TAK-700 in Castration Resistant Prostate Cancer

NCT01658527 | Withdrawn Phase 2 DMC

• 2 other identifiers: EORTC-1211-GUCG-IG2012-002122-67
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

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

Keywords

metastatic; prostate cancer

Outcome Measures

Primary Outcomes (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)

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

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

• Overall survival

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

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

Study Arms (2)

Orteronel, 300 mg twice daily

EXPERIMENTAL

Drug: Orteronel

Bicalutamide 50 mg per day

ACTIVE COMPARATOR

Drug: Bicalutamide

Interventions

Orteronel 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

Also known as: TAK 700

Orteronel, 300 mg twice daily

Bicalutamide 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.

Bicalutamide 50 mg per day

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (4)

Onze Lieve Vrouw Ziekenhuis

Aalst, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

AZ Groeninge Kortrijk - Campus Vercruysselaan

Kortrijck, Belgium

Location

CHU Dinant Godinne - UCL Namur

Yvoir, Belgium

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

orteronel; bicalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cora Sternberg

  San Camillo Forlanini Hospitals, Rome, Italy

  PRINCIPAL INVESTIGATOR

• Bertrand Tombal

  Cliniques Universitaires de St Luc, Brussels, Belgium

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: August 7, 2012
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: June 10, 2016

Record last verified: 2016-06

Locations

BE (4)