AZD0530 in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00513071
First received: August 6, 2007
Last updated: October 1, 2014
Last verified: December 2012
  Purpose

This phase II trial is studying how well AZD0530 works in treating patients with prostate cancer that did not respond to hormone therapy. AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth


Condition Intervention Phase
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Drug: saracatinib
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of AZD0530 in Hormone Refractory Prostate Cancer (HRPC)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • PSA Response Rate [ Time Frame: PSA measured every 4 weeks ] [ Designated as safety issue: No ]
    Complete Response (CR), disappearance of all measurable and non-measurable disease. No new lesions. PSA ≤ 0.2 ng/mL; Partial Response (PR), a decline in PSA by at least 30%, confirmed by a second PSA value four or more weeks later; Overall Response (OR) = CR + PR


Secondary Outcome Measures:
  • Progression-free Survival (PFS) According to RECIST [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    PFS defined as time between registration and disease progression or death. Using the method of Kaplan-Meier.

  • Time to Treatment Failure [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
  • Relationship Between Changes in Laboratory Correlates and Response and Survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • N-telopeptide and Deoxypyridinoline as Prognostic Bone Markers [ Time Frame: At baseline, at 6 hours, at each course (day 1), and at 2 years ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: August 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (saracatinib)
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.
Drug: saracatinib
Given orally
Other Name: AZD0530
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 disease
  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513071

Locations
United States, California
City of Hope
Duarte, California, United States, 91010
Sponsors and Collaborators
Investigators
Principal Investigator: Primo Lara Beckman Research Institute
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00513071     History of Changes
Other Study ID Numbers: NCI-2012-02842, PHII-79, N01CM62209, N01CM62201, CDR0000559142
Study First Received: August 6, 2007
Results First Received: July 30, 2014
Last Updated: October 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Saracatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014