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Prostate CancerPhase 2NCT01385293

BKM120 in Metastatic Castration-resistant Prostate Cancer

A Phase 2 study testing BKM120 in people with Prostate Cancer and Metastatic (Spread to Other Areas of the Body), run by Andrew J. Armstrong, MD at 3 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

The purpose of this study is to evaluate the effects of the study drug, BKM120. The study drug, BKM120, is an inhibitor of a protein called phosphatidyl inositol-3-kinase (PI3K). This protein is found in normal cells and in cancer cells, but often in many cancer cells this protein is overactive. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
BKM120
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesUnited States
Study dates
Aug 2011to Feb 2016
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

  • Age ≥ 18 years
  • Karnofsky performance status ≥ 70
  • Life expectancy of ≥ 12 weeks as determined by treating investigator
  • Adequate laboratory parameters
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate. Histologic variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate are permitted
  • Radiographic evidence of metastatic disease
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  • Evidence of disease progression on androgen deprivation therapy (ADT)
  • A minimum of 4 weeks elapsed off of antiandrogen therapy prior to registration (i.e. flutamide, nilutamide) and 6 weeks for bicalutamide, without evidence of an anti-androgen withdrawal response. Patients who did not have a PSA decline with the most recent antiandrogen therapy require only a 2 week washout period prior to registration
  • A minimum of 2 weeks from prior abiraterone acetate, sipuleucel-T, MDV3100, orteronel (TAK700), ketoconazole, or other experimental anti-cancer therapies prior to registration is required. Concomitant treatment with enzalutamide is permitted.
  • At least one prior systemic chemotherapy regimen FDA approved for metastatic prostate cancer
  • A minimum of 4 weeks from any major surgery prior to registration

Who cannot join

  • Have received prior treatment with a PI3K inhibitor
  • Known hypersensitivity to BKM120 or to its excipients
  • Untreated brain metastases
  • Patients with hepatitis B or C, other acute or chronic liver disease, or a recent (within 12 months of administration of first dose of study drug) history of pancreatitis
  • Patients with certain mood disorders as judged by the investigator or a psychiatrist
  • History of treatment in an inpatient psychiatric setting
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  • Concurrent severe and/or uncontrolled cardiac conditions which could compromise participation in the study
  • Other concurrent severe and/or uncontrolled concomitant medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol
  • Uncontrolled diabetes mellitus defined as a fasting plasma glucose level of >120.
  • Diarrhea ≥ CTCAE grade 2
  • Drugs or substances known to be strong inhibitors or inducers of the isoenzyme CYP3A4 should be avoided as systemic therapy in association with BKM120 as these can alter its metabolism. Topical use of creams or other applications not absorbed into the circulation is permitted
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • Have been treated with any granulocyte colony-stimulating growth factors (e.g., G-CSF, GM-CSF) ≤ 2 weeks prior to starting study drug. Erythropoietin or darbepoetin therapy, if initiated at least 2 weeks prior to enrollment, may be continued
  • Currently receiving treatment with medication that has the potential to significantly prolong the QT interval or induce Torsades de Pointes, and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug
  • Have received immunosuppressive therapy including corticosteroids ≤ 2 weeks prior to starting study drug. Prednisone at a total daily dose of 10 mg orally or its equivalent is permitted, if initiated at least 2 weeks prior to enrollment
  • History of solid organ or stem cell transplantation
  • Have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy prior to administration of first dose of study drug
  • Have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy prior to administration of first dose of study drug
  • Currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant
  • Known diagnosis of human immunodeficiency virus (HIV) infection
  • History of another malignancy within 3 years, except cured basal cell or squamous cell carcinoma of the skin or low grade papillary bladder cancer Other inclusion and exclusion criteria apply

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

  • University of Washington

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Phase II Study of BKM120 in Men With Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to evaluate the effects of the study drug, BKM120. The study drug, BKM120, is an inhibitor of a protein called phosphatidyl inositol-3-kinase (PI3K). This protein is found in normal cells and in cancer cells, but often in many cancer cells this protein is overactive. Inhibiting the protein may slow the growth of prostate cancer but this has not been tested yet in men with prostate cancer.

