High Risk Prostate CancerPhase 2NCT01695473
Neoadjuvant BKM120 in High-risk Prostate Cancer
A Phase 2 study testing BKM120 in people with High Risk Prostate Cancer, run by Won Kim at 1 site in United States.
Trial summary
This is a phase II, study of BKM120 in patients with high-risk, localized prostate cancer. Eligible patients will be enrolled and scheduled to have an ultrasound-guided biopsy of the prostate to confirm high-risk disease and collect prostate tissue for analysis. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- High Risk Prostate Cancer
- 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
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2013to 5 Feb 2015
- 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 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate
- Candidate for radical prostatectomy
- Prostate cancer with the following pathological characteristics:
- Gleason sum > 8 AND at least 2 discrete core biopsies containing a minimum of 20% cancer or,
- Gleason pattern 4 + 3 = 7 and greater than 50% of biopsies positive for prostate cancer
- Age >= 18 years
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- Eastern Cooperative Oncology Group (ECOG) performance status > 2
- Ability to take oral medications (capsule must be swallowed with liquid)
- Adequate bone marrow function as shown by: Absolute Neutrophil Count (ANC) >= 1.5 x 109/liter, Platelets ≥ 100 x 109/L, Hemoglobin > 9 grams(g) /decilitre(dL)
- Total calcium (corrected for serum albumin) within normal limits (biphosphonate use for malignant hypercalcemia control is not allowed)
- Magnesium >= the lower limit of normal
- Potassium within normal limits for the institution
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within normal range
- Serum bilirubin within normal range (or total bilirubin <= 3.0 x upper limit of normal (ULN) with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)
- Serum creatinine <= 1.5 x upper limit of normal (ULN) or 24-hour clearance >= 50 milliliter per min (mL/min)
- Serum amylase <= ULN
- Serum lipase <= ULN
- Fasting plasma glucose <= 120 mg/dL (6.7 mmol/L)
- International Normalized Ratio (INR) <= 2
- Men of reproductive potential and their female partners must use highly effective contraception during treatment, for 5 half-lives (8 days) after stopping treatment and for additional 12 weeks (3 months in total after study drug discontinuation) and should not father a child in this period The highly effective contraception is defined as either:
- True abstinence: When this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Sterilization: Female partners have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- Male participant sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
- Use of a combination of any two of the following (a+b):
- Female partner with prior placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository • Oral contraception use by female partners, injected or implanted hormonal methods are not allowed as BKM120 potentially decreases the effectiveness of hormonal contraceptives.
- Fertile males, defined as all males physiologically capable of conceiving offspring must use condom during treatment, for 5 half-lives (8 days) after stopping treatment and for additional 12 weeks (3 months in total after study drug discontinuation) and should not father a child in this period.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Prior treatment with a phosphatidylinositol 3-kinase (PI3K) inhibitor
- Known hypersensitivity to BKM120 or to its excipients
- History of another malignancy within 3 years, except cured basal cell carcinoma of the skin
- Hormonal therapy with Gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists or high dose bicalutamide within 1 month of enrollment unless serum testosterone is within normal limits.
- Following mood disorders as judged by the investigator and/or symptom management service co-investigator, or as a result of patient's mood assessment questionnaire:
- Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)
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- Current >= NCI Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety
- Meets the cut-off score of >= 10 in the Patient Health Questionnaire (PHQ-9) or a cut-off of >= 15 in the Generalized Anxiety Disorder (GAD-7) mood scale, respectively, or selects a positive response of "1, 2, or 3" to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9) will be excluded from the study
- Current diarrhea >= CTCAE grade 2
- Active cardiac disease including any of the following:
- History of left ventricular ejection fraction (LVEF) < 50% as determined by Multiple Grated acquisition (MUGA) scan or echocardiogram (ECHO)
- QTc > 450 msec on screening electrocardiogram (ECG (using the QTcF formula)
- Angina pectoris that requires the use of anti-anginal medication
- History of ventricular arrhythmias except for benign premature ventricular contractions
- Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication
- Conduction abnormality requiring a pacemaker
- Valvular disease with documented compromise in cardiac function
- Symptomatic pericarditis
- History of cardiac dysfunction including any of the following:
- Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function
- History of documented congestive heart failure (New York Heart Association functional classification III-IV)
- Documented cardiomyopathy
- Poorly controlled diabetes mellitus or active, steroid-induced diabetes mellitus
- Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
- 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). Patients with unresolved diarrhea will be excluded as previously indicated
- Treatment with any hematopoietic colony-stimulating growth factors (G-CSF or 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
- Current treatment with medication with a known risk to prolong the QT interval or inducing Torsades de Pointes and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug. Please refer to section 10.2 for a list of prohibited QT prolonging drugs with risk of Torsades de Pointes.
