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A Phase II Trial of AZD0530 in Hormone Refractory Prostate Cancer (HRPC)

Phase 2
18 Years
Not Enrolling
Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer

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Trial Information

A Phase II Trial of AZD0530 in Hormone Refractory Prostate Cancer (HRPC)


I. To test the hypothesis that AZD0530 will improve the prostate-specific antigen (PSA)
response rate and progression-free survival (PFS) in comparison with historical controls for
patients with hormone-refractory prostate cancer (HRPC).

II. Evaluate the time to treatment failure and overall survival of patients with HRPC
treated with AZD0530.

III. Evaluate the toxicities and tolerance of AZD0530 therapy in the HRPC population.

OUTLINE: This is a multicenter study.

Patients receive oral AZD0530 once daily. Treatment repeats every 4 weeks for up to 2
courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months for the first 2
years and then yearly thereafter.

Inclusion Criteria:

- Histologically or cytologically confirmed prostate cancer with a Gleason score
available or interpretable and meeting 1 of the following criteria:

- No prior chemotherapy and relatively minimal cancer spread

- Only one prior taxane-based chemotherapy for aggressive and/or symptomatic

- Must have prostate cancer considered to be hormone refractory or androgen independent
by one or more of the following criteria (despite androgen deprivation and
anti-androgen withdrawal when applicable):

- Progression of unidimensionally measurable disease assessed within 28 days prior
to initial administration of drug

- Progression of evaluable but not measurable disease assessed within 28 days
prior to initial administration of drug for PSA evaluation and within 42 days
for imaging studies (e.g., bone scans)

- Patients must have nonmeasurable disease (e.g., nuclear medicine bone scans) and
non-target lesions (e.g., PSA level) assessed within 28 days prior to initial
administration of drug

- Measurable disease is not required but is allowed

- Must be surgically or medically castrated

- If the method of castration was luteinizing hormone-releasing hormone (LHRH)
agonists (e.g., leuprolide or goserelin), then the patient must be willing to
continue the use of LHRH agonists

- Serum testosterone must be at castrate levels (< 50 ng/dL) at least 3 months
prior to registration

- ECOG performance status 0-2

- WBC >= 3,000/uL

- Absolute neutrophil count >= 1,500/uL

- Platelets >= 100,000/uL

- Hemoglobin > 9 g/d

- Total bilirubin within normal institutional limits

- AST/ALT =< 2.5 x institutional upper limit of normal

- Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min

- Must agree to use adequate contraception prior to study entry and for the duration of
study participation

- At least 3 weeks since the completion of chemotherapy and radiotherapy and the
patient must have recovered from the side effects of the therapy

- At least 28 days since prior non-steroidal anti-androgens (e.g., flutamide) (42 days
for bicalutamide or nilutamide) or hormonal treatment (e.g., ketoconazole) and
demonstrated progression of disease since the agents were suspended

- Concurrent bisphosphonate therapy is allowed

Exclusion Criteria:

- Known brain metastases

- History of allergic reactions attributed to compounds of similar chemical or
biological composition to AZD0530

- Patients with any of the following conditions that impair the ability to swallow
AZD0530 tablets

- Gastrointestinal tract disease resulting in an inability to take oral medication
or requiring IV alimentation

- Prior surgical procedures affecting absorption

- Active peptic ulcer disease

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection or psychiatric illness/social situations that would limit compliance with
study requirements

- Patients who have not recovered from adverse events due to agents administered more
than 4 weeks earlier

- Use of specifically prohibited CYP3A4-active agents or substances

- Prohibited drugs should be discontinued 7 days prior to the administration of
the first dose of AZD0530 and for 7 days following discontinuation of AZD0530

- Patients receiving any other investigational agents

- No investigational or commercial agents or therapies other than study drugs may be
administered with the intent to treat the patient's malignancy

- HIV-positive patients on combination antiretroviral therapy

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Time Frame:

Up to 2 years and annually thereafter

Safety Issue:


Principal Investigator

Primo Lara

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

Related Keywords:

  • Hormone-resistant Prostate Cancer
  • Recurrent Prostate Cancer
  • Prostatic Neoplasms



City of Hope Duarte, California  91010