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Study of the Tolerability, Safety, and Pharmacokinetics of CRA-024781 in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00473577
Recruitment Status : Completed
First Posted : May 15, 2007
Last Update Posted : August 25, 2010
Information provided by:
Pharmacyclics LLC.

Brief Summary:
To determine the maximum tolerated dose (MTD) of CRA-024781 IV given by 2-hour intravenous infusions in patients with refractory solid or hematologic malignancies. To evaluate safety and tolerability, pharmacokinetics and pharmacodynamics, and to evaluate bioavailability of CRA-024781 IV when administered in a single oral dose.

Condition or disease Intervention/treatment Phase
Hematologic Neoplasms Neoplasms Drug: CRA-24781 Phase 1

Detailed Description:

Patients will receive a single oral dose of CRA-024781 one week before beginning intravenous dosing. Blood samples for pharmacokinetic and pharmacodynamic analysis will be collected on several occasions prior to the start of the intravenous treatment.

The intravenous treatment will consist of 3 consecutive days of CRA-024781 IV administered as a 2-hour IV infusion every 3 weeks in a 4 weeks cycle.

Assessment of the extent of disease will be performed every 8 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Two Phase, Open-Label, Sequential, Ascending Dose Study of the Tolerability, Safety, and Pharmacokinetics of CRA-024781 in Cancer Patients
Study Start Date : August 2005
Actual Primary Completion Date : November 2007
Actual Study Completion Date : December 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • age ≥ 18 years
  • histologically confirmed solid or hematologic malignancy that is refractory to standard therapy or for which no standard therapy exists
  • estimated life expectancy > 12 weeks
  • ECOG performance grade ≤ 2
  • creatinine ≤ 1.5 X institutional upper limit of normal or creatinine clearance > 50 mL/min
  • total bilirubin within institutional limits (unless elevated from documented Gilbert's syndrome)
  • AST and ALT ≤ 2.5 X institutional upper limit of normal (≤ 5 x institutional upper limit of normal in the presence of liver metastases)
  • platelet count ≥ 100,000/µL
  • absolute neutrophil count (ANC) ≥ 1500/µL
  • Hgb ≥ 9.0 g/dL
  • patients with previously treated brain metastases who are not on corticosteroids are eligible
  • effective contraceptive method (e.g., intrauterine device, oral contraceptive, or barrier device) must be used during the study by male and female patients of childbearing potential
  • ability to understand and willingness to sign a written informed consent

Exclusion Criteria:

  • patients who have had immunotherapy, chemotherapy, or radiotherapy within 4 weeks (within 6 weeks for nitrosoureas or mitomycin C) prior to study entry; study entry defined as first day of drug dosing
  • patients who have undergone major surgery within 4 weeks prior to study entry
  • patients who are receiving another investigational drug
  • patients with active CNS metastases or leptomeningeal disease not controlled by prior surgery or radiotherapy
  • uncontrolled illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV heart failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric illness that would limit compliance with study requirements
  • risk factors for QTc prolongation and/or Torsade de Pointes
  • patients with known HIV infection
  • concurrent systemic hormonal therapy except: stable LHRH agonist therapy for prostate cancer; hormonal therapy (e.g., megestrol) for appetite stimulation; nasal, ophthalmic, and topical glucocorticoid preparations when appropriate; stable oral glucocorticoid and mineralocorticoid replacement for adrenal insufficiency; or oral contraceptives
  • patients who have other medical or psychiatric illness or organ dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with the evaluation of the safety of the study agent
  • pregnant or lactating women (female patients must have a negative serum pregnancy test within 7 days of study entry)
  • patients who have previously received histone deacetylase inhibitors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00473577

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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60643
Sponsors and Collaborators
Pharmacyclics LLC.
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Principal Investigator: Samir Undevia, MD University of Chicago

Additional Information:
Layout table for additonal information Identifier: NCT00473577     History of Changes
Other Study ID Numbers: PCYC 0401
First Posted: May 15, 2007    Key Record Dates
Last Update Posted: August 25, 2010
Last Verified: August 2010
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action