COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

A Safety Study of ZD4054 in Prior Chemotherapy Treated Patients With Metastatic Hormone-resistant Prostate Cancer (DAPROCA-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01000948
Recruitment Status : Terminated (A consequence of the results of the ENTHUSE phase III study program)
First Posted : October 23, 2009
Last Update Posted : January 8, 2014
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Michael Borre, Aarhus University Hospital

Brief Summary:
This is a prospective, open, one-arm, two-centre, Phase II clinical safety pilot-study. The trial is designed to gain initial safety and efficacy-related data on once-daily orally administered ZD4054 10 mg in prior chemotherapy treated patients with metastatic hormone-resistant prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Metastasis Drug: ZD4054 Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Phase II, Two-centre, 1-Arm Safety Study of Once-daily Orally Administered 10 mg ZD4054 in Prior Chemotherapy Treated Patients With Metastatic Hormone-resistant Prostate Cancer
Study Start Date : October 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ZD4054
The study had only one arm: intervention
Drug: ZD4054
ZD4054 10 mg given orally, once daily in tablet form to all patients in two years or until investigator consider the drug for useless.

Primary Outcome Measures :
  1. To assess the safety and tolerability profile of ZD4054 after treatment with chemotherapy [ Time Frame: 2 years ]
  2. Adverse events [ Time Frame: 2 years ]
  3. Vital signs [ Time Frame: 2 years ]
  4. Laboratory data [ Time Frame: 2 years ]
  5. ECGs [ Time Frame: 2 years ]
  6. Physical Exam [ Time Frame: 2 years ]
  7. Death from any cause [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To investigate the effect of ZD4054 on rate of rise of PSA [ Time Frame: 2 years ]
  2. To investigate the effect of ZD4054 on prostate cancer related pain [ Time Frame: 2 years ]
  3. To investigate the effect of ZD4054 on the plasma concentration of circulating tumour cells (CTC). [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  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 bone scans.
  5. Surgically castrated or continuously medically castrated with serum testosterone less than 2.4 nmol/L (70 ng/dL).
  6. Previously (not inside 8 weeks) treated with at least two times 75 mg/m2 docetaxel.
  7. Biochemical progression of prostate cancer after chemotherapy, documented while the patient is castrate:

    o Biochemical progression is defined as at least 2 stepwise increases (≥1ng/mL) 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.

  8. Life expectancy of 3 months or more.

Exclusion Criteria:

  1. 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
  2. Have received investigational drug in another clinical study of anticancer therapy, within 4 weeks of starting study treatment
  3. Hypersensitivity to endothelin antagonists
  4. 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
  5. History of past or current epilepsy, epilepsy syndrome, or other seizure disorder
  6. 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
  7. QT interval corrected for heart rate e.g., by Bazett's correction >470 msec
  8. In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g., 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
  9. Hemoglobin (Hb) <5 mmol/L. Concomitant use of erythropoietin or blood transfusions is allowed
  10. 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
  11. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 times the ULN or 5 times the ULN in the presence of liver metastasis
  12. Creatinine clearance of <50 mL/minute, determined using the Cockcroft-Gault equation or by 24-hour creatinine clearance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01000948

Layout table for location information
Dpt of Urology,Aarhus University Hospital
Aarhus, Denmark, 8200
Sponsors and Collaborators
Aarhus University Hospital
Rigshospitalet, Denmark
Layout table for investigator information
Study Chair: Michael Borre, MD Phd DMSc Dpt Urology Aarhus University Hospital - DAPROCA
Layout table for additonal information
Responsible Party: Michael Borre, Professor, DMSci, PhD, Aarhus University Hospital Identifier: NCT01000948    
Other Study ID Numbers: ISSIS40540005
First Posted: October 23, 2009    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: July 2011
Keywords provided by Michael Borre, Aarhus University Hospital:
Prostate cancer
Castration resistant
Chemotherapy resistant
Endothelial receptor A inhibitor
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases