Clinical Trials

Abraxis BioScience has a robust active clinical trials program that is investigating the use of ABI-007 (nab-paclitaxel) in breast cancer, lung cancer, and melanoma. Abraxis is also conducting clinical trials with several other promising oncology and cardiovascular drug candidates.

Abraxis BioScience posts protocol information for all ongoing Phase II, III, and IV trials to the National Institutes of Health's (NIH) ClinicalTrials.gov web site. To learn more about the Abraxis BioScience clinical trials that are under way or to find out if a study is enrolling patients in your area, please visit www.clinicaltrials.gov.

If you have a specific question regarding Abraxis BioScience products and technologies, please contact Medical Information at 1.800.564.0216, option #2.

Patients interested in learning more about participation in ongoing clinical trials should speak with their doctor or nurse to determine treatment options that are most appropriate to their illness. The information found in this section is not intended to replace conversations with your health care team.

nab™-paclitaxel in Breast Cancer Clinical Trials

Trial 012: a multinational, randomized phase III trial of nab™-paclitaxel (ABI-007) vs standard solvent-based paclitaxel (paclitaxel injection) for the treatment of metastatic breast cancer¹⁷*

*This trial is closed and has been published in the Journal of Clinical Oncology: 2005;23:7794-7803.

Trial 024: a phase II trial of nab™-paclitaxel (ABI-007) vs docetaxel as first-line therapy for metastatic breast cancer^16†

^†This trial is ongoing, yet closed to accrual of new patients.

Trial 048: a randomized phase III study of weekly ABI-007 vs every 3 weeks docetaxel as first-line therapy of stage IV (metastatic) breast cancer^‡

•  Confirmed stage IV adenocarcinoma of the breast •  No prior chemotherapy for metastatic disease •  Eastern Cooperative Oncology Group (ECOG) performance status 0-2 •  Peripheral neuropathy ≤ grade 1	•  Prior adjuvant taxane therapy completed less than 1 year before enrollment •  HER2-positive patients •  Parenchymal brain metastases, unless stable for at least 6 months after treatment •  Hypersensitivity to either paclitaxel or docetaxel

^‡This trial is planned to be initiated in 2007.

Ongoing Trials in Breast Cancer and Other Tumor Types

Trial 031: a randomized phase III trial of ABI-007 and carboplatin compared with standard solvent-based paclitaxel and carboplatin as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC)^§

•  Stage IIIB or IV NSCLC •  No prior chemotherapy for metastatic disease •  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 •  Expected survival of ≥12 weeks	•  Preexisting ≥grade 2 peripheral neuropathy •  History of allergy or hypersensitivity to study drugs •  Radiotherapy or exposure to an investigational drug in the previous 4 weeks •  Active brain metastases

^§This trial is planned to be initiated in 2007.

Trial 033: an open-label, multicenter phase III trial of ABI-007 vs dacarbazine in previously untreated patients with metastatic malignant melanoma^||

•  Confirmed stage IV malignant melanoma •  No prior chemotherapy for metastatic disease •  Eastern Cooperative Oncology Group (ECOG) performance status 0-1 •  Expected survival of >12 weeks	•  Pre-existing peripheral neuropathy ≥grade 2 •  History or current evidence of brain metastases •  Prior radiation to a target lesion

^||This trial is planned to be initiated in 2007.