Phase I Study of ZD4054 (Zibotentan) and Docetaxel in Patients With Metastatic HRPC

Part of paid clinical trials in Buffalo, New York.

Sponsor
AstraZeneca
Study ID
NCT00314782
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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)

Key Dates

Start date
Mar 31, 2006
Status verified
Mar 2010
Primary completion
Mar 31, 2008
Completion
Mar 31, 2009

Study Design

Enrollment
44 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A
    Part A (dose-finding): ZD4054 (Zibotentan) 10 mg oral tablet once daily, with docetaxel 75mg/m\^2 intravenous infusion once per cycle
  • Experimental: Part A (ZD4054 (Zibotentan) 15 mg + docetaxel)
    Part A (dose-finding): ZD4054 (Zibotentan) 15 mg oral tablet once daily, with docetaxel 75mg/m\^2 intravenous infusion once per cycle
  • Experimental: Part B
    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
  • Experimental: Part B (placebo)
    Part B (randomised, placebo-controlled): Matching placebo oral tablet once daily, with docetaxel 75mg/m\^2 intravenous infusion once per cycle

Primary Outcome Measure

Part A: Maximum Tolerated Dose (MTD) [ Time Frame: Part A: Cycle 1 ('Primary analysis' corresponding to data cut-off 5th March 2008) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Research SiteBuffaloNew York--
Research SiteGreenvilleSouth Carolina--
Research SiteNashvilleTennessee--

Find similar trials in Buffalo, NY

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Research Site· Buffalo, NYResearch Site· Greenville, SCResearch Site· Nashville, TN

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