Neoadjuvant BKM120 in High-risk Prostate Cancer

Stopped early · Phase 2

Conditions studied: High Risk Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01695473

Run by

Won Kim

People needed

11

Starts

2013-04-23

Expected to finish

2015-02-05

Last updated by the study team

2021-01-13

Who can join

Age: 18 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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)

You may not qualify if…

• 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)
• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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