NCT00314782

Brief Summary

Two-part, multi-center study design to establish a maximum tolerated dose (MTD) of ZD4054 in combination with docetaxel and to explore its safety, tolerability, pharmacokinetic (PK) profiles and clinical efficacy in patients with metastatic hormone-refractory prostate cancer (HRPC)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1 prostate-cancer

Timeline
Completed

Started Mar 2006

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 13, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 12, 2013

Status Verified

March 1, 2010

Enrollment Period

2 years

First QC Date

April 13, 2006

Last Update Submit

March 11, 2013

Conditions

Prostate Cancer

Keywords

metastatic hormone-refractory prostate cancer (HRPC)

Outcome Measures

Primary Outcomes (1)

  • Part A: Maximum Tolerated Dose (MTD)

    Part A: Cycle 1 ('Primary analysis' corresponding to data cut-off 5th March 2008)

Study Arms (4)

Part A

EXPERIMENTAL

Part A (dose-finding): ZD4054 (Zibotentan) 10 mg oral tablet once daily, with docetaxel 75mg/m\^2 intravenous infusion once per cycle

Drug: ZD4054 (Zibotentan)Drug: Docetaxel

Part A (ZD4054 (Zibotentan) 15 mg + docetaxel)

EXPERIMENTAL

Part A (dose-finding): ZD4054 (Zibotentan) 15 mg oral tablet once daily, with docetaxel 75mg/m\^2 intravenous infusion once per cycle

Drug: ZD4054 (Zibotentan)Drug: Docetaxel

Part B

EXPERIMENTAL

Part B (randomised, placebo-controlled): ZD4054 (Zibotentan) Maximum Tolerated Dose (MTD), 15mg, oral tablet once daily, with docetaxel 75mg/m\^2 intravenous infusion once per cycle

Drug: ZD4054 (Zibotentan)Drug: Docetaxel

Part B (placebo)

EXPERIMENTAL

Part B (randomised, placebo-controlled): Matching placebo oral tablet once daily, with docetaxel 75mg/m\^2 intravenous infusion once per cycle

Drug: DocetaxelDrug: Placebo

Interventions

ZD4054 (Zibotentan)DRUG

oral tablet

Also known as: Zibotentan
Part APart A (ZD4054 (Zibotentan) 15 mg + docetaxel)Part B
DocetaxelDRUG

intravenous infusion

Also known as: Taxotere®
Part APart A (ZD4054 (Zibotentan) 15 mg + docetaxel)Part BPart B (placebo)
PlaceboDRUG
Part B (placebo)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of informed consent
  • Histological or cytological confirmation of prostate cancer
  • Evidence of metastatic disease on CT scan, MRI, or bone scan
  • Surgically or continuously medically castrated with LHRH analogue
  • Progressive disease after most recent therapy
  • Disease progression by CT/MRI
  • Bone scan progression: appearance of 1 or more new lesions since last bone scan
  • Rising PSA
  • World health organization (WHO) performance status 0 to 2
  • Life expectancy of 12 weeks or longer

You may not qualify if:

  • Use of anti-hormonal therapies (including ketoconazole, aminoglutethimide, finasteride and anti-androgen therapies) within 4 weeks of starting study treatment, except for bicalutamide and nilutamide which are excluded within 6 weeks of starting study treatment. Estramustine or estrogens, if taken, have to be stopped at least 4 weeks before starting treatment.
  • Definite or suspected personal history or family history of adverse drug reactions, or hypersensitivity to drugs that are endothelin antagonist; history of severe hypersensitivity reactions to drugs formulated with polysorbate 80.
  • Prior cytotoxic chemotherapy for metastatic prostate cancer
  • Radiotherapy within 4 weeks before the start of study therapy
  • Systemic radionuclide therapy (ie strontium chloride Sr89, 186Re-labeled HEDP, or 153Sm-EDTMP pentasodium) within 12 weeks before entering study
  • Use of potent CYP450 inhibitors (such as itraconazole, ritonavir, indinavir, erythromycin, troleandomycin, clarithromycin, diltiazem, verapamil) within 2 weeks before study entry.
  • Use of potent CYP450 inducers (such as phenytoin, rifampicin, carbamazepine and phenobarbitone, St. John's Wort) within 2 weeks before study entry.
  • New neurologic symptoms or signs consistent with acute or evolving spinal cord compression confirmed by magnetic resonance imaging (MRI) (except for those previously treated and have stable symptoms).
  • History of past or current epilepsy, epilepsy syndrome, or other seizure disorder
  • History of Migraine or chronic headache
  • Symptomatic central nervous system (CNS) metastases
  • Absolute Neutrophil Count (ANC) \<1.5 x 109/L (1,5000/mm3)
  • Platelet count \< 100 x 109/L (100,000/mm3)
  • Serum bilirubin greater than the upper limit of normal (ULN)
  • Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 1.5 times the upper limit of normal (ULN)
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Research Site

Buffalo, New York, United States

Location

Research Site

Greenville, South Carolina, United States

Location

Research Site

Nashville, Tennessee, United States

Location

Research Site

Berlin, Germany

Location

Research Site

Dresden, Germany

Location

Research Site

Rostock, Germany

Location

Research Site

London, United Kingdom

Location

Research Site

Plymouth, United Kingdom

Location

Research Site

Surrey, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

ZD4054Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • AstraZeneca Emerging Oncology Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2006

First Posted

April 17, 2006

Study Start

March 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2009

Last Updated

March 12, 2013

Record last verified: 2010-03

Locations

US(3)DE(3)GB(3)