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

NCT01666314 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: C210132012-001539-30U1111-1179-5750
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Prostate Cancer

Keywords

castrate resistant prostate cancer,; CRPC,; orteronel,; TAK-700

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 4

Secondary Outcomes (21)

• Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan

  Baseline and Week 4

• Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment

  Baseline and Week 4

• Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment

  Baseline and Week 12

• Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment

  Baseline and Week 4

• Percentage of Participants With PSA50 After 12 Weeks of Treatment

  Baseline and Week 12

Study Arms (8)

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.

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.

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.

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.

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.

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.

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.

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.

Drug: Orteronel; Drug: Prednisone

Interventions

Orteronel DRUG

Orteronel tablets

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 Placebo DRUG

Orteronel placebo-matching tablets

Placebo + Orteronel 200 mg (Japan); Placebo + Orteronel 300 mg (Japan); Placebo + Orteronel 400 mg (Ex-Japan)

Prednisone DRUG

Prednisone 5 mg

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (1)

Urology Cancer Center, PC

Omaha, Nebraska, 68130, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

orteronel; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Monitor

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: August 16, 2012
• Study Start: August 20, 2012
• Primary Completion: September 12, 2013
• Study Completion: September 1, 2016
• Last Updated: March 20, 2018
• Results First Posted: March 20, 2018

Record last verified: 2018-02

Locations

US (1)