BKM120 + Carboplatin + Paclitaxel for Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

The purpose of this study is to find out the good and bad effects that occur when BKM120 is added to standard chemotherapy with carboplatin and paclitaxel.

Key facts

Study ID

NCT01297452

Run by

Memorial Sloan Kettering Cancer Center

People needed

45

Starts

2011-02-15

Expected to finish

2017-03-29

Last updated by the study team

2017-03-31

Who can join

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

You may qualify if…

• Pathologically confirmed recurrent or metastatic advanced solid tumor, for which there is no curative-intent treatment option. Pathology confirmation must be performed at MSKCC.
• Age ≥ 18 years
• ECOG performance status ≤ 1
• Life expectancy of ≥ 12 weeks
• Adequate bone marrow function as shown by: ANC ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L, Hemoglobin > 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
• Adequate liver function.
• Serum bilirubin must be within the upper limit of normal. (ULN). AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used.
• Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 55 mL/min
• Fasting plasma glucose (FPG) ≤120 mg/dL or ≤6.7 mmol/L
• HbA1c ≤ 8%
• Negative serum pregnancy test within 14 days before starting study treatment in women with childbearing potential
• Ability to swallow oral medication
• EXPANSION COHORT B ONLY: Documented genetic alteration (mutation or homozygous deletion) in the PTEN gene, identified by the MSKCC IMPACT assay platform or other CLIA-approved test.

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 CNS tumors may participate in this trial, if the patient is > 4 weeks from therapy completion (incl. radiation and/or surgery), is clinically stable at the time of study entry and is not receiving corticosteroid therapy
• 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 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)
• ≥ CTCAE grade 3 anxiety
• At screening, mood rating scores of ≥ 10 on PHQ-9 and/or ≥ 15 on GAD-7, unless overruled by psychiatrist's assessment
• Patient selects a response of "1, 2, or 3" for question 9 on PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9) Note: The psychiatric judgment overrules the mood assessment questionnaire result/investigators judgment. If mood rating scores do not meet eligibility criteria and/or the investigator deems that a patient has mood disorder that renders the patient ineligible, that patient may not be registered to the study unless there is a subsequent psychiatric clinic consultation in which the psychiatrist overrules the mood assessment questionnaire result/investigator judgment.
• Patients with diarrhea ≥ CTCAE grade 2
• Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
• ST depression or elevation of ≥ 1.5 mm in 2 or more leads
• Congenital long QT syndrome
• History or presence of sustained ventricular arrhythmias or atrial fibrillation
• Clinically significant resting bradycardia (< 50 beats per minutes) QTc > 480 msec on screening ECG
• Complete left bundle branch block
• Right bundle branch block + left anterior hemiblock (bifascicular block)
• Unstable angina pectoris ≤ 6 months prior to starting study drug
• Acute myocardial infarction ≤ 6 months prior to starting study drug
• Other clinically significant heart disease such as congestive heart failure requiring treatment (NYHA Class III or IV) or uncontrolled hypertension (please refer to WHO-ISH guidelines)
• Patients with uncontrolled 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
• Patients who have been treated with any hematopoietic 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
• Patients who are currently receiving treatment with QT prolonging medication with a known risk to induce Torsades de Pointes and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug. Please refer to Appendix E for a list of prohibited drugs.

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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