A Trial of Irinotecan and BKM120 in Previously Treated Advanced Colorectal Cancer

Completed · Phase 1

Conditions studied: Colorectal Cancer

In brief

This phase I trial will use the combination of irinotecan and BKM120 in patients with advanced colorectal cancer who have failed on or have become intolerant of at least one line of therapy for advanced colorectal cancer and who are candidates for irinotecan therapy.

Key facts

Study ID

NCT01304602

Run by

University of Kansas Medical Center

People needed

20

Starts

2011-02-01

Expected to finish

2015-10-01

Last updated by the study team

2017-01-06

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed metastatic or unresectable adenocarcinoma of the colon or rectum with measurable disease (patients who have become resistant or intolerant of at least one-line of chemotherapy regimen are eligible)
• Patients who had had previous treatment with Irinotecan and who have definite progression on Irinotecan are eligible provided they are not a candidate for other therapeutic treatment options. Definitive progression is defined as progression of disease while on Irinotecan or within 4 weeks of discontinuing Irinotecan.
• ≥ 18 years old
• ECOG performance status ≤ 2 (Karnofsky > 60%)
• ANC ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L, Hb >9 g/dL
• Serum bilirubin within normal range (or < 1.5 x IULN if liver metastases present; or total bilirubin ≤ 3.0 x IULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)
• AST (SGOT) or ALT (SGPT) within normal range (or ≤ 3.0 x upper limit of normal if liver metastases present)
• adequate renal function as evidenced by creatinine ≤ 1.5 x IULN or creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
• serum calcium (corrected for serum albumin) within normal limits. Biphosphonate use for malignant hypercalcemia control is not allowed.
• Serum magnesium ≥ the institutional lower limit of normal (ILLN) and potassium within institutional normal limits.
• serum lipase ≤ IULN; serum amylase ≤ IULN; fasting plasma glucose ≤ 120 mg/dL (6.7 mmol/L)
• females of child-bearing potential must have negative serum pregnancy test within 72 hours prior to treatment. Cannot be pregnant or nursing.
• Males and females must agree to use effective contraceptive method.
• INR ≤ 2 Exclusion Criteria
• Previous treatment with chemotherapy, biologic therapy, or wide field radiotherapy < 4 weeks or limited field radiation for palliation < 2 weeks prior to starting study drug; must have recovered from side effects of such therapy
• Known hypersensitivity to BKM120 or to its excipients or to irinotecan
• Untreated brain metastases. Patients with metastatic CNS tumors may participate in this trial, if the patient is > 4 weeks from therapy completion, is clinically stable and is not receiving corticosteroid therapy
• Known polymorphism in UGTAIA or Gilbert's syndrome
• Acute or chronic liver, renal disease or pancreatitis
• Medically documented history or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, history of suicidal attempt or ideation, or homicidal ideation; ≥ CTCAE grade 3 anxiety; meets cutoff score of ≥ 10 in the PHQ-9 or cut-off of ≥ 15 in GAD-7 mood scale, respectively, or selects 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)
• Clinically significant heart disease including: Left ventricular ejection fraction (LVEF) <50% as determined by echocardiogram; 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 compromised cardiac function; symptomatic pericarditis; QTc > 480 msec on screening ECG (using QTcF formula; angina pectoris that requires use of anti-anginal medication
• History of cardiac dysfunction including: acute myocardial infarction ≤ 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function; history of documented congestive heart failure (NYHA Class III or IV; document cardiomyopathy
• Other concurrent severe and/or uncontrolled concomitant medical conditions
• Significant symptomatic deterioration of lung function. If clinically indicated, pulmonary function tests including measures of predicted lung volumes, DLco, O2 saturation at rest on room air should be considered to exclude pneumonitis or pulmonary infiltrates
• Clinical manifestation of diabetes mellitus or steroid-induced diabetes mellitus

Where it is running

• University of Kansas Cancer Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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