Read the detailed description

This is an open label, single arm phase II study of BKM120 in men with metastatic castration resistant prostate cancer (CRPC) who have progressed on or following completion of docetaxel-based chemotherapy. Prior progression on cabazitaxel, provenge, abiraterone, or enzalutamide (MDV3100) is also permitted. Patients must have baseline evaluations performed prior to the first dose of study drug and must meet all inclusion and exclusion criteria. Results of the baseline evaluations, which assure that all inclusion and exclusion criteria have been satisfied, must be reviewed by the Principal Investigator or his/her designee prior to enrollment of that patient. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent must be obtained from the patient prior to protocol-specific screening tests. The following criteria apply to all patients enrolled onto the study unless otherwise specified.

Being tested
BKM120
Keywords
BKM120, prostate cancer, metastatic castrate-resistant prostate cancer (mCRPC)
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

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

  • BKM120Drug

    Also called BKM-120

    BKM120 at the maximum tolerated dose (MTD) of 100mg orally daily

Study groups in NCT01385293
Study groupRoleWhat they receive
Study armExperimentalBKM120 at 100mg orally daily
Receives: Drug: BKM120

What is being measured

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

  1. Progression Free Survival (PFS) Prostate Cancer Working Group 2 (PCWG2) Criteria or Based on the Onset of a Skeletal Related Event.

    Time in months from the start of study treatment to the date of first progression or death due to any cause. Progression was determined either radiographically using a composite of the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Working Group 2 (PCWG2) criteria or clinically as judged from a skeletal-related event, need for change in therapy, or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.

    Response and progression are evaluated using a combination of Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and guidelines for prostate cancer endpoints developed by the Prostate Cancer Clinical Trials Working Group (PCWG2). Per RECIST, progression is defined 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: 5 years

Secondary outcomes (6)

  1. Radiologic Response

    The number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. Response and progression is evaluated using a combination of the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) and the guidelines for prostate cancer endpoints developed by the Prostate Cancer Clinical Trials Working Group (PCWG2). Per RECIST, progression is defined 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: 2 years

  2. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Number of patients experiencing grade 3-5 adverse events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

    Measured: Up to 28 days post last study drug dose. This is the follow-up safety visit.

  3. Prostate Specific Antigen (PSA) Response

    The number of patients with a 30% and 50% decrease in PSA from baseline.

    Measured: 2 years

  4. Overall Survival of Participants.

    Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.

    Measured: 5 years

  5. Change in Circulating Tumor Cell (CTC) Levels From Baseline

    The number of patients with a baseline CTC level of at least 5 who achieved a CTC level of less than 5 during the study.

    Measured: 2 years

  6. Time to New Metastatic Disease From the Baseline Visit

    Time in days from the start of study treatment to time of new metastatic disease. Time to new metastatic disease is, defined from the date of first study agent administration to the onset of a new evaluable site of disease as per PCWG2 and RECIST 1.1 guidelines, excluding the primary site and all sites documented at baseline will be assessed. Only those patients that experienced a new lesion per this definition are included.

    Measured: 5 years

Timeline

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

  1. First posted30 Jun 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Why it stopped: The trial was stopped at the first stage due to futility

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01385293
Sponsor's protocol ID
Pro00027410
Status last verified
Apr 2017
First submitted
28 Jun 2011
Last updated
19 May 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BKM120 in people with Prostate Cancer and Metastatic (Spread to Other Areas of the Body), run by Andrew J. Armstrong, MD at 3 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 11 inclusion and 21 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 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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. 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 7 Apr 2017). 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?

Progression Free Survival (PFS) Prostate Cancer Working Group 2 (PCWG2) Criteria or Based on the Onset of a Skeletal Related Event. (time frame: 5 years). 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 NCT01385293.

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 May 2017.

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