Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Abraxis BioScience Inc. |
---|---|
Information provided by: | Abraxis BioScience Inc. |
ClinicalTrials.gov Identifier: | NCT00477529 |
To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of ABI-008 given every 3 weeks; to characterize the toxicities of ABI-008; and to determine the pharmacokinetic parameters for ABI-008 when given on an every-3-week schedule.
Condition | Intervention | Phase |
---|---|---|
Hormone Refractory Prostate Cancer |
Drug: ABI-008 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Phase I/II Trial of ABI-008 (Nab-Docetaxel) in Patients With Hormone-Refractory Prostate Cancer |
Estimated Enrollment: | 77 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
ABI-008: Experimental |
Drug: ABI-008
nab-docetaxel
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Each subject must meet the following criteria to be enrolled in this study.
At the time of enrollment, patients must have evidence of progressive metastatic disease, either:
Measurable disease with any level of serum PSA
Patients must have demonstrated evidence of progressive disease since the most recent change in therapy. Progressive disease is defined as any one of the following (measurable disease, bone scan, or PSA progression):
The following restrictions on prior therapy for metastatic disease apply:
Required Initial Laboratory Data:
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from the study.
Contact: Tess Ferrer, RN, BSN | 919-433-8509 | tferrer@abraxisbio.com |
United States, Texas | |
University of Texas M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: John C Araujo, M.D. | |
Principal Investigator: John Araujo, M.D. |
Principal Investigator: | John C Araujo, MD | M.D. Anderson Cancer Center |
Responsible Party: | Abraxis BioScience, LLC ( Tess Ferrer, RN BSN ) |
Study ID Numbers: | CA301 |
Study First Received: | May 21, 2007 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00477529 |
Health Authority: | United States: Food and Drug Administration |
Docetaxel Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |