Phase 1, Dose-Escalation, Pharmacodynamic Study of IV CNF1010 in ZAP-70 Positive CLL

NCT00319930 | Terminated Phase 1

• 2 other identifiers: CNF1010-CLL-05001110CL101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of the study is to evaluate the effects of increasing doses of CNF1010 on pharmacodynamic markers and hematological response.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic lymphocytic leukemia; CLL; ZAP-70; Hsp90 inhibitor

Outcome Measures

Primary Outcomes (5)

• The minimal biologically active dose (MBAD)

• Safety and toxicity profile

• Pharmacokinetics (PK)

• Pharmacodynamics (PD)

• Clinical and hematological response

Interventions

CNF1010 (17-AAG) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• · 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (6)

Unknown Facility

Ocoee, Florida, 34761, United States

Location

Unknown Facility

Albany, New York, 12208, United States

Location

Unknown Facility

Dayton, Ohio, 45409, United States

Location

Unknown Facility

Greenville, South Carolina, 29605, United States

Location

Unknown Facility

Tyler, Texas, 75702, United States

Location

Unknown Facility

Norfolk, Virginia, 85258, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

tanespimycin

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 27, 2006
• First Posted: April 27, 2006
• Study Start: May 1, 2005
• Study Completion: May 1, 2007
• Last Updated: March 8, 2010

Record last verified: 2010-03

Locations

US (6)