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Sponsored by: |
Abraxis BioScience Inc. |
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Information provided by: | Abraxis BioScience Inc. |
ClinicalTrials.gov Identifier: | NCT00635284 |
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-009 given weekly; to characterize the toxicities of ABI-009; and to determine the pharmacokinetic parameters for ABI-009 when given on a weekly schedule.
Condition | Intervention | Phase |
---|---|---|
Solid Tumors |
Drug: ABI-009 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Phase I Trial of ABI-009 (Nab-rapamycin) Administered Weekly in Patients With Advanced Non-hematologic Malignancies |
Estimated Enrollment: | 42 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
ABI-009: Experimental |
Drug: ABI-009
nab-rapamycin
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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.
Required Initial Laboratory Data:
Adequate renal function with serum creatinine < 1.5 mg/dL and/or creatinine clearance (cockroft formula)
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, California | |
Sarcoma Oncology Center | Recruiting |
Santa Monica, California, United States, 90403 | |
Contact: Viky Chua 310-552-9999 | |
Principal Investigator: Sant P. Chawla, MD | |
United States, Texas | |
University of Texas M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Ana M Gonzalez, MD | |
Principal Investigator: Ana M Gonzalez, MD |
Principal Investigator: | Ana M. Gonzalez, MD | M.D. Anderson Cancer Center |
Principal Investigator: | Sant P. Chawla, MD | Sarcoma Oncology Center |
Responsible Party: | Abraxis BioScience, LLC ( Tess Ferrer, RN, BSN ) |
Study ID Numbers: | CA401 |
Study First Received: | March 7, 2008 |
Last Updated: | September 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00635284 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Sirolimus Anti-Infective Agents Anti-Bacterial Agents |
Immunologic Factors Antifungal Agents Immunosuppressive Agents |
Sirolimus Anti-Bacterial Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Antifungal Agents |
Therapeutic Uses Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |