Assessment of the effects of the specific endothelin-A antagonist ZD4054 on prostate cancer biomarkers in patients with castrate-resistant metastatic disease - ZD4054 in metastatic prostate cancer

Phase 1

• Conditions: Prostate cancer; MedDRA version: 9.1 Level: LLT Classification code 10036909 Term: Prostate cancer metastatic

• Registration Number: EUCTR2008-002686-30-GB
• Lead Sponsor: Christie Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-27
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1.Histological confirmation of prostate adenocarcinoma.

2.Documented evidence of bone metastasis on radionuclide bone scan, MRI or plain radiograph

3.Biochemical progression of prostate cancer, documented while the patient is surgically or medically castrate:
-Biochemical progression is defined as at least 2 stepwise increases in PSA over a period of =1 month with at least 14 days between each measurement irrespective of assay or laboratory.
-The final PSA value must be =1.2ng/mL in patients who have had a radical prostatectomy and =1.5ng/mL in all other patients

4. Surgically or medically castrated with serum testosterone =2.4nmol/L (70ng/dL)

5. ECOG performance status 0 – 2.

6. 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)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Radiotherapy to bone lesion or prostatic bed within 4 weeks of starting study treatment.

2.Prior targeted cancer therapies (such as gefitinib, bevacizumab)

3.Systemic radionuclide therapy within 12 weeks of starting study treatment.

4.Current therapy, within 4 weeks of study entry with potent inhibitors on CYP3A4 (ketoconazole, itraconazole, ritinavir, indinavir, erythromycin, troleandomycin, clarithromycin, diltiazem and verapamil), inhibitors of CYPs 2D6 and 2C9 (quinidine and fluconazole), and potent P450 inducers (phenytoin, rifampicin, caramazepine and phenobarbitone).

5.Definite or suspected personal history or family history of adverse drug reactions, or hypersensitivity to drugs that are endothelin antagonists.

6.Ineligibility for MRI scanning includes standard MRI criteria (for example, metal implants such as cochlear implants, cardiac pacemakers, heart valves, aneurysm clips and metal fragments in eyes) and patients known to be allergic to gadolinium-based MRI contrast agents

7.In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease, or evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified