Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational oncology drug being studied for the treatment of breast cancer and squamous cell carcinoma of the non-small-cell lung. It is a small molecule therapeutic developed by Bristol-Myers Squibb Company (BMY). Clinical trials have evaluated its use as adjuvant therapy for breast cancer and as maintenance treatment after first-line therapy for stage IIIB/IV squamous cell non-small-cell lung cancer.
Abraxane is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research on this oncology drug for indications including breast cancer and squamous cell carcinoma of the non-small-cell lung. Bristol-Myers Squibb is responsible for the drug's development program.
Abraxane is in clinical development, with trials listed in Phase 1 and Phase 3. One completed Phase 1 trial studied the drug as adjuvant therapy for breast cancer, and one completed Phase 3 trial evaluated it as maintenance treatment for squamous cell non-small-cell lung cancer. The drug remains investigational and is not approved.
Abraxane has been studied in two completed clinical trials. NCT00107094 was a Phase 1 study of Adriamycin plus cyclophosphamide followed by Abraxane as adjuvant therapy for breast cancer, enrolling 30 female patients in the United States. NCT02027428 was a Phase 3 study of Abraxane as maintenance treatment after Abraxane plus carboplatin in first-line stage IIIB/IV squamous cell non-small-cell lung cancer, enrolling 427 patients across multiple countries.
Abraxane is a small molecule therapeutic, but its specific molecular target has not been disclosed in the available information. The drug is being investigated for its potential role in treating breast cancer and squamous cell carcinoma of the non-small-cell lung, based on its mechanism of action as an oncology agent.