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Sponsored by: |
Pharmacyclics |
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Information provided by: | Pharmacyclics |
ClinicalTrials.gov Identifier: | NCT00473577 |
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 |
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Hematologic Neoplasms Neoplasms |
Drug: CRA-24781 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Two Phase, Open-Label, Sequential, Ascending Dose Study of the Tolerability, Safety, and Pharmacokinetics of CRA-024781 in Cancer Patients |
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) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | PCYC 0401 |
Study First Received: | May 11, 2007 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00473577 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hematologic Neoplasms Hematologic Diseases |
Neoplasms Neoplasms by Site Hematologic Neoplasms Hematologic Diseases |