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Label indication Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is a microtubule inhibitor indicated for the treatment of: • Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. FDA label
Also known as Abraxane (Induction)
Abraxane · 2 trials · 2 indications
Progression-free survival is defined as the time in months from the date of randomization to the date of disease progression based on the investigator's assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by computerized axial tomography \[CT scan\], not including symptomatic deterioration) or death (any cause) on or prior to 01 Aug 2019. RECIST 1.1 Definition: - Complete response (CR) -disappearance of all target lesions; - Partial response (PR) -at least a 30% decrease in the sum of diameters of target lesions from baseline - Stable disease (SD) -neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase of lesions to qualify for progressive disease (PD) - Progressive Disease (PD) - At least a 20% increase in the sum of diameters of target lesions from nadir, and/or the appearance of new lesions.
| Arm | Type | Description |
|---|---|---|
| Abraxane + Best Supportive Care (BSC) | EXPERIMENTAL | Dosing will occur in two phases - induction and maintenance. During induction, the subject will receive Abraxane plus carboplatin as standard of care. At the end of 4 cycles, if the subject has a complete response, partial response, or stable disease, he/she will continue on to the maintenance phase. Maintenance dosing on this arm includes Abraxane plus best supportive care. |
| Best Supportive Care (BSC) | OTHER | Dosing will occur in two phases - induction and maintenance. During induction, the subject will receive Abraxane plus carboplatin as standard of care. At the end of 4 cycles, if the subject has a complete response, partial response, or stable disease, he/she will continue on to the maintenance phase. Maintenance dosing on this arm includes best supportive care only. |
| Name | Type | Description |
|---|---|---|
| Abraxane (Induction) | DRUG | 100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 and 15 of each 21-day cycle, administered as standard of care |
| Carboplatin (Induction) | DRUG | 6 mg/min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion |
| Abraxane (Maintenance) | DRUG | 100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, administered as standard of care |
| Best Supportive Care (Maintenance) | OTHER | The best palliative care per investigator (including but not limited to: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and/or focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis), excluding antineoplastic agents |
| Abraxane | DRUG | - |
Inclusion Criteria: 1. Age ≥ 18 years of age at the time of signing the Informed Consent Form. 2. Understand and voluntarily provide written consent to the Informed Consent Form prior to conducting any study related assessments/procedures. 3. Able to adhere to the study visit schedule and other pro...
Abraxane is used in oncology for breast cancer, squamous cell carcinoma, and non-small-cell lung cancer. It has been studied as maintenance treatment after Abraxane plus carboplatin in first-line stage IIIB or IV squamous non-small-cell lung cancer, and as adjuvant therapy following Adriamycin plus cyclophosphamide in breast cancer.
Abraxane is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. Bristol-Myers Squibb is the company associated with the clinical development program for Abraxane across the studied cancer indications.
Abraxane is in Phase 1 development according to the program data, with one completed Phase 1 trial in breast cancer. A separate completed Phase 3 trial in squamous non-small-cell lung cancer is also listed. Abraxane is investigational and is not described as approved in this program.
Abraxane has been studied in two completed trials. NCT02027428 was a Phase 3 safety and efficacy study of Abraxane as maintenance treatment after Abraxane plus carboplatin in first-line stage IIIB or IV squamous non-small-cell lung cancer, enrolling 427 patients. NCT00107094 was a Phase 1 study of Adriamycin plus cyclophosphamide followed by Abraxane as adjuvant therapy in breast cancer, enrolling 30 patients.
Yes, Abraxane is also known as Abraxane (Induction). The parenthetical name refers to the same agent, so searches for either term point to the same drug and the same clinical development program.