BKM120 in Advanced, Metastatic, or Recurrent Endometrial Cancers

Withdrawn before enrolling · Phase 2

Conditions studied: Endometrial Cancer

In brief

This is a phase II open label fixed dose study in subjects with advanced, metastatic, or refractory endometrial or ovarian, fallopian tube, or primary peritoneal cancer with PI3 kinase pathway activation as demonstrated by PIK3CA gene mutation, PTEN gene mutation, or PTEN null/low protein expression.

Key facts

Study ID

NCT01550380

Run by

University of Utah

People needed

0

Starts

2014-05-01

Expected to finish

2014-07-01

Last updated by the study team

2014-07-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have advanced, metastatic, recurrent, or persistent endometrial or ovarian, fallopian tube, or primary peritoneal cancer.
• Tumor must demonstrate PI3 Kinase pathway activation: defined as PIK3CA gene mutation, PTEN gene mutation, or PTEN null/low protein expression.
• Prior therapy:
• Patients must not have had cytotoxic therapy directed at metastatic disease. Adjuvant chemotherapy is permitted.
• Patients must NOT have received any non-cytotoxic therapy for metastatic or recurrent disease, except for hormonal therapy or immunologic therapy.
• Patients with persistent or refractory disease after upfront surgery and adjuvant chemotherapy are eligible.
• Age ≥ 18 years
• ECOG performance status ≤ 2
• Patients must have at least one site of measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for solid tumors or the appropriate disease classification/criteria for the target population)
• Adequate bone marrow function as shown by: ANC ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L, Hb >9 g/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 (or ≤ 3.0 x upper limit of normal (ULN) if liver metastases are present)
• Serum bilirubin within normal range (or ≤ 1.5 x ULN if liver metastases are present; or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)
• Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL/min
• Serum amylase ≤ ULN
• Serum lipase ≤ ULN
• Fasting plasma glucose ≤ 120 mg/dL (6.7 mmol/L)
• Negative serum pregnancy test within 72 hours before starting study treatment in women with childbearing potential
• INR ≤ 2
• Able to provide informed consent \& have signed an approved consent form that conforms to federal \& institutional guidelines.

You may not qualify if…

• Patients who have received prior treatment with a P13K inhibitor.
• Patients with a known hypersensitivity to BKM120 or to its excipients.
• Patients with untreated brain metastases are excluded. However, patients with metastatic Central Nervous System (CNS) tumors may participate in this trial, if the patient is > 4 weeks from therapy completion (including radiation and/or surgery), is clinically stable at the time of study entry and is not receiving corticosteroid therapy (other than stable low dose corticosteroid therapy as outlined in exclusion criteria #14).
• Patients with acute or chronic liver, renal disease or pancreatitis
• Patients with the following mood disorders as judged by the Investigator or a psychiatrist, 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)
• ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety
• Meets the cut-off score of ≥ 10 in the PHQ-9 or a cut-off of ≥ 15 in the 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 unless overruled by the psychiatric assessment
• Patients with diarrhea ≥ CTCAE grade 2
• If patient is treated for diarrhea and it resolves to grade 1, patient may be enrolled.
• Patient has active cardiac disease including any of the following:
• Left ventricular ejection fraction (LVEF) < 50% as determined by Multiple Grated acquisition (MUGA) scan or echocardiogram (ECHO)
• QTc > 480 msec on screening ECG (using the QTcF formula)
• Angina pectoris that requires the use of anti-anginal medication
• 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 document compromise in cardiac function
• Symptomatic pericarditis
• Patient has a history of cardiac dysfunction including any of the following:
• Myocardial infraction within the last 6 months, documents by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function
• History of documents congestive heart failure (New York Heart Association functional classification III-IV)
• Documented cardiomyopathy
• Patient has poorly controlled diabetes mellitus or steroid-induced diabetes mellitus
• Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that, in the opinion of the investigator, could cause unacceptable safety risks or compromise compliance with the protocol

Where it is running

• Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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