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Hormone-resistant Prostate CancerPhase 2NCT00513071

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

A Phase 2 study testing saracatinib and laboratory biomarker analysis in people with Hormone-resistant Prostate Cancer and Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
saracatinib and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
Aug 2007to Oct 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope

    Duarte, California, 91010

Other trials in United States

About this study

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

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
saracatinib, laboratory biomarker analysis
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • saracatinibDrug

    Also called AZD0530

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00513071
Study groupRoleWhat they receive
Treatment (saracatinib)ExperimentalPatients receive oral AZD0530 once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: saracatinib; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PSA Response Rate

    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

    Measured: PSA measured every 4 weeks

Secondary outcomes (6)

  1. Progression-free Survival (PFS)

    PFS defined as time between start of treatment and disease progression or death. Using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: From start of treatment until progression or death, up to 2 years

  2. Time to Treatment Failure

    Defined as the time from start of treatment to the discontinuation of treatment for any reason, including disease progression, treatment toxicity, patient preference, or death Will be summarized using the Kaplan-Meier product-limit estimators. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: From first day of treatment until discontinuation of treatment, up to 2 years

  3. Overall Survival

    Estimated using the product-limit method of Kaplan and Meier.

    Measured: From start of treatment, up to 5 years

  4. Toxicity Data

    Toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. All grade 3 or worse toxicities (Possibly, Probably, or Definitely) attributed to AZD0530.

    Measured: Up to 2 years

  5. Relationship Between Changes in Laboratory Correlates and Response and Survival

    Measured: Up to 2 years

  6. N-telopeptide and Deoxypyridinoline as Prognostic Bone Markers

    Measured: At baseline, at 6 hours, at each course (day 1), and at 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionOct 2008
  4. Study completionOct 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00513071
Sponsor's protocol ID
NCI-2012-02842
Other IDs
PHII-79, N01CM62209, N01CM62201, CDR0000559142
Status last verified
Mar 2018
First submitted
6 Aug 2007
Last updated
19 Apr 2018

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing saracatinib and laboratory biomarker analysis in people with Hormone-resistant Prostate Cancer and Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PSA Response Rate (time frame: PSA measured every 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00513071.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.

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