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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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18 October 2021 |
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Main ID: |
EUCTR2008-002158-40-FR |
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Date of registration:
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26/08/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OF SUNITINIB PLUS PREDNISONE VERSUS PREDNISONE IN PATIENTS WITH PROGRESSIVE METASTATIC HORMONE-REFRACTORY PROSTATE CANCER AFTER FAILURE OF A DOCETAXEL-BASED CHEMOTHERAPY REGIMEN
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Scientific title:
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A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OF SUNITINIB PLUS PREDNISONE VERSUS PREDNISONE IN PATIENTS WITH PROGRESSIVE METASTATIC HORMONE-REFRACTORY PROSTATE CANCER AFTER FAILURE OF A DOCETAXEL-BASED CHEMOTHERAPY REGIMEN |
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Date of first enrolment:
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21/08/2008 |
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Target sample size:
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819 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002158-40 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Czech Republic
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Denmark
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Finland
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France
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Germany
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Italy
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Portugal
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Slovakia
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Spain
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Sweden
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Histologically- or cytologically-confirmed adenocarcinoma of the prostate.
2. Metastatic hormone-refractory prostate cancer (refractory to androgen ablation). Patients must have surgical or ongoing chemical castration, with baseline testosterone level <50 ng/dL.
3. Patients must have disease that has failed one prior docetaxel-based chemotherapy regimen for the treatment of metastatic disease, defined as progression of disease on or after treatment (docetaxel-resistant), or be considered docetaxel-intolerant (discontinued treatment due to unacceptable toxicity, as judged by the treating physician or by the patient). In the event both disease progression and drug intolerance are observed during prior docetaxel-based treatment, disease progression will be considered the dominant entry criterion.
4. Patients must have documented evidence of progressive disease defined by either:
• PSA progression: minimum of 2 rising values (3 measurements) obtained a minimum
of one week apart with the last result being at least 2.0 ng/mL,
• RECIST, or
• Positive bone scan with 2 or more new lesions.
5. ECOG performance status 0 or 1.
6. Resolution of all acute toxic effects of prior therapy (except for alopecia and neuropathy) or surgical procedure to grade =1 or to baseline prior to therapy.
7. Adequate organ function as defined by the following criteria:
• Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) =2.5 x upper limit of normal (ULN), =5 x ULN for patients with liver metastases
• Total serum bilirubin =1.5 x ULN
• Absolute neutrophil count (ANC) =1500/µL
• Platelets =100,000/µL
• Hemoglobin =9.0 g/dL
• Serum creatinine =2 x ULN
• QTc interval =470 msec
• Left ventricular ejection fraction (LVEF) =lower limit of institutional normal (LLN) as
assessed by multigated acquisition (MUGA) scan or echocardiogram
8. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
9. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including the completion of patient reported outcomes questionnaires and an analgesic use diary.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Prior treatment with sunitinib (in any clinical setting) and/or more than one prior
chemotherapy regimen in the metastatic disease treatment setting.
2. Chemotherapy within 3 weeks of study entry.
3. Radioisotope therapy with Strontium-89 or Samarium within 12 weeks prior to study entry.
4. Radiation therapy (including palliative radiotherapy to metastatic lesion(s)) within 2 weeks or major surgery (e.g., open abdominal, pelvic, thoracic, orthopedic or neurosurgery) within 4 weeks prior to study entry.
5. Current treatment on another therapeutic clinical trial.
6. Impending complication from bone metastasis (fracture and/or cord compression).
7. Presence of ongoing urinary obstruction (e.g., urinary retention, hydronephrosis) requiring medical intervention. Properly treated urinary obstruction is allowed.
8. Grade =3 hemorrhage within 4 weeks prior to study entry.
9. Ongoing cardiac dysrhythmias of grade =2.
10. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
11. Ongoing treatment with therapeutic doses (with therapeutic INR levels) of coumarinderivatives or oral anti-vitamin K agents.
12. Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, stage I carcinoma fully treated, or in situ carcinoma that have been adequately treated with no evidence of recurrent disease for 12 months.
13. Any of the following within the 6 months prior to study drug administration:
severe/unstable angina, myocardial infarction, symptomatic congestive heart failure,
pulmonary embolism, cerebrovascular accident, or transient ischemic attack.
14. Known or suspected brain metastases (skull metastases allowed), spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
15. Known human immunodeficiency virus (HIV) infection.
16. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator would make the patient inappropriate for entry into the trial
Age minimum:
Age maximum:
Gender:
Female: no
Male: yes
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Health Condition(s) or Problem(s) studied
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metastatic Hormone-Refractory Prostate Cancer (mHRPC) after failure of a docetaxel-based chemotherapy regimen
MedDRA version: 9.1
Level: LLT
Classification code 10062904
Term: Hormone-refractory prostate cancer
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Intervention(s)
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Trade Name: Sutent®
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: sunitinib
CAS Number: 341031-54-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Sutent®
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: sunitinib
CAS Number: 341031-54-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: sunitinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 37.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Sutent®
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: sunitinib
CAS Number: 341031-54-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Cortancyl®
Pharmaceutical Form: Tablet
INN or Proposed INN: prednisone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
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Primary Outcome(s)
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Primary end point(s): Overall survival (OS)
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Main Objective: To demonstrate superiority in the overall survival (OS) of patients with progressive
mHRPC treated with sunitinib plus prednisone (SP) versus placebo plus prednisone
(PP) after failure of a docetaxel-based chemotherapy regimen.
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Secondary Objective: To demonstrate superiority in the progression-free survival (PFS) of patients with
progressive mHRPC treated with SP versus PP after failure of a docetaxel-based
chemotherapy regimen.
To compare the objective response rate (ORR) and duration of response (DR) in
patients with progressive mHRPC treated with SP versus PP after failure of a
docetaxel-based chemotherapy regimen.
To compare patient reported outcomes (PROs) of pain severity, health-related quality
of life, prostate cancer-specific symptoms, and general health status in patients with
progressive mHRPC treated with SP versus PP after failure of a docetaxel-based
chemotherapy regimen.
To evaluate the safety and tolerability of sunitinib in combination with prednisone.
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Secondary ID(s)
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2008-002158-40-ES
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A6181120
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 07/08/2008
Contact:
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