Safety Study of Bevacizumab, Everolimus and LBH589 (BEL) for Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

The main purpose of this study is to test the safety of three study drugs, bevacizumab (Avastin™), Everolimus (Afinitor™) and LBH589 (Panobinostat) when they are given together. It is hoped this study drug combination might lead to a greater decrease the in size of the cancer and/or slow down how fast the cancer is growing compared to when these drugs are given alone. Subjects will be enrolled at Duke University Medical Center (DUMC).

Key facts

Study ID

NCT01055795

Run by

Herbert Hurwitz

People needed

14

Starts

2010-03-01

Expected to finish

2012-05-01

Last updated by the study team

2012-12-24

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically and/or cytologically confirmed malignant solid tumor that is refractory to standard therapies, or for which no standard therapies exist.
• Patients must have at least one measurable site of disease according to RECIST (see Appendix 1) criteria that has not been previously irradiated. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation
• Age ≥ 18 years
• Karnofsky Performance status ≥ 80% (see Appendix 2)
• Adequate bone marrow function as shown by:
• ANC ≥ 1.5 x 109/L
• Platelets ≥ 100 x 109/L
• Hemoglobin >9 g/dL; Erythropoietin and transfusion support is permitted provided treatments are not required more than every 8 weeks.
• Adequate liver function as shown by:
• serum bilirubin ≤ 1.5 x ULN
• INR ≤ 1.5
• ALT and AST ≤ 2.5x ULN (≤ 5x ULN in patients with liver metastases)
• Adequate renal function: creatinine clearance (estimated) ≥ 40 cc/min
• Fasting serum cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. NOTE: Use of standard lipid lowering agents (see Section 10.3.6 for guidance) is permitted to meet eligibility.
• Fasting blood sugar <160 mg/dL.
• Baseline MUGA or ECHO must demonstrate LVEF ≥ 50%
• TSH and free T4 within normal limits; Patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism.
• Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days from day 1 of study drug and must be willing to use two methods of contraception, one of them being a barrier method during the study and for 3 months after last study drug administration
• Signed informed consent

You may not qualify if…

• Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks from day 1 of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc.)
• Patients who:
• have had a major surgery or significant traumatic injury within 4 weeks from day 1 of study drug,
• have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or
• are anticipated to require major surgery during the course of the study.
• Patients with a known hypersensitivity to experimental drugs (or classes of drugs) or their excipients
• Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent with the following exceptions:
• Intermittent steroids ( not to exceed 4 mg every day) may be used on an as-needed basis (e.g. treatment for chemotherapy-related nausea.)
• Patients on physiologic replacement doses of steroids due to adrenal insufficiency for any reason may remain on these medications.
• Topical, inhaled or intra-articular corticosteroids
• Patients should not receive immunization with attenuated live vaccines within one week of day 1 of study drug or during study period
• Active brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases. Treated, asymptomatic metastases are permitted provided the patient has been off steroids for at least 1 month prior to day 1 of study drug.
• Clinically significant arrhythmias including complete left bundle branch block or use of a permanent cardiac pacemaker, congenital long QT syndrome, history or presence of ventricular tachyarrhythmias, 2nd degree AV block type II, 3rd degree AV block clinically significant resting bradycardia (<50 beats per minute), QTcF > 450 msec on screening ECG.
• Presence of poorly controlled atrial fibrillation (ventricular heart rate >100 bpm)
• Previous history of CVA, TIA, angina pectoris, acute MI or history of recent re-perfusion procedures (e.g. PTCA) within 6 months from day 1 of study drug.
• Congestive heart failure (New York Heart Association (NYHA classification, see Appendix 4 functional classification III-IV).
• Fasting blood sugar > 160 mg/dL despite standard of supportive care. Patients may start or adjust anti-diabetic medications to meet eligibility.
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study as so judged by the treating physician. Examples include but are not limited to:
• Severely impaired lung function (e.g. use of home O2, history of Idiopathic Lung Disease (ILD), any evidence of ILD on scan.
• Active (acute or chronic) or uncontrolled severe infections requiring treatment with antibiotics
• Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
• Uncontrolled hypertension, BP>150/100 despite medical management
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of oral medications (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
• Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to day 1 of study drug
• History of hemoptysis (>/= 1/2 teaspoon of bright red blood per episode) within 1 month prior to day 1 of study drug

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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