Status:
TERMINATED
Sorafenib for the Treatment of Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
Thomas Kipps
Collaborating Sponsors:
Bayer
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2 trial to evaluate the activity of sorafenib in relapsed or refractory CLL patients with an iwCLL-WG indication to receive therapy. Sorafenib is an orally active multikinase inhibito...
Detailed Description
The UCSD Moores Cancer is conducting a Phase 2 clinical trial to evaluate the activity of sorafenib in relapsed or refractory CLL patients. Sorafenib (BAY 43-9006) is an oral multi-kinase inhibitor w...
Eligibility Criteria
Inclusion
- Diagnosis of relapsed or refractory CLL.
- Experiencing progressive disease with an iwCLL-WG indication to receive therapy.
- Age ≥ 18 years.
- ECOG performance status ≤ 2 at study entry.
- Adequate organ and marrow function as defined below:
- platelets ≥ 50 x 109/L
- serum creatinine ≤ 1.5 mg/dL
- total bilirubin ≤ 1.5 mg/dL
- AST(SGOT)/ALT(SPGT) ≤ 2 X institutional upper limit of normal or if known liver involvement \<5X institutional upper limit of normal
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent.
Exclusion
- No investigational agents within 28 days prior to entering the study.
- No concurrent use of other anti-cancer agents or treatments.
- No congestive heart failure \> class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (beginning within the last 3 months) or myocardial infarction within the past 6 months.
- No known brain metastases (progressive neurologic dysfunction may confound the evaluation of neurologic and other adverse events).
- No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- No uncontrolled hypertension defined as systolic blood pressure \> 140 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
- No known active Hepatitis or HIV.
- No history of allergic reactions attributed to compounds sorafenib or its excipients.
- No uncontrolled intercurrent illness such as ongoing or active infection (fungal, bacterial, and/or viral), CTCAE grade 2 or greater.
- No thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- No serious non-healing wound, ulcer, or bone fracture.
- No major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
- No condition that may impair the patient's ability to swallow whole pills.
- Patient must not have any malabsorption problem.
- Patients receiving St. John's Wort or rifampin (rifampicin) are ineligible.
- Patients with uncontrolled Autoimmune Hemolytic Anemia (AIHA) or autoimmune thrombocytopenia (ITP) are ineligible.
- Patients must not be experiencing psychiatric illness/social situations that would limit compliance with study requirements.
- Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from CLL except cervical cancer in-situ, treated basal cell carcinoma, squamous cell carcinoma of the skin, or superficial bladder tumor (Ta and Tis). Subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before study entry are allowed. All cancer treatments must be completed at least 3 years prior to study entry (ie, signature date of the informed consent form).
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01510756
Start Date
December 1 2011
End Date
December 1 2014
Last Update
January 21 2016
Active Locations (1)
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1
UCSD Medical Center
La Jolla, California, United States, 92093