Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Albumin-bound paclitaxel · 4 trials · 3 indications
Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods.
Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response \[CR\] or Partial Response \[PR\]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. A complete response was defined as a disappearance of all target and non-target lesions and no new lesions. Partial response was defined as ≥ 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, and the persistence of one or more non-target lesions not qualifying for CR or Progressive Disease (the "unequivocal progression" of existing non-target lesion(s) or appearance of one or more new lesions).
Percentage of participants who achieved 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 confirmed at least 4 weeks after initial documentation. A partial response (PR) is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing, or with the persistence of one or more non-target lesions and/or the maintenance of tumor marker level above the normal limits.
A dose-limiting toxicity (DLT) is defined as one or more of the following toxicities related to study drug during Cycle 1, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3: * Grade 4 neutropenia lasting \>3 days in the absence of growth factor support; * Grade 4 neutropenia associated with fever \>38.5°C; * Any other Grade 4 hematological toxicity; * Grade 3 thrombocytopenia with hemorrhage; * Grade 3 or 4 nausea, vomiting or diarrhea despite prophylaxis or treatment with an optimal anti-emetic or anti-diarrhea regimen; * Any other Grade 3 or higher non-hematological toxicity attributable to the study drug, excluding alopecia and fatigue.
| Arm | Type | Description |
|---|---|---|
| Albumin-bound paclitaxel (ABI-007)/Gemcitabine | EXPERIMENTAL | ABI-007 125 mg/m2 administered in combination with gemcitabine 1000 mg/m2 weekly for 3 weeks followed by one week of rest. |
| Gemcitabine | ACTIVE_COMPARATOR | Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward). |
| Albumin-bound paclitaxel + Carboplatin | EXPERIMENTAL | Participants received albumin-bound paclitaxel (ABRAXANE®) 100 mg/m\^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent. |
| Paclitaxel + Carboplatin | ACTIVE_COMPARATOR | Participants received 200 mg/m\^2 paclitaxel (Taxol®) administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21 day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent. |
| Albumin-bound paclitaxel, Carboplatin + Herceptin | EXPERIMENTAL | Participants received albumin-bound paclitaxel, 100 mg/m\^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment. |
| 100 mg/m^2 | EXPERIMENTAL | Participants received albumin-bound paclitaxel 100 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity. |
| 125 mg/m^2 | EXPERIMENTAL | Participants received albumin-bound paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity. |
| 150 mg/m^2 | EXPERIMENTAL | Participants received albumin-bound paclitaxel 150 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Albumin-bound paclitaxel (ABI-007) | DRUG | ABI-007 125 mg/m\^2 administered by intravenous infusion |
| Gemcitabine | DRUG | Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward). |
| Albumin-bound paclitaxel | DRUG | Administered by intravenous infusion. |
| Paclitaxel | DRUG | Administered by intravenous infusion. |
| Carboplatin | DRUG | Administered by intravenous infusion. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25). For the purposes of this protocol, the GFR is considered to be equivalent to creatinine clearance (calculated by the method of Cockcroft and Gault, 1976). |
| Herceptin® | DRUG | Administered by IV infusion |
Inclusion Criteria A participant will be eligible for inclusion in this study only if all of the following criteria are met: 1. Participant has definitive histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocar...
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Albumin-bound paclitaxel is used for breast cancer, non-small cell lung carcinoma, and metastatic pancreatic cancer. It is an oncology small molecule being developed by Bristol-Myers Squibb Company (BMY). Clinical trials have studied it in advanced breast cancer, advanced non-small cell lung cancer, and metastatic pancreatic cancer.
Albumin-bound paclitaxel is a small molecule that targets microtubules. It is being studied in oncology for breast cancer, non-small cell lung carcinoma, and metastatic pancreatic cancer. The drug is in clinical development for these indications.
Albumin-bound paclitaxel is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials of the drug in oncology indications including breast cancer, non-small cell lung carcinoma, and metastatic pancreatic cancer.