 200 mg orteronel or Placebo-matching orteronel [(dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient] twice daily (BID) + prednisone
- 300 mg orteronel, or Placebo-matching orteronel, BID + prednisone Ex-Japan Participants were randomized in a ratio of 2:1:2:1
- 200 mg orteronel or Placebo-matching orteronel, BID in Cycle 1 + prednisone
- 400 mg orteronel, or Placebo-matching orteronel ,BID in Cycle 1 + Prednisone
Participants initially randomized to placebo received 4 weeks of placebo and then 12 weeks of active treatment with orteronel then entered a follow-up period treatment period. Participants initially randomized to orteronel received 16 weeks of treatment then entered a follow-up treatment period.
This multi-centre trial will be conducted worldwide. The overall time to participate in this study is approximately 3.2 years. Participants will make multiple visits to the clinic and a final visit 30 to 40 days after receiving their last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Placebo + Orteronel 200 mg (Japan) | Other | Drug: Orteronel, Drug: Orteronel Placebo, Drug: PrednisoneOrteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days) followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study. |
| Orteronel 200 mg (Japan) | Experimental | Drug: Orteronel, Drug: PrednisoneOrteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study. |
| Placebo + Orteronel 300 mg (Japan) | Other | Drug: Orteronel, Drug: Orteronel Placebo, Drug: PrednisoneOrteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study. |
| Orteronel 300 mg (Japan) | Experimental | Drug: Orteronel, Drug: PrednisoneOrteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study. |
| Placebo + Orteronel 200 mg (Ex-Japan) | Other | Drug: OrteronelOrteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles outside of Japan (Ex-Japan) for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study. |
| Orteronel 200 mg (Ex-Japan) | Experimental | Drug: Orteronel, Drug: PrednisoneOrteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study. |
| Placebo + Orteronel 400 mg (Ex-Japan) | Other | Drug: Orteronel, Drug: Orteronel Placebo, Drug: PrednisoneOrteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study. |
| Orteronel 400 mg (Ex-Japan) | Experimental | Drug: Orteronel, Drug: PrednisoneOrteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male participants 18 years or older
- Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
- Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
- Prior surgical castration or concurrent use of an agent for medical castration [e.g. Gonadotropin-releasing hormone (GnRH) analogue]
- Prostate-Specific Antigen (PSA) ≥ 2 ng/mL at screening
Key exclusion criteria (7 listed)
- Prior therapy with orteronel, ketoconazole, aminoglutethimide, or abiraterone.
- Known hypersensitivity to compounds related to orteronel, orteronel excipients, prednisone (or commercially available equivalent), or GnRH analogue.
- All antiandrogen therapy (including bicalutamide) is excluded within 4 weeks before the first dose of study drug. Any other therapies for prostate cancer, other than GnRH analogue therapy, such as progesterone, medroxyprogesterone, progestins (megesterol), or 5- alpha reductase inhibitors (e.g., finasteride or dutasteride), must be discontinued 2 weeks before the first dose of study drug.
- Continuous daily use of oral prednisone (or commercially available equivalent), oral dexamethasone, or other systemic corticosteroids for more than 2 weeks within the 3 months before screening (inhaled, nasal, and local steroids [e.g., joint injection] are allowed).
- Prior chemotherapy for prostate cancer, with the exception of neoadjuvant/adjuvant therapy as part of initial primary treatment for local disease that was completed 2 or more years before screening.
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 |
|---|---|---|
| OrteronelOrteronel tablets | Drug | Orteronel 200 mg (Ex-Japan), Orteronel 200 mg (Japan), Orteronel 300 mg (Japan), Orteronel 400 mg (Ex-Japan), Placebo + Orteronel 200 mg (Ex-Japan), Placebo + Orteronel 200 mg (Japan), Placebo + Orteronel 300 mg (Japan), Placebo + Orteronel 400 mg (Ex-Japan) |
| Orteronel PlaceboOrteronel placebo-matching tablets | Drug | Placebo + Orteronel 200 mg (Japan), Placebo + Orteronel 300 mg (Japan), Placebo + Orteronel 400 mg (Ex-Japan) |
| PrednisonePrednisone 5 mg | Drug | Orteronel 200 mg (Ex-Japan), Orteronel 200 mg (Japan), Orteronel 300 mg (Japan), Orteronel 400 mg (Ex-Japan), Placebo + Orteronel 200 mg (Japan), Placebo + Orteronel 300 mg (Japan), Placebo + Orteronel 400 mg (Ex-Japan) |
Primary outcome
Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan
Time frame: Baseline and Week 4
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
21 secondary outcomes
Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan
Time frame: Baseline and Week 4
Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment
Time frame: Baseline and Week 4
Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment
Time frame: Baseline and Week 12
Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment
Time frame: Baseline and Week 4
Percentage of Participants With PSA50 After 12 Weeks of Treatment
Time frame: Baseline and Week 12
Absolute Values for Testosterone
Time frame: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S)
Time frame: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Absolute Values for Adrenocorticotropic Hormone (ACTH)
Time frame: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Absolute Values for Corticosterone
Time frame: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Absolute Values for Cortisol
Time frame: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Absolute Values for Prostate-Specific Antigen (PSA)
Time frame: Baseline and Cycle 2 Day 1
Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite
Time frame: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
AUC(0-12): Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours Post-dose for Orteronel and M-I Metabolite
Time frame: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite
Time frame: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
AE (0-24) Cumulative Amount of Drug Excreted Into the Urine for Orteronel and MI-Metabolite
Time frame: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
Cmax,ss: Maximum Observed Plasma Concentration at Steady State for Orteronel and MI-Metabolite
Time frame: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax), Equal to Time (Hours) to Cmax at Steady State for Orteronel and M-I Metabolite
Time frame: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Orteronel and M-I Metabolite
Time frame: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
Rac: Accumulation Index for Orteronel and M-I Metabolite
Time frame: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
Ctrough,ss: Observed Predose Plasma Concentration at Steady State for Orteronel and M-I Metabolite
Time frame: Cycle 1 Day 8 Predose
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- 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 Orteronel 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 6 inclusion and 7 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 20 Mar 2018. 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 20 Mar 2018). 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?
Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2018.