- Current, chronic treatment with steroids or another immunosuppressive agent
- Note: Topical applications (e.g. rash), inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intr-articular) are allowed. If a patient stops corticosteroids prior to study participation, a 2-week washout is required.
- Taking herbal medications and certain fruits and juices within 7 days prior to starting study drug. Herbal medications include, but are not limited to St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng. Fruits and juice include the Cytochrome P450 3A (CYP3A) inhibitors: Seville oranges, grapefruit, and pomelos.
- Current treatment with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug. Please refer to Section 10.2 for a list of prohibited inhibitors and inducers of CYP3A (Please note that co-treatment with weak inhibitors of CYP3A is allowed)
- Chemotherapy or targeted anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug
- Any continuous or intermittent small molecule therapeutics (excluding monoclonal antibodies) <= 5 effective half lives prior to starting study drug or patients who have not recovered from side effects of such therapy 19 Major surgery <= 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
- 20. Current treatment with warfarin sodium or any other coumadin-derivative anticoagulant 21. Known diagnosis of human immunodeficiency virus (HIV) infection. Testing is not required for participation.
- 22. Unable or unwilling to abide by the study protocol or cooperate fully with the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: A Pharmacodynamic Study of Pre-prostatectomy BKM120 in Men With High-risk, Localized Prostate Cancer
This is a phase II, study of BKM120 in patients with high-risk, localized prostate cancer. Eligible patients will be enrolled and scheduled to have an ultrasound-guided biopsy of the prostate to confirm high-risk disease and collect prostate tissue for analysis. Two weeks after the biopsy, patients will begin taking 100 mg/day of BKM120. BKM120 will be given at this dose level orally once daily for 14 days prior to radical prostatectomy at University of California, San Francisco. Radical prostatectomy will be performed on the day of the last dose of BKM120 at day 14. No further drug will be tken after the radical prostatectomy.
Read the detailed description
This is a phase II, prospective, pharmacodynamic study of BKM120 in high-risk, localized prostate cancer. After informed consent and central pathology review of the core prostate biopsy, eligible patients will be enrolled and scheduled to have an ultrasound-guided biopsy of the prostate to confirm high-risk disease and collect tissue for molecular analysis. Two weeks after the biopsy, patients will begin taking 100 mg/day of BKM120. BKM120 will be given at this dose level orally once daily for 14 days prior to radical prostatectomy at University of California, San Francisco. Radical prostatectomy will be performed on the day of the last dose of BKM120 at day 14. No further drug will be administered after radical prostatectomy.
Up to 24 patients, or 21 evaluable patients, will be enrolled through the Department of Urology or Genitourinary Medical Oncology at the University of California, San Francisco for this pharmacodynamic study. Toxicity will be assessed during BKM120 administration, and will involve a clinic visit on Day 14 ± 2 (i.e. before surgery). Follow-up with safety evaluations will be at 90 ± 7 days post-operatively and involve a toxicity questionnaire, blood tests, and clinic visit. Toxicity will be monitored and reported using NCI Common Toxicity Criteria version 4.0 guidelines.
A patient symptom diary will be distributed to each patient at baseline for symptom self-recording and BKM120 dose self-administration. In addition, a patient identifier card (wallet-sized) will be distributed to each patient after informed consent and registration. This information will contain the patient's age, study name and number, investigator and study coordinator contact information, and expected adverse events that may be present as a result of BKM120 administration.
