Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Abraxis BioScience Inc. |
---|---|
Information provided by: | Abraxis BioScience Inc. |
ClinicalTrials.gov Identifier: | NCT00820768 |
To determine MTD and DLT of ABI-010 given weekly every three weeks followed by one week of rest (Cycle 1). Determine MLD and DLT in combination with ABI-007; to characterize the toxicities of ABI-010 alone and in combination with ABI-007.
Condition | Intervention | Phase |
---|---|---|
Solid Tumor |
Drug: ABI-010 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | A Phase I of ABI-010 (Nab-17-AAG) and ABI-007 (Abraxane) Administered Weekly in Patients With Advanced Non-Hematologic Malignancies |
Estimated Enrollment: | 42 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
ABI-010: Experimental |
Drug: ABI-010
17-AAG and ABI-007
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: Each subject must meet the following criteria to be enrolled in this study:
Patient must have the following blood counts at Baseline:
Patient must have the following blood chemistry levels at Baseline:
Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from the study.
Responsible Party: | Abraxis BioScience, LLC ( Tess Ferrer, RN, BSN ) |
Study ID Numbers: | CA501 |
Study First Received: | January 9, 2009 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00820768 |
Health Authority: | United States: Food and Drug Administration |
Paclitaxel |