A Phase III, Randomised, Double-blind Study to Assess the Efficacy andSafety of 10 mg ZD4054 versus Placebo in Patients with Hormone-resistantProstate Cancer and Bone Metastasis who are Pain Free or MildlySymptomatic - ND
- Conditions
- Patients with Hormone-resistantProstate Cancer and Bone Metastasis who are Pain Free or MildlySymptomaticMedDRA version: 9.1Level: LLTClassification code 10036911Term: Prostate cancer recurrent
- Registration Number
- EUCTR2007-003227-20-IT
- Lead Sponsor
- ASTRAZENECA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 580
1. Provision of informed consent
2. Male, aged 18 years or older
3. Histological or cytological confirmation of adenocarcinoma of the prostate
4. Documented evidence of bone metastasis on radionuclide bone scan. Patients must
have disease involvement <75% of the spine, pelvis and ribs in the anteroposterior
(AP) or posteroanterior (PA) view. Patients with ≤3 lesions seen on bone scan will
require a CT scan, MRI or x-ray to confirm
5. Biochemical progression of prostate cancer, documented while the patient is
castrate:
− Biochemical progression is defined as at least 2 stepwise increases in PSA over
a period of ≥1 month (values do not need to be consecutive but 2 values that
have increased since the previous highest value are required) with at least
14 days between each measurement irrespective of assay or laboratory
− Historical values may be used
− The last PSA must be an increase of ≥50 % of the first PSA value of the
3 values or an absolute increase of ≥10 ng/mL over the initial PSA
− The final PSA value must be ≥1.2 ng/mL in patients who have had a radical
prostatectomy and ≥5 ng/mL in all other patients
6. Asymptomatic or mild pain from prostate cancer, defined as a score of ≤2 in the
worst pain item of the BPI
7. Surgically castrated or continuously medically castrated with serum testosterone
≤2.4 nmol/L (70 ng/dL)
8. World Health Organisation (WHO) performance status 0 - 1
9. Life expectancy of 6 months or more.
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
1. Radiotherapy to bone lesion or prostatic bed within 4 weeks of starting study
treatment
2. Current use (from the time that written informed consent is given) of any opiates,
with the exception of opiates taken PRN for pain not directly related to prostate
cancer
3. Prior cytotoxic chemotherapy (such as paclitaxel, docetaxel and mitoxantrone) for
the treatment of recurrent prostate cancer (prior estramustine therapy is allowed), as
well as other targeted cancer therapies (such as EGF, EGFR, VEGF and VEGFR)
4. Systemic radionuclide therapy (ie, strontium chloride Sr89, 186Relabeled HEDP, or
153Sm-EDTMP pentasodium) within 12 weeks of starting study treatment
5. Use of potent CYP450 inducers (such as phenytoin, rifampicin, carbamazepine,
phenobarbitone and St John?s Wort) within 2 weeks of starting study treatment.
Dexamethasone will be allowed if the investigator feels it is necessary but is
encouraged to use a different form of steroid treatment wherever possible
6. Use of systemic retinoids within 2 weeks of starting study treatment
7. Have received investigational drug in another clinical study of anticancer therapy,
within 4 weeks of starting study treatment
8. Prior therapy with endothelin receptor antagonists or family history of
hypersensitivity to endothelin antagonists
9. Neurological symptoms or signs consistent with acute or evolving spinal cord
compression. If a patient has neurologic symptoms, an MRI must be performed that demonstrates no impending or actual spinal cord compression. Stable, previously
treated patients are allowed
10. Symptomatic peripheral neuropathy of CTCAE grade 2 or higher
11. Known or suspected central nervous system metastases
12. History of past or current epilepsy, epilepsy syndrome, or other seizure disorder
13. Stage II, III or IV cardiac failure (classified according to New York Heart
Association (NYHA) classification) or myocardial infarction within 6 months prior
to study entry
14. QT interval corrected for heart rate eg, by Bazett?s correction >470 msec
15. Previous history or presence of another malignancy, other than prostate cancer or
treated squamous/basal cell carcinoma of the skin, within the last 5 years
16. In the opinion of the investigator, any evidence of severe or uncontrolled systemic
disease (eg, currently unstable or uncompensated respiratory, cardiac, hepatic or
renal disease) or evidence of any other significant clinical disorder or laboratory
finding that makes it undesirable for the patient to participate in the study
17. Hemoglobin (Hb) <9 g/dL. Concomitant use of erythropoietin or blood
transfusions is allowed
18. Serum bilirubin >1.5 times the upper limit of normal (ULN). This will not apply to
patients with Gilbert?s syndrome (persistent or recurrent hyperbilirubinemia that is
predominantly unconjugated in the absence of evidence of haemolysis or hepatic
pathology), who will be allowed in consultation with their physician
19. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 times
the ULN or 5 times the ULN in the presence of liver metastasis
20. Creatinine clearance of <50 mL/minute, determined using the Cockcroft-Gault
equation or by 24-hour creatinine clearance
21. ......
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method