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Prostate CancerPhase 2NCT01658527

TAK-700 in Castration Resistant Prostate Cancer

A Phase 2 study testing Orteronel and Bicalutamide in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 4 sites in Belgium.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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… 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 Bicalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
4 sitesBelgium
Study dates
Jan 2014to Jan 2017
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

4 sites in 1 country.

Belgium4 sites

  • Onze Lieve Vrouw Ziekenhuis

    Aalst

  • Cliniques Universitaires Saint-Luc

    Brussels

  • AZ Groeninge Kortrijk - Campus Vercruysselaan

    Kortrijck

  • CHU Dinant Godinne - UCL Namur

    Yvoir

Other trials in Belgium

About this study

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.

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.

Conditions
Prostate Cancer
Being tested
Orteronel, Bicalutamide
Keywords
metastatic, prostate cancer
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

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

  • OrteronelDrug

    Also called TAK 700

    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

  • BicalutamideDrug

    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.

Study groups in NCT01658527
Study groupRoleWhat they receive
Orteronel, 300 mg twice dailyExperimentalNot described
Receives: Drug: Orteronel
Bicalutamide 50 mg per dayActive comparatorNot described
Receives: Drug: Bicalutamide

What is being measured

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

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

    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 outcomes (6)

  1. RECIST (Response Evaluation Criteria In Solid Tumors) response in patients presenting with measurable disease

  2. Time to PSA (Prostate specific antigen) progression and PSA change from baseline

  3. Overall survival

  4. Safety according to Common Terminology Criteria for Adverse Events, version 4.03

  5. Pain (when an SAE (Serious Adverse Event)) or pain requiring initiation of narcotic analgesia

  6. Skeletal related events, including requirement to initiate chemotherapy, radiotherapy, cord compression or requirement for surgery to the bone

Timeline

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

  1. First posted7 Aug 2012 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2016 (estimated)
  4. Study completionJan 2017 (estimated)

Why it stopped: Pharmaceutical company has terminated orteronel (TAK-700) development for Prostate Cancer

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01658527
Sponsor's protocol ID
EORTC-1211-GUCG-IG
Other IDs
2012-002122-67
Status last verified
Jun 2016
First submitted
27 Jul 2012
Last updated
10 Jun 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Orteronel and Bicalutamide in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 4 sites in Belgium.

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 13 inclusion and 21 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: withdrawn, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium. 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 phase mean?

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

The primary endpoint of the trial is clinical progression free survival.. 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 NCT01658527.

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 10 Jun 2016.

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