Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABI-007 · 10 trials · 10 indications
PFS was defined as the time from the randomization date to the start of disease progression or patient death, whichever occurred first. Participants who did not have disease progression or had not died were censored at the last known time that the patient was progression free. In the event of palliative radiotherapy or surgery, they were censored at the last assessment where they were documented to be progression-free prior to the date of radiotherapy or surgery. In follow up, participants who began new anticancer therapy prior to documented progression were censored at the last assessment where they were documented as progression free. Those with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where they were documented to be progression free. RECIST defines progressive disease as a ≥ 20% increase taking as reference the smallest sum of the longest diameters recorded since the treatment began.
PFS rate was measured by Investigator Assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 from the start of study treatment to disease progression or death from any cause, whichever occurred first.
Count of study participants who had at least one treatment-emergent adverse event (TEAE) defined as any adverse event that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug.
Progression-free survival is defined as the time from first dose of study drug to the start of disease progression or patient death, whichever occurs first. Patients who do not have disease progression or have not died at the end of follow-up were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Response Evaluation Criteria in Solid Tumors (RECIST) defines progressive disease (PD) as a \>= 20% increase taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.
Percentage of participants who achieve an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms. A partial response (PR) is \>= 30% decrease in the sum of the longest diameters of target lesion. PR was also recorded when all measurable disease has completely disappeared, but a non-measurable component (ie, ascites) is still present but not progressing. Overall response (ORR) = CR+PR.
| Arm | Type | Description |
|---|---|---|
| ABI-007 | EXPERIMENTAL | Treatment Arm A (ABI-007): Patients who receive ABI-007 will be dosed intravenously over approximately 30 minutes without steroid pre-medication and without G-CSF prophylaxis (unless modified as described below). ABI-007 150 mg/m2 will be administered on Days 1, 8, and 15 every 4 weeks. |
| Dacarbazine | ACTIVE_COMPARATOR | Treatment Arm B (dacarbazine): Patients who receive dacarbazine will be dosed intravenously at 1000 mg/m2 on Day 1 with steroid and antiemetic pre-medication. Treatment will be repeated every 21 days. |
| Abraxane (nab®paclitaxel) | EXPERIMENTAL | Abraxane (nab®paclitaxel) 125 milligrams per meter squared on days 1, 8 and 15 of a 28 day cycle |
| ABI-007 plus Bevacizumab | EXPERIMENTAL | ABI-007 is administered on days 1, 8 and 15 at 125 mg/m\^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient. |
| ABI-007 300 mg/m^2 q3w | EXPERIMENTAL | ABI-007 300 mg/m\^2 administered once every third week (q3w). |
| ABI-007 100 mg/m^2 weekly | EXPERIMENTAL | ABI-007 100 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest |
| ABI-007 150 mg/m^2 weekly | EXPERIMENTAL | ABI-007 150 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest |
| Docetaxel 100 mg/m^2, q3w | ACTIVE_COMPARATOR | Docetaxel (Taxotere) 100 mg/m\^2 administered once every third week (q3w). |
| ABI-007 and Carboplatin | EXPERIMENTAL | ABI-007 and Carboplatin in patients with Advanced Non-Small Cell Lung Cancer. |
| Name | Type | Description |
|---|---|---|
| ABI-007 | DRUG | Patients who receive ABI-007 will be dosed intravenously over approximately 30 minutes without steroid pre-medication and without G-CSF prophylaxis (unless modified as described below). ABI-007 150 mg/m2 will be administered on Days 1, 8, and 15 every 4 weeks. |
| Dacarbazine | DRUG | Patients who receive dacarbazine will be dosed intravenously at 1000 mg/m2 on Day 1 with steroid and antiemetic pre-medication. Treatment will be repeated every 21 days. |
| Bevacizumab | DRUG | Bevacizumab administered once every 2 weeks (10 mg/kg) by IV infusion after ABI-007 has been given. The first dose is one Day 1, cycle 1. |
| Docetaxel | DRUG | Docetaxel dosed q3w at 100 mg/m\^2 |
| ABI-007 (Abraxane) and Carboplatin | DRUG | ABI-007 plus Carboplatin will be administered intravenously over 30 minutes in cycles of 3 weeks |
Inclusion Criteria: * Histologically or cytologically confirmed cutaneous malignant melanoma with evidence of metastasis (Stage IV). * No prior cytotoxic chemotherapy for metastatic malignant melanoma is permitted. Prior treatment with kinase inhibitors or cytokines is permitted. * No prior adjuvan...
ABI-007 is an investigational oncology drug also known as Abraxane, a small molecule studied in breast neoplasms, colorectal neoplasms, malignant melanoma, and metastatic breast cancer. It is being developed by Bristol-Myers Squibb Company (BMY). The program has completed Phase 3 and Phase 2 clinical trials.
ABI-007 has been studied for the treatment of several cancers, including metastatic breast cancer, colorectal neoplasms, and malignant melanoma. It is an investigational agent and has been evaluated in clinical trials for these indications. It is not described as approved for any use in the available information.
ABI-007 is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is responsible for the clinical development program of ABI-007 across the studied cancer indications.
ABI-007 has completed Phase 3 clinical development. The program includes a Phase 3 trial and multiple Phase 2 trials, all of which are completed. No active trials are ongoing. It is an investigational drug and is not described as FDA approved.
ABI-007 has been evaluated in completed trials including NCT00864253, a Phase 3 study in metastatic malignant melanoma; NCT02103062, a Phase 2 study in metastatic colorectal cancer; NCT00394082, a Phase 2 study in metastatic breast cancer; and NCT00274456, a Phase 2 study in stage IV breast cancer.
Yes, ABI-007 is also known as Abraxane. The names ABI-007 and Abraxane refer to the same investigational drug. It has also been studied in combination with carboplatin, referred to as ABI-007 and carboplatin.