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TAK-700 in Castration Resistant Prostate Cancer

This study has been withdrawn prior to enrollment.
(Pharmaceutical company has terminated orteronel (TAK-700) development for Prostate Cancer)
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT01658527
First received: July 27, 2012
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

The objective of this randomized phase II open label trial is to determine the anti-tumor activity of TAK-700 (Orteronel) as compared to bicalutamide in terms of clinical progression-free survival in prostate cancer patients who failed 1st line treatment with LHRH (luteinizing hormone-releasing hormone) agonists or surgical castration.


Condition Intervention Phase
Prostate Cancer
Drug: Orteronel
Drug: Bicalutamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • The primary endpoint of the trial is clinical progression free survival. [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • RECIST (Response Evaluation Criteria In Solid Tumors) response in patients presenting with measurable disease [ Designated as safety issue: No ]
  • Time to PSA (Prostate specific antigen) progression and PSA change from baseline [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Safety according to Common Terminology Criteria for Adverse Events, version 4.03 [ Designated as safety issue: Yes ]
  • Pain (when an SAE (Serious Adverse Event)) or pain requiring initiation of narcotic analgesia [ Designated as safety issue: No ]
  • Skeletal related events, including requirement to initiate chemotherapy, radiotherapy, cord compression or requirement for surgery to the bone [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Orteronel, 300 mg twice daily Drug: Orteronel

Tak-700 will be administered until disease progression, diagnosis of a second malignancy, patient refusal to continue the treatment, excessive toxicity precluding further therapy according to protocol and /or according to the responsible physician.

Upon progression, patient may stay on study medication until the initiation of a new therapy

Other Name: TAK 700
Active Comparator: Bicalutamide 50 mg per day Drug: Bicalutamide
Bicalutamide will be given at the standard daily dose of 50 mg PO (per os). Bicalutamide will be maintained until disease progression diagnosis of a second malignancy, patient refusal to continue the treatment, excessive toxicity precluding further therapy according to protocol and /or according to the responsible physician.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 100,000/μL)
  • 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 present
  • 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 randomization
    • 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 MDV3100
    • 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 trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658527

Locations
Belgium
Onze Lieve Vrouw Ziekenhuis
Aals, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
AZ Groeninge Kortrijk - Campus Vercruysselaan
Kortrijck, Belgium
CHU Dinant Godinne - UCL Namur
Yvoir, Belgium
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Principal Investigator: Cora Sternberg San Camillo Forlanini Hospitals, Rome, Italy
Study Chair: Bertrand Tombal Cliniques Universitaires de St Luc, Brussels, Belgium
  More Information

No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01658527     History of Changes
Other Study ID Numbers: EORTC-1211, 2012-002122-67
Study First Received: July 27, 2012
Last Updated: June 30, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Research Ethics Committee

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
metastatic
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Bicalutamide
Androgen Antagonists
Antineoplastic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014