TAK-700 in Castration Resistant Prostate Cancer

NCT ID: NCT01658527

Last Updated: 2016-06-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-01-31

Brief 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 surgical castration.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Orteronel, 300 mg twice daily

Group Type: EXPERIMENTAL

Orteronel

Intervention Type: DRUG

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

Bicalutamide 50 mg per day

Group Type: ACTIVE_COMPARATOR

Bicalutamide

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

TAK 700

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cora Sternberg

Role: PRINCIPAL_INVESTIGATOR

San Camillo Forlanini Hospitals, Rome, Italy

Bertrand Tombal

Role: STUDY_CHAIR

Cliniques Universitaires de St Luc, Brussels, Belgium

Locations

Onze Lieve Vrouw Ziekenhuis

Aalst, , Belgium

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

AZ Groeninge Kortrijk - Campus Vercruysselaan

Kortrijck, , Belgium

CHU Dinant Godinne - UCL Namur

Yvoir, , Belgium

Countries

Belgium

Other Identifiers

2012-002122-67

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EORTC-1211-GUCG-IG

Identifier Type: -

Identifier Source: org_study_id