- Conditions
- High Risk Prostate Cancer
- Being tested
- BKM120
- Keywords
- Prostate cancer, High-risk prostate cancer, Radical prostatectomy, BKM120
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BKM120Drug
Also called Buparlisib
Two weeks after confirmatory biopsy, patients will begin taking 100 mg/day of BKM120. BKM120 will be given at this dose level orally once daily for 14 days prior to radical prostatectomy. Radical prostatectomy will be performed on the day of the last dose of BKM120 at day 14. No further drug will be administered after radical prostatectomy. For unforeseen delays in OR scheduling, up to 7 additional days of BKM120 may be administered prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant BKM120 | Experimental | Two weeks after confirmatory biopsy, patients will begin taking 100 mg/day of BKM120. BKM120 will be given at this dose level orally once daily for 14 days prior to radical prostatectomy. Radical prostatectomy will be performed on the day of the last dose of BKM120 at day 14. No further drug will be administered after radical prostatectomy. For unforeseen delays in operating room (OR) scheduling, up to 7 additional days of BKM120 may be administered prior to surgery. Receives: Drug: BKM120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Decrease in Phosphorylated S6 Immunohistochemistry (ICH) From Baseline
Percentage of men with downstream target inhibition of PI3K in prostate tumor tissue as measured by phosphorylated S6 immunohistochemistry (ICH) when treated with 100 mg/day of BKM120 using paired tumor biopsies from before and after drug administration and defined as ≥ 60% decrease in phosphorylated S6 (pS6) from baseline by Immunohistochemistry (IHC).
Measured: Up to 3 months
Secondary outcomes (3)
Percentage of Participants With Decrease in 4E-binding protein1 (p4EBP1) Protein Phosphorylation From Baseline
Percentage of men with downstream target inhibition of phosphatidylinositol 3-kinase (PI3K) in prostate tumor tissue as measured by 4E-binding protein1 (4EBP1) protein phosphorylation immunohistochemistry (IHC) using paired tumor biopsies from before and after drug administration and defined as >= 60% decline in p4EBP1 IHC
Measured: Up to 3 months
Percentage of Participants With Decrease in AKT Protein From Baseline
Proportion of men with downstream target inhibition of PI3K in prostate tumor tissue as measured by Protein kinase B (pAKT) IHC determined by a >= 60% decline in pAKT IHC
Measured: Up to 3 months
Number of Participants Displaying Activity of Short Term BKM120 Administration
Activity of short term BKM120 administration in prostate cancer was determined by measured PSA response immediately prior to radical prostatectomy
Measured: 1 Day, immediately prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study start23 Apr 2013
- Primary completion5 Feb 2015
- Study completion5 Feb 2015
Why it stopped: Lack of Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for High Risk Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Won Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor-investigator, Won Kim, University of California, San Francisco
- Investigators
- Won Kim, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695473
- Sponsor's protocol ID
- 115516
- Other IDs
- NCI-2013-01830
- Status last verified
- Jan 2021
- First submitted
- 26 Sep 2012
- Last updated
- 13 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacodynamic Study of Pre-prostatectomy BKM120 in Men With High-risk, Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT01695473
- Acronym / sponsor ID
- 115516
- Conditions
- High Risk Prostate Cancer
- Keywords
- Prostate cancer, High-risk prostate cancer, Radical prostatectomy, BKM120
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Won KimUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 23 Apr 2013 (actual)
- Primary completion
- 5 Feb 2015 (actual)
- Study completion
- 5 Feb 2015 (actual)
- First posted
- 28 Sep 2012 (estimated)
- Results
- Posted 13 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, study of BKM120 in patients with high-risk, localized prostate cancer. Eligible patients will be enrolled and scheduled to have an ultrasound-guided biopsy of the prostate to confirm high-risk disease and collect prostate tissue for analysis. Two weeks after the biopsy, patients will begin taking 100 mg/day of BKM120. BKM120 will be given at this dose level orally once daily for 14 days prior to radical prostatectomy at University of California, San Francisco. Radical prostatectomy will be performed on the day of the last dose of BKM120 at day 14. No further drug will be tken after the radical prostatectomy.
Detailed description
This is a phase II, prospective, pharmacodynamic study of BKM120 in high-risk, localized prostate cancer. After informed consent and central pathology review of the core prostate biopsy, eligible patients will be enrolled and scheduled to have an ultrasound-guided biopsy of the prostate to confirm high-risk disease and collect tissue for molecular analysis. Two weeks after the biopsy, patients will begin taking 100 mg/day of BKM120. BKM120 will be given at this dose level orally once daily for 14 days prior to radical prostatectomy at University of California, San Francisco. Radical prostatectomy will be performed on the day of the last dose of BKM120 at day 14. No further drug will be administered after radical prostatectomy.
Up to 24 patients, or 21 evaluable patients, will be enrolled through the Department of Urology or Genitourinary Medical Oncology at the University of California, San Francisco for this pharmacodynamic study. Toxicity will be assessed during BKM120 administration, and will involve a clinic visit on Day 14 ± 2 (i.e. before surgery). Follow-up with safety evaluations will be at 90 ± 7 days post-operatively and involve a toxicity questionnaire, blood tests, and clinic visit. Toxicity will be monitored and reported using NCI Common Toxicity Criteria version 4.0 guidelines.
A patient symptom diary will be distributed to each patient at baseline for symptom self-recording and BKM120 dose self-administration. In addition, a patient identifier card (wallet-sized) will be distributed to each patient after informed consent and registration. This information will contain the patient's age, study name and number, investigator and study coordinator contact information, and expected adverse events that may be present as a result of BKM120 administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant BKM120 | Experimental | Drug: BKM120Two weeks after confirmatory biopsy, patients will begin taking 100 mg/day of BKM120. BKM120 will be given at this dose level orally once daily for 14 days prior to radical prostatectomy. Radical prostatectomy will be performed on the day of the last dose of BKM120 at day 14. No further drug will be administered after radical prostatectomy. For unforeseen delays in operating room (OR) scheduling, up to 7 additional days of BKM120 may be administered prior to surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Histologically confirmed adenocarcinoma of the prostate
- Candidate for radical prostatectomy
- Prostate cancer with the following pathological characteristics:
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status > 2
Key exclusion criteria (35 listed)
- Prior treatment with a phosphatidylinositol 3-kinase (PI3K) inhibitor
- Known hypersensitivity to BKM120 or to its excipients
- History of another malignancy within 3 years, except cured basal cell carcinoma of the skin
- Hormonal therapy with Gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists or high dose bicalutamide within 1 month of enrollment unless serum testosterone is within normal limits.
- Following mood disorders as judged by the investigator and/or symptom management service co-investigator, or as a result of patient's mood assessment questionnaire:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BKM120Also: BuparlisibTwo weeks after confirmatory biopsy, patients will begin taking 100 mg/day of BKM120. BKM120 will be given at this dose level orally once daily for 14 days prior to radical prostatectomy. Radical prostatectomy will be performed on the day of the last dose of BKM120 at day 14. No further drug will be administered after radical prostatectomy. For unforeseen delays in OR scheduling, up to 7 additional days of BKM120 may be administered prior to surgery. | Drug | Neoadjuvant BKM120 |
Primary outcome
Percentage of Participants With Decrease in Phosphorylated S6 Immunohistochemistry (ICH) From Baseline
Time frame: Up to 3 months
Percentage of men with downstream target inhibition of PI3K in prostate tumor tissue as measured by phosphorylated S6 immunohistochemistry (ICH) when treated with 100 mg/day of BKM120 using paired tumor biopsies from before and after drug administration and defined as ≥ 60% decrease in phosphorylated S6 (pS6) from baseline by Immunohistochemistry (IHC).
3 secondary outcomes
Percentage of Participants With Decrease in 4E-binding protein1 (p4EBP1) Protein Phosphorylation From Baseline
Time frame: Up to 3 months
Percentage of Participants With Decrease in AKT Protein From Baseline
Time frame: Up to 3 months
Number of Participants Displaying Activity of Short Term BKM120 Administration
Time frame: 1 Day, immediately prior to surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won Kim, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BKM120 in people with High Risk Prostate Cancer, run by Won Kim 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 28 inclusion and 35 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 13 Jan 2021. 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 13 Jan 2021). 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?
Percentage of Participants With Decrease in Phosphorylated S6 Immunohistochemistry (ICH) From Baseline (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2021.