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Study Evaluating Effects of CX-3543 in Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00485966
Recruitment Status : Withdrawn (This study was withdrawn prior to patient enrollment)
First Posted : June 13, 2007
Last Update Posted : November 5, 2008
Sponsor:
Information provided by:
Cylene Pharmaceuticals

June 11, 2007
June 13, 2007
November 5, 2008
June 2007
Not Provided
  • Efficacy
  • Safety
Efficacy, Safety
Complete list of historical versions of study NCT00485966 on ClinicalTrials.gov Archive Site
  • Clinical benefit
  • Pharmacodynamics
  • Study drug blood levels
  • Progression free survival
Clinical benefit, Pharmacodynamics, Study drug blood levels, Progression free survival,
Not Provided
Not Provided
 
Study Evaluating Effects of CX-3543 in Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
A Phase 2, Multi-Center, Open Label Study Evaluating Clinical Efficacy, Safety, and Pharmacodynamic Effects of Quarfloxacin (CX-3543) in Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)
This is a Phase 2, open-label, multicenter, efficacy, safety, and pharmacodynamic study of CX-3543 in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL).
The purpose of this trial is to evaluate the response rate, safety, pharmacodynamic effects, and duration of response of CX-3543 in patients with relapsed or refractory B-cell CLL.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
B-Cell Chronic Lymphocytic Leukemia
Drug: CX-3543
360 mg/m2 daily x 5 q 21 days
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
25
Same as current
June 2008
Not Provided

Inclusion Criteria:

  • Patients with B-cell CLL with indications for treatment by National Cancer Institute (NCI) Working Group criteria.
  • Measurable disease (lymphocytes ≥ 5,000/microliter, or palpable lymphadenopathy or bone marrow involvement > 30%).
  • Males and females 18 years of age or older.
  • Received a minimum of one prior purine analog-based chemotherapy regimen (e.g., fludarabine, cladribine, or pentostatin) and one monoclonal antibody therapy (e.g., Campath or Rituxan) but ≤ 4 chemotherapy regimens.
  • Patients must have central intravenous (IV) access, or agree to the insertion of a central line.
  • All previous cancer therapies, radiation, hormonal therapy and surgery, must have been discontinued at least 28 days prior to the start of treatment. Any cytotoxic chemotherapy must have been discontinued 28 days prior to the start of treatment. Acute toxicities from prior therapy must have resolved to Grade ≤ 1 above baseline.
  • Normal oxygen saturation with pulse oximetry on room air.
  • Hemoglobin ≥ 9 gm/dL (may be post-transfusion).
  • Platelet count ≥ 25,000/microliter.
  • Total bilirubin < 2 X upper limit of normal (ULN), and ALT and AST < 2 x ULN.
  • Serum creatinine within normal limits OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above the upper normal limit for the institution
  • ECOG Performance Status ≤ 1.
  • Anticipated survival of at least 3 months.
  • For men and women of child-producing potential, use of effective contraceptive methods during the study and for one month after discontinuation of treatment.
  • Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return to the clinic for required assessments.

Exclusion Criteria:

  • Pregnant or nursing women.
  • Severe chronic obstructive pulmonary disease with hypoxemia or an uncorrectable pulmonary compromise.
  • Seizures not controlled by anticonvulsant therapy.
  • Participation in any investigational drug study within 28 days before quarfloxacin administration.
  • Patients with second malignancy requiring active treatment.
  • Active symptomatic bacterial, fungal, or viral infection including active HIV or viral (A, B, or C) hepatitis.
  • Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis.
  • Patients who have exhibited allergic reactions to a similar structural compound (e.g., fluoroquinolones) or formulation (containing buffers and/or polyethylene glycol).
  • Patients with life- or function-threatening CLL complications (e.g., cord compression, hemolytic crisis, urinary tract obstruction).
  • Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any of the study's endpoints.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00485966
C3-07-001
No
Not Provided
Not Provided
Not Provided
Cylene Pharmaceuticals
Not Provided
Not Provided
Cylene Pharmaceuticals
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP