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Phase II Randomized Comparative Trial of TAK-700 (Orteronel) Versus Bicalutamide in Metastatic Prostate Cancer Patients Failing 1st Line Treatment With LHRH Agonists or Surgical Castration.

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Phase II Randomized Comparative Trial of TAK-700 (Orteronel) Versus Bicalutamide in Metastatic Prostate Cancer Patients Failing 1st Line Treatment With LHRH Agonists or Surgical Castration.

Inclusion Criteria

Inclusion criteria:

- Histologically confirmed diagnosis of prostate adenocarcinoma

- Metastatic disease in bone or other lesions documented by imaging. Abnormal
99mTc-bone scan imaging must be confirmed by Computed Tomography (CT) Scan or
Magnetic resonance Imaging (MRI)

- Progressive disease following 1st line androgen deprivation therapy with LHRH
(luteinizing hormone-releasing hormone) Agonists or surgical castration.
Recommendations of Prostate Cancer Working Group 2 (PCWG2)

- WHO (World health organization) performance status ≤ 2

- Life expectancy > 12 weeks

- Adequate bone marrow function (Absolute neutrophil count (ANC) 1500/μL; platelets

- Castrate serum levels of testosterone (< 50 ng/dL)

- Adequate renal function: calculated creatinine clearance > 40 mL/minute

- Adequate hepatic function:

- Bilirubin: total bilirubin 1.5 Upper limit of Normal (ULN)

- Asparate aminotransferase (AST) and/or Alanine aminotransferase (ALT) ≤ 2.5 x
ULN in the absence of liver metastases or ≤ 5 x ULN if liver metastases are

- Patients of reproductive potential should use adequate birth control measures, as
defined by the investigator, during the study treatment period and for at least 4
months following the last study treatment. A highly effective method of birth control
is defined as those that result in low failure rate (i.e. less than 1% per year) when
used consistently and correctly

- Before patient registration/randomization, written informed consent must be given
according to ICH/GCP (International conference on Harmonization-Good Clinical
Practices), and national/local regulations

Exclusion criteria

- Cardiac function:

- Screening calculated ejection fraction (Multi Gated Acquisition Scan (MUGA)
scan, or by echocardiogram) must be ≥ 50%

- No history of myocardial infarction, unstable symptomatic ischemic heart
disease, ongoing arrhythmias of Grade > 2 thromboembolic events (e.g., deep vein
thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any
other cardiac condition (e.g., pericardial effusion restrictive cardiomyopathy)
within 6 months prior to first dose of study drug

- Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed

- Absence of New York Heart Association Class III or IV heart failure

- Absence of Electrocardiogram (ECG) abnormalities of: Q-wave infarction, unless
identified 6 or more months prior to screening and QTc interval > 470 msec

- No uncontrolled hypertension despite appropriate medical therapy defined as
blood pressure >160/90 mmHg at 2 separate measurements no more than 60 minutes
apart during the Screening visit

- Prior radiotherapy but only for lymph nodes is allowed

- Prior or concomitant therapy:

- No intake of narcotic analgesia for bone pain

- No prior treatment with non-steroidal antiandrogens, within 6 months prior to

- No anticancer therapy or treatment with another investigational agent within the
last 4 weeks prior to randomization

- No prior therapy with TAK-700, ketoconazole, abiraterone, aminoglutethimide or

- Patients taking bisphosphonates or denosumab are eligible if they have received
a stable dose for 4 weeks or more prior to randomization. (These treatments may
then be continued on study)

- No known hypersensitivity to compounds related to TAK-700 or to TAK-700 excipients
(refer to Investigator's brochure)

- No known gastrointestinal (GI) disease or GI procedure that could interfere with the
GI absorption or tolerance of TAK-700, including difficulty swallowing tablets

- No prior history of adrenal insufficiency

- No prior history of malignancies other than prostate adenocarcinoma (except for basal
cell or squamous cell carcinoma of the skin), or the patient has been free of
malignancy for a period of 3 years prior to first dose of study drug

- No known active chronic hepatitis B or C, life-threatening illness unrelated to
cancer, or any serious medical or psychiatric illness that could, in the
investigator's opinion, potentially interfere with participation in this study

- No drug or alcohol abuse

- Absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule;
those conditions should be discussed with the patient before registration in the

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint of the trial is clinical progression free survival.

Outcome Description:

The primary endpoint of the trial is clinical progression free survival. In this protocol, it is defined according to the recommendations of the "Prostate-Cancer clinical trials Working Group 2" and referred to as the "PCWG2" for the setting "delay/prevent" progression.

Safety Issue:


Principal Investigator

Cora Sternberg

Investigator Role:

Principal Investigator

Investigator Affiliation:

San Camillo Forlanini Hospitals, Rome, Italy


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

September 2013

Completion Date:

January 2017

Related Keywords:

  • Prostate Cancer
  • metastatic
  • prostate cancer
  • Prostatic Neoplasms