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View Clinical Trial (Medical Research Study)
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A Phase 1/2a Study of ABT-263 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia - NCT00481091-92093 (Clinical Trial 171152)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy171152.aspx
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| City: |
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San Diego |
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State:
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CA |
| Zip Code: |
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92093 |
| Conditions: |
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Chronic Lymphocytic Leukemia |
| Purpose: |
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The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of
ABT-263 under two different dosing schedules with the objective of defining the dose
limiting toxicity and maximum tolerated dose.
The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2
dose to obtain additional safety information and a preliminary assessment of efficacy.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Relapsed or refractory CLL and require treatment (Phase 1).
- Relapsed CLL requiring treatment and has received no more than 5 prior treatment
regimens (Phase 2a)
- Eastern Cooperative Oncology Group performance score < or = 1
- Must be on a stable dose of Selective Serotonin Reuptake Inhibitor (SSRI)
anti-depressants (e.g. Prozac) 21 days prior to starting ABT-263
- Must have adequate bone marrow, renal and hepatic function per local laboratory
reference range as follows: ANC >= 1000/microL, Platelets >= 75,000/mm³ (entry
platelet count must be independent of transfusion within 14 days of Screening),
Hemoglobin > or = 9.0 g/dL, Serum creatinine < or = 2.0 mg/dL or calculated
creatinine clearance > or = 50 mL/min, AST and ALT < or = 3.0 x ULN of institution's
normal range, Bilirubin < or =1.5 x ULN, Gilbert's Syndrome patients may have a
Bilirubin > 1.5 x ULN, Coagulation: aPTT, PT must not exceed 1.2 x ULN;
- Surgically sterile or postmenopausal (for at least 1 year), or a negative pregnancy
test performed as follows: At Screening on a serum sample obtained within 14 days
prior to initial study drug administration, and prior to dosing on a urine sample
obtained on Day 1 if it has been > 7 days since obtaining the serum pregnancy test
results
- All female subjects not surgically sterile or postmenopausal (for at least 1 year)
and non-vasectomized male subjects must practice at least one of the following
methods of birth control: total abstinence from sexual intercourse (minimum 1
complete menstrual cycle); a vasectomized partner; hormonal contraceptives (oral,
parenteral or transdermal) for at least three months prior to study drug
administration; double-barrier method (including condoms, contraceptive sponge,
diaphragm or vaginal ring with spermicidal jellies or cream)
- Voluntarily sign and date informed consent, approved by an Independent Ethics
Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any
screening or study-specific procedures.
Exclusion Criteria:
- Has a history or is clinically suspicious for cancer-related CNS disease
- Recent history (within 1 year prior to 1st dose of study drug) of an underlying,
predisposing condition of bleeding or exhibits signs of bleeding
- Allogeneic or autologous stem cell transplant
- Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis
- Active immune thrombocytopenic purpura or history of being refractory to platelet
transfusions (within 1 year prior to 1st dose of study drug)
- Receiving or requires anticoagulation therapy or any drugs or herbal supplements that
effect platelet function, with the exception of low dose anti-coagulation meds used
to maintain the patency of a central intravenous catheter
- Received aspirin within 7 days prior to 1st dose of study drug
- Received steroid therapy for anti-neoplastic intent within 7 days prior to the 1st
dose of study drug with the exception of inhaled steroids for asthma, topical
steroids, or replacement/stress corticosteroids
- Received anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy,
hormonal (with the exception of hormones for thyroid conditions or estrogen
replacement therapy (ERT), or any investigational therapy within 28 days prior to 1st
dose of study drug
- Has received a biologic within 30 days prior to 1st dose of study drug
- Significant history of cardiovascular, renal, neurologic, psychiatric,
endocrinologic, metabolic, immunologic, or hepatic disease that would adversely
affect his/her participating in this study
- Female is pregnant or breast-feeding
- Tested positive for HIV
- Other active malignancies within the past 3 years, with the exception of: adequately
treated in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma of
the skin; previous malignancy confined and surgically resected with curative intent
- Exhibits evidence of other clinically significant uncontrolled condition(s)
including, but not limited to: uncontrolled systemic infection (viral, bacterial, or
fungal); diagnosis of fever and neutropenia within 1 week prior to study drug
administration |
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| Study is available at: |
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UCSD Moores Cancer Center
San Diego, CA 92093
United States
Primary Contact:
Vineeta Prasad
Email: vprasad@ucsd.edu
Phone: 858-822-0337
Secondary Contact:
Melissa Kumar, BS
Email: melissa.kumar@abbott.com
Phone: 847-938-3885 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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