- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00319930
Phase 1, Dose-Escalation, Pharmacodynamic Study of IV CNF1010 in ZAP-70 Positive CLL
A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Pharmacodynamic Study of Intravenously Administered CNF1010 (17-(Allylamino)-17-demethoxy-geldanamycin [17-AAG]) in Patients With ZAP-70 Positive B-Cell Chronic Lymphocytic Leukemia (CLL)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Florida
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Ocoee, Florida, United States, 34761
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New York
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Albany, New York, United States, 12208
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Ohio
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Dayton, Ohio, United States, 45409
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South Carolina
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Greenville, South Carolina, United States, 29605
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Texas
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Tyler, Texas, United States, 75702
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Virginia
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Norfolk, Virginia, United States, 85258
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria:
Diagnosis of B-cell CLL including
- Lymphocytosis of >=5,000 monoclonal B-cells/microliter co-expressing >= one B-cell marker (CD19, CD20, or CD23) and CD5 in peripheral blood AND
- <= 55% prolymphocytes AND
- Bone marrow with >=30% mononuclear cells being lymphocytes
- ZAP-70 positive CLL
Intermediate or High risk, poor prognosis CLL refractory to fludarabine-based therapy as defined by one of the following:
- Disease progression following 2 cycles of fludarabine OR
- Failure to achieve PR or CR after at least 2 cycles OR
- No response to treatment or stable disease after at least 2 cycles of fludarabine OR
- Disease progression after chemotherapy treatment after fludarabine-based therapy
OR
· CLL patients intolerant to fludarabine-based therapy. [Intolerance is defined as the development of any serious medical condition occurring after exposure to fludarabine that would restrict further use of the agent as treatment for the patient's CLL (i.e., autoimmune hemolytic anemia, myelosuppression, hypersensitivity)]
- Indication for treatment as defined by the NCI Working Group Guidelines
Laboratory parameters as follows:
- Hemoglobin >=10 g/dL (may be post-transfusion); platelet count >=50 x103/mm3
- T. Bili <2 x ULN and ALT and AST <2 x ULN
- Creatinine <=2 x ULN
- ECOG Performance Score <=2
- For patients of child-producing potential, use of effective contraceptive methods during the study and for 1 month following treatment
Key Exclusion Criteria:
- Pregnant or nursing women
- Class III or IV cardiac disease defined by the New York Heart Association Functional Classification and/or left ventricular ejection fraction <40%
- History of prior radiation that potentially included the heart in the field.
- History of myocardial infarction or active ischemic heart disease within 6 months of study entry
- History of arrhythmia (including atrial fibrillation, multifocal premature ventricular contractions, ventricular bigeminy or trigeminy, ventricular tachycardia or a requirement for antiarrhythmics (including digoxin)
- Baseline QTc >=450 msec for men and >= 470 msec for women in the absence of correctable electrolyte imbalance
- Poorly controlled angina
- Congenital long QT syndrome or first-degree relative with unexplained sudden death <40 years of age
- Presence of left bundle branch block
- Treatment with chemotherapy, monoclonal antibody or radiotherapy within 28 days of study entry
- Severe or debilitating pulmonary disease
- Participation in any investigational drug study within 28 days prior to CNF1010 administration. (Patient must have recovered from all acute effects of previously administered investigational agents)
- Presence of active malignancy with the exception of basal cell carcinoma
- Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral (A, B or C) hepatitis
- Known allergy to soy
- Requirement for concomitant therapy with drugs that alter metabolism by cytochrome P450 3A4 except low-dose warfarin for implanted device patency
- Requirement for concomitant therapy with drugs that prolong or may prolong QTc interval
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Pharmacokinetics (PK)
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Pharmacodynamics (PD)
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The minimal biologically active dose (MBAD)
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Safety and toxicity profile
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Clinical and hematological response
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNF1010-CLL-05001
- 110CL101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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