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| Sponsor: | Hana Biosciences, Inc |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Hana Biosciences, Inc |
| ClinicalTrials.gov Identifier: | NCT00088023 |
Purpose
The purpose of this study is to determine the safety of a short intravenous infusion of PT-523 to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: PT-523 for Injection |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase I Study of PT-523 in Patients With Solid Tumors |
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | December 2005 |
The primary objectives of this study are 1) to evaluate the safety of a short intravenous infusion of PT-523 when administered on days 1, 8, and 15 of a 28-day cycle to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist; and 2) to establish the maximum tolerated dose (MTD) and identify the dose limiting toxicities (DLT) of PT-523.
The secondary objectives of this study are to determine the pharmacokinetics and to evaluate preliminary efficacy of PT-523.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
There are no limitations on the extent or type of prior therapy received by the patient other than the time intervals indicated above, as long as the patient has demonstrated complete recovery from any adverse effects, and fulfills all relevant inclusion criteria.
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Beth Isreal Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Joseph Paul Eder, M.D. | Dana-Farber Cancer Institute |
More Information
| Study ID Numbers: | 02-000, DFCI Legacy- 03-183, CTEP Grant No.- UO1-CA62490-09, NSC No.- 712783 |
| Study First Received: | July 19, 2004 |
| Last Updated: | March 16, 2007 |
| ClinicalTrials.gov Identifier: | NCT00088023 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Solid tumors |
|
Neoplasms |