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Hormone-resistant Prostate CancerPhase 2NCT01267266

Saracatinib in Treating Patients With Prostate Cancer

A Phase 2 study testing saracatinib in people with Hormone-resistant Prostate Cancer and Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 15 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This randomized phase II clinical trial is studying how well saracatinib works in treating patients with prostate cancer. Saracatinib 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?
Any age, men only
What is being tested?
saracatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
15 sitesUnited States
Study dates
Dec 2010to Nov 2013
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 Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed prostate cancer with progressive disease; progressive disease may be defined as either
  • New clinical or radiographic metastases
  • Rising PSA: PSA must be greater than 1.0 ng/mL with at least 2 consecutive rises after completion of prior therapy; the PSA values documenting these rises should be separated by no less than 10 days; the baseline PSA value may be taken from the end of prior therapy
  • Previous treatment with docetaxel for disease progression following hormonal therapy (i.e., castrate-resistant disease) required
  • Treatment in the adjuvant or neoadjuvant setting will NOT be grounds for inclusion unless docetaxel has been used again in the setting of progressive CRPC
  • ECOG performance status 0-1
Show all 34Show fewer
  • ANC ≥ 1,500/mm³
  • Hemoglobin > 9.0 g/dL
  • Platelet count > 100,000/mm³
  • Total bilirubin < 2.0 x institutional ULN
  • AST/ALT < 5 x institutional ULN in the presence of bone/liver metastases
  • Serum creatinine (Cr) within ULN
  • Patients with Cr > ULN must have a Cr clearance of > 60 mL/min
  • Testosterone 50 ng/mL or lower if a patient is receiving an LHRH agonist
  • No testosterone testing is required for men who have undergone surgical orchiectomy
  • Fertile patients must agree to abstinence or some adequate form of contraception
  • No patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs the ability to swallow AZD0530 tablets
  • No history of uncontrolled or unstable cardiac dysrhythmia
  • No resting ECG with measurable QTc interval of > 480 msec at 2 or more time points within a 24-hour period
  • No evidence of interstitial lung disease (bilateral, diffuse, parenchymal lung disease)
  • A high-resolution CT of the chest will be required during screening
  • No evidence of severe or uncontrolled systemic conditions (e.g., severe hepatic impairment) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
  • No patients with a known immunodeficiency syndrome
  • No patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD0530
  • No patients receiving any other investigational agents
  • Previous AZD0530 exposure is allowed provided that the patient did not show radiographic progression during treatment
  • Patients receiving non-steroidal anti-androgens (e.g., flutamide) or other hormonal treatment (such as ketoconazole, abiraterone, or TAK-700) must have stopped these drugs at least 28 days prior to enrollment for flutamide or ketoconazole, or at least 42 days prior to enrollment for bicalutamide or nilutamide, and the patients must have demonstrated progression of disease since the agents were suspended
  • Patients should be at least 2 weeks away from previous chemotherapy, surgery, or radiotherapy
  • No unresolved toxicity from previous treatments that are CTCAE grade 2 from previous anti-cancer therapy (except alopecia)
  • Patients who are currently on zoledronic acid (Zometa) or other bisphosphonate therapy are eligible provided that they have been on therapy at least 6 weeks prior to participation
  • Increases in bisphosphonate dosing will not be allowed (i.e., starting within 6 weeks or changing from every 3-month to every 1-month dosing)
  • Use of specifically prohibited CYP3A4-active agents or substances are not permitted during protocol treatment, and patients who must continue treatment with these agents are not eligible
  • 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 (unless otherwise specified)
  • No concurrent use of non-FDA approved medications

Who cannot join

None listed.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201-1595

  • University of Chicago

    Chicago, Illinois, 60637

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Fort Wayne Medical Oncology and Hematology Inc-Parkview

    Fort Wayne, Indiana, 46845

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • University of Wisconsin Women's Health Center

    Madison, Wisconsin, 53715

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Central Illinois Hematology Oncology Center

    Springfield, Illinois, 60702

  • Southern Illinois University

    Springfield, Illinois, 62702

  • Saint John's Mercy Medical Center

    St Louis, Missouri, 63141

Other trials in United States

About this study

Official title: A Randomized Discontinuation Phase 2 Study of AZD0530 as a Metastasis Inhibitor in Castrate Resistant Prostate Cancer

This randomized phase II clinical trial is studying how well saracatinib works in treating patients with prostate cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine if AZD0530 (saracatinib) increases time to radiographic progression in men with CRPC compared to placebo.

SECONDARY OBJECTIVES:

  1. Describe the adverse events related to AZD0530 in this population. II. Explore the role of FYN and other SRC kinase expression as a predictor of response to AZD0530.

OUTLINE: This is a multicenter study.

LEAD-IN PHASE: Patients receive oral saracatinib once daily during for 8 weeks. Patients who achieve disease regression or a PSA decrease of > 50% continue to receive open-label saracatinib. Patients who do not show radiographic evidence of new metastases on bone scan and CT, disease regression, or a > 50% decrease in PSA continue on to the randomized phase.

RANDOMIZED PHASE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive oral placebo once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Upon progression, patients may crossover to arm I.

Tissue samples may be collected for correlative studies. After completion of study treatment, patients are followed up for 12 months.

Being tested
saracatinib, hydrocortisone/placebo
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

  • hydrocortisone/placeboOther

    Given orally

Study groups in NCT01267266
Study groupRoleWhat they receive
Arm I (saracatinib)ExperimentalPatients receive oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: saracatinib
Arm II (placebo)Placebo comparatorPatients receive oral placebo once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Upon progression, patients may crossover to arm I.
Receives: Other: hydrocortisone/placebo

What is being measured

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

  1. Duration of Stable Disease. (Time to Disease Progression by CT and/or Bone Scan or Clinical Progression.)

    Time to progression will be assessed using the Kaplan-Meier method and compared between groups via Wilcoxon rank-sum test.

    Measured: Up to 6 months.

Secondary outcomes (3)

  1. Toxicity and Incidence of Adverse Events

    Percentage of patients with grade 4 toxicity.

    Measured: Up to 6 months.

  2. Toxicity and Incidence of Adverse Events.

    Percentage of patients who discontinued therapy due to toxicity.

    Measured: Up to 6 months.

  3. Correlation of Molecular Profile With Clinical Outcomes

    Study terminated after randomization of only 8 subjects. Correlative data not analyzed.

    Measured: Up to 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 posted28 Dec 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionSep 2012
  4. Study completionNov 2013

Why it stopped: Per protocol, study was terminated due to low rate of randomized patients.

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01267266
Sponsor's protocol ID
NCI-2011-02563
Other IDs
NCI-2011-02563, CDR0000691725, 10-436-B, 8446, N01CM00099, N01CM00071, U01CA062491, P30CA014599
Status last verified
Jan 2013
First submitted
24 Dec 2010
Last updated
1 Apr 2015

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing saracatinib in people with Hormone-resistant Prostate Cancer and Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 15 sites 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 34 inclusion and 0 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: stopped early, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites 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. Some participants in this study may receive a placebo. 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 1 Apr 2015). 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?

Duration of Stable Disease. (Time to Disease Progression by CT and/or Bone Scan or Clinical Progression.) (time frame: Up to 6 months.). 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 NCT01267266.

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 1 Apr 2015.

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