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

NCT01000948 | Terminated Phase 2 DMC

• 2 other identifiers: ISSIS40540005DAPROCA-1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Metastasis

Keywords

Prostate cancer; Castration resistant; Chemotherapy resistant; Endothelial receptor A inhibitor; ZD4054

Outcome Measures

Primary Outcomes (7)

• To assess the safety and tolerability profile of ZD4054 after treatment with chemotherapy

  2 years

• Adverse events

  2 years

• Vital signs

  2 years

• Laboratory data

  2 years

• ECGs

  2 years

• Physical Exam

  2 years

• Death from any cause

  2 years

Secondary Outcomes (3)

• To investigate the effect of ZD4054 on rate of rise of PSA

  2 years

• To investigate the effect of ZD4054 on prostate cancer related pain

  2 years

• To investigate the effect of ZD4054 on the plasma concentration of circulating tumour cells (CTC).

  2 years

Study Arms (1)

ZD4054

EXPERIMENTAL

The study had only one arm: intervention

Drug: ZD4054

Interventions

ZD4054 DRUG

ZD4054 10 mg given orally, once daily in tablet form to all patients in two years or until investigator consider the drug for useless.

ZD4054

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent
• Male, aged 18 years or older
• Histological or cytological confirmation of adenocarcinoma of the prostate
• Documented evidence of bone metastasis on bone scans.
• Surgically castrated or continuously medically castrated with serum testosterone less than 2.4 nmol/L (70 ng/dL).
• Previously (not inside 8 weeks) treated with at least two times 75 mg/m2 docetaxel.
• 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.
• Life expectancy of 3 months or more.

You may not qualify if:

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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Dpt of Urology,Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

ZD4054

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

• Michael Borre, MD Phd DMSc

  Dpt Urology Aarhus University Hospital - DAPROCA

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, DMSci, PhD

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 23, 2009
• Study Start: October 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 8, 2014

Record last verified: 2011-07

Locations

DK (1)