Clinical trial · Interventional
Sorafenib and Low Dose Cytarabine in Older Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
A Phase I/II Study of Sorafenib (BAY 43-9006) in Combination With Low Dose ARA-C (CYTARABINE) in Elderly Patients With AML or High-Risk MDS
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with cytarabine may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving sorafenib together with cytarabine and to see how well it works in treating older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sorafenib and Cytarabine
- description
- Cytarabine: subcutaneously twice daily from day 1 - 10. Sorafenib: Days 2-28; at the dose level assigned at registration. Sorafenib will be given orally twice daily.
- interventionNames
- Drug: cytarabine
Primary outcomes (3)
- measure
- Recommended phase II dose of sorafenib tosylate when given in combination with cytarabine (Phase I)
- timeFrame
- 29 months
- measure
- Dose-limiting toxicity (Phase I)
- timeFrame
- 29 months
- measure
- Complete remission (Phase II)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Acute myeloid leukemia (AML) by FAB criteria (By morphology and routine histochemistry and confirmed, when possible, by flow cytometric analysis of surface immunophenotype; co-expression of lymphoid markers permitted) * High-risk myelodysplastic syndromes defined as IPSS category of intermediate-2 or greater * Must be considered unsuitable for intensive chemotherapy regimens * No documented CNS involvement PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * AST and ALT ≤ 2 times upper limit of normal (ULN) * Bilirubin normal * Creatinine ≤ 1.2 times ULN OR creatinine clearance ≥ 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of other malignancies, except adequately treated nonmelanoma skin cancer, curatively treated in situ carcinoma of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years * No upper gastrointestinal or other conditions that would preclude compliance with or administration of oral medication * No serious illness or medical condition that would not permit the patient to be managed according to the protocol, including any of the following: * History of significant neurologic or psychiatric disorder that would impair the ability to obtain consent * Active, uncontrolled, serious infections * Active peptic ulcer disease * Evidence of bleeding diathesis * No myocardial infarction within the past 6 months * No congestive heart failure * No unstable angina * No active cardiomyopathy or unstable ventricular arrhythmia * No poorly controlled hypertension (e.g., systolic BP ≥ 150 mm Hg or diastolic BP ≥ 95 mm Hg) * No known hypersensitivity to the study drugs or their components * No preexisting hypothyroidism prior to enrollment unless patient is euthyroid on medication * No neuropathy ≥ grade 2 PRIOR CONCURRENT THERAPY: * At least 2 days since prior hydroxyurea * No other prior chemotherapy * No concurrent therapeutic doses (≥ 2 mg/day) of anticoagulants (e.g., warfarin) * Doses of up to 2 mg/day given for prophylaxis of thrombosis are accepted provided INR is ≤ 1.5 * No other concurrent experimental drugs or anticancer therapy
References
Publications (1)
- RESULTMacdonald DA, Assouline SE, Brandwein J, Kamel-Reid S, Eisenhauer EA, Couban S, Caplan S, Foo A, Walsh W, Leber B. A phase I/II study of sorafenib in combination with low dose cytarabine in elderly patients with acute myeloid leukemia or high-risk myelodysplastic syndrome from the National Cancer Institute of Canada Clinical Trials Group: trial IND.186. Leuk Lymphoma. 2013 Apr;54(4):760-6. doi: 10.3109/10428194.2012.737917. Epub 2012 Nov 15. PMID 23061485