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Advanced Prostate CancerPhase 2NCT02035124

Cabazitaxel and BKM120 in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel

A Phase 2 study testing BKM 120 and Cabazitaxel in people with Advanced Prostate Cancer, run by SCRI Development Innovations, LLC at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Although there have been advances in the treatment of patients with metastatic castrate-resistant prostate cancer (mCRPC), all patients eventually develop resistance to available therapy. Docetaxel is the accepted first-line agent followed by cabazitaxel in the post-docetaxel phase. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Advanced Prostate Cancer
What is being tested?
BKM 120 and Cabazitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesUnited States
Study dates
Apr 2014to Jan 2015
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Adenocarcinoma of the prostate confirmed histologically.
  • Metastatic disease confirmed by biopsy or imaging studies.
  • Patients must have received treatment with docetaxel as the only previous chemotherapy regimen. In addition, previous treatment with hormonal agents and/or immune therapy is allowed (e.g., abiraterone). (Previous treatment with MDV3100 will also be allowed.)
  • Patients must be castrate-resistant (i.e. developed progression of metastases following surgical castration or during medical androgen ablation therapy) with documented castrate levels of testosterone (<50 ng/dl).
  • Patients receiving medical castration therapy with gonadotropin-releasing hormone (GnRH) analogues should continue this treatment during this study.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2.
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  • Patient must have progressive metastatic prostate cancer by at least 1 of the following criteria:
  • Soft tissue disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Bone scan progression defined by 2 or more new lesions on bone scan.
  • Prostate specific antigen (PSA) progression is determined by a minimum of three rising PSA levels with an interval of ≥1 week between each determination. The screening PSA measurement (documenting progression) must be ≥2 ng/mL.
  • Screening PSA ≥2 ng/mL.
  • Adequate hematologic, renal and hepatic function:
  • Adequate serum chemistries.
  • Ability to swallow and retain oral medication.
  • Life expectancy of ≥6 months.
  • Patients must be ≥18 years of age.
  • Patients entering this study must be willing to provide tissue from a previous tumor biopsy or 15 unstained slides (if available) for correlative testing. If tissue is not available, a patient will still be eligible for enrollment into the study.
  • Ability to understand the nature of this study and give written informed consent.

Who cannot join

  • Previous treatment with PI3K inhibitors.
  • Known hypersensitivity to BKM120 or polysorbate-80 or any of the excipients or taxanes.
  • Use of an investigational drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of BKM120. For investigational drugs for which 5 half-lives is ≤21 days, a minimum of 10 days between termination of the investigational drug and administration of BKM120 is required.
  • Previous chemotherapy with any agent other than docetaxel. All patients must be ≥28 days after their most recent chemotherapy and have recovered from side effects.
  • Patient has received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) ≤28 days or limited field radiation for palliation ≤7 days prior to starting study drug or has not recovered from side effects of such therapy.
  • Major surgical procedures ≤28 days of beginning study drug, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement.
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  • Clinical significant peripheral neuropathy (defined as CTCAE v4.0 Grade ≥2) regardless of causality.
  • Mood disorders as judged by the Investigator or a Psychiatrist, or who meets the cut-off score of ≥12 in the Patient Health Questionnaire (PHQ)-9 or a cut-off score of ≥ 15 in the Generalized Anxiety Disorder (GAD)-7 mood scale, respectively, or selects a positive response of '1, 2, or 3' to question 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score or the PHQ-9)
  • anxiety or depression ≥ Grade 3
  • 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, or patients with active severe personality disorders (defined according to DSM- IV) are not eligible. Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified
  • Previously untreated brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if there is no evidence of central nervous system (CNS) disease progression, and at least 28 days (4 weeks) have elapsed since treatment. Patients are not permitted to receive enzyme inducing anti-epileptic drugs (EIAEDs) during the study and should not be receiving chronic corticosteroid therapy for CNS metastases.
  • Leptomeningeal metastases or spinal cord compression due to disease.
  • Acute or chronic liver, renal disease or pancreatitis.
  • Uncontrolled diabetes mellitus. Type II diabetics are eligible if they require only oral hypoglycemic agents and fasting blood glucose level is ≤120. Type I diabetics are eligible if HbAlc is <8.
  • Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea Grade ≥2, and malabsorption syndrome).
  • Any of the following cardiac diseases currently or within the last 6 months:
  • Left Ventricular Ejection Fraction (LVEF) <50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)
  • QTc > 480 ms on screening ECG
  • Unstable angina pectoris
  • Congestive heart failure (New York Heart Association [NYHA] ≥ Grade 2
  • Acute myocardial infarction
  • Conduction abnormality not controlled with pacemaker or medication
  • Significant ventricular or supraventricular arrhythmias (Patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible.)
  • Valvular disease with significant compromise in cardiac function.
  • Family history of congenital long or short QT, or known history of QT/QTc prolongation or Torsades de Pointes (TdP). Patients who are currently receiving treatment with medication that has the potential to prolong the QT interval or induce TdP and the treatment cannot either be discontinued or switched to a different medication prior to starting study treatment.
  • Inadequately controlled hypertension (i.e., SBP>180 mmHg or DBP>100mmHg). (Patients with values above these levels must have their BP controlled with medication prior to starting treatment)
  • Patient receiving chronic treatment with systemic steroids or another immunosuppressive agent at the start of study treatment.
  • Note: Topical applications (e.g. rash), inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) are allowed.
  • Patients receiving drugs known to be moderate and strong inhibitors or inducers or isoenzyme cytochrome P450 (CYP) 3A (CYP3A) that cannot be discontinued or switched to different medication prior to starting study drug.
  • Patients who have taken herbal medications and certain fruits ≤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 include the CYP3A inhibitors Seville oranges, grapefruit, pummelos, or exotic citrus fruits.
  • Patients currently receiving treatment with therapeutic doses of warfarin sodium. Patients receiving low molecular weight heparin are allowed.
  • A serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
  • Known diagnosis of human immunodeficiency virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV).
  • Presence of other active cancers, or history of treatment for invasive cancer ≤5 years. Patients with stage I cancer who have received definitive local treatment at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e. non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  • Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
  • Fertile male patients, defined as all males physiologically capable of conceiving offspring must use a highly effective contraception during dosing any study agent + [5 x T1/2] +12 weeks = contraception through 16 weeks after final dosing of study therapy and should not father a child during this period. In addition, female partners of male patients must use a highly effective contraception during dosing of any study agent + [5 x T1/2] +12 weeks = contraception through 16 weeks after the final dose of study therapy.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Florida Cancer Specialists-South

    Fort Myers, Florida, 33916

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

Other trials in United States

About this study

Official title: Cabazitaxel With BKM120 in Patients With Metastatic Castrate-Resistant Prostate Cancer Following Treatment With Docetaxel: Phase II Study With Safety Lead-in Cohort

Although there have been advances in the treatment of patients with metastatic castrate-resistant prostate cancer (mCRPC), all patients eventually develop resistance to available therapy. Docetaxel is the accepted first-line agent followed by cabazitaxel in the post-docetaxel phase. In this study the investigators propose to evaluate BKM120, a PI3K inhibitor, with cabazitaxel in the treatment of patients with advanced prostate cancer.

Read the detailed description

This study will be conducted in two parts. In a lead-in cohort, the feasibility and safety of administering BKM120 with a standard dose of cabazitaxel will be assessed. If safety is confirmed, a subsequent Phase II portion will assess the activity of the combination in patients with mCRPC previously treated with docetaxel. The treatment will consist of 3-week (21-day) cycles.

The ultimate purpose of this study will be to determine progression-free survival, response rate, disease control rate and overall survival of patients treated with the combination regimen and compare outcomes to historical results with single-agent cabazitaxel.

Being tested
BKM 120, Cabazitaxel
Keywords
Prostate, Metastatic, Refractory, mCRPC
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • BKM 120Drug

    Also called BKM 120 (Buparlisib)

  • CabazitaxelDrug

    Also called Jevtana

Study groups in NCT02035124
Study groupRoleWhat they receive
BKM120 and CabazitaxelExperimentalBKM 120 orally once daily; Cabazitaxel 25 mg/m2 IV every 3 weeks
Receives: Drug: BKM 120; Drug: Cabazitaxel

What is being measured

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

  1. Number of Subjects with Serious and Non-Serious Adverse Events

    Determine the optimal dose and safety of BKM120 given with cabazitaxel to patients with metastatic castrate-resistant prostate cancer.

    Measured: up to 24 months

  2. Progression Free Survival (PFS)

    time to disease progression

    Measured: every 6 weeks, up to 24 months

Secondary outcomes (2)

  1. Overall Response Rate

    Percentage of complete responders (CR) or partial responders (PR) among patients evaluable for response

    Measured: every 6 weeks, up to 24 months

  2. Overall Survival

    Time from first treatment until death from any cause using Kaplan-Meier methods.

    Measured: up to 36 months

Timeline

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

  1. First posted14 Jan 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionJan 2015
  4. Study completionJan 2015

Why it stopped: Study withdrawn due to slow accrual. No patients were enrolled.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02035124
Sponsor's protocol ID
SCRI GU 79
Status last verified
Feb 2016
First submitted
10 Jan 2014
Last updated
11 Feb 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BKM 120 and Cabazitaxel in people with Advanced Prostate Cancer, run by SCRI Development Innovations, LLC 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 18 inclusion and 37 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: withdrawn, as of the sponsor's last update on 11 Feb 2016. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Number of Subjects with Serious and Non-Serious Adverse Events (time frame: up to 24 months). The study lists 2 primary outcomes in all. 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 NCT02035124.

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 11 Feb 2016.

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