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

This study has been completed.
Sponsor:
Information provided by:
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00473577
First received: May 11, 2007
Last updated: August 24, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Hematologic Neoplasms
Neoplasms
Drug: CRA-24781
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pharmacyclics:

Estimated Enrollment: 40
Study Start Date: August 2005
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473577

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60643
Sponsors and Collaborators
Pharmacyclics
Investigators
Principal Investigator: Samir Undevia, MD University of Chicago
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00473577     History of Changes
Other Study ID Numbers: PCYC 0401
Study First Received: May 11, 2007
Last Updated: August 24, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on September 29, 2014