Entinostat and Sorafenib Tosylate in Treating Patients With Advanced or Metastatic Solid Tumors or Refractory or Relapsed Acute Myeloid Leukemia

Stopped early · Phase 1

Conditions studied: Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Blastic Phase Chronic Myelogenous Leukemia, Recurrent Adult Acute Myeloid Leukemia, Unspecified Adult Solid Tumor, Protocol Specific

In brief

This phase I trial is studying the side effects and the best dose of entinostat when given together with sorafenib tosylate in treating patients with advanced or metastatic solid tumors or refractory or relapsed acute myeloid leukemia. Entinostat and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT01159301

Run by

National Cancer Institute (NCI)

People needed

44

Starts

2010-06-01

Last updated by the study team

2013-09-19

Who can join

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

You may qualify if…

• Must meet 1 of the following criteria:
• Histologically or cytologically confirmed solid tumors (dose-escalation only)
• Locally advanced, inoperable, or metastatic disease
• Evaluable or measurable disease
• Diagnosis of acute myeloid leukemia (AML) for which no other standard therapy, including stem cell transplantation, is expected to result in meaningful clinical response (expansion cohort only)
• Refractory or relapsed disease
• Chronic myelogenous leukemia in blast crisis allowed
• No acute promyelocytic leukemia with t(15;17)
• Must consent to have fresh tumor, bone marrow aspirate, and biopsy obtained
• No untreated, symptomatic, or unstable brain metastases
• No active CNS involvement for patients with AML
• ECOG performance status 0-1
• ANC ≥ 1,500/mm³ (dose-escalation only)
• Platelet count ≥ 100,000/mm³ (dose-escalation only)
• Hemoglobin ≥ 10 g/dL (dose-escalation only)
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• ALT and AST ≤ 3 times ULN (≤ 5 times ULN for liver metastasis)
• Creatinine clearance ≥ 40 mL/min
• Albumin > 3.0 g/dL
• Plasma phosphorus > lower limit of normal (with supplementation)
• INR ≤ 1.5
• APTT ≤ 1.5 times ULN (if not on anticoagulants)
• Able to swallow oral medications
• ≥ 16 years old (expanded cohort patients recruited at the University of Colorado site)
• Must have tolerated prior sorafenib tosylate (dose: 400 mg twice daily), if applicable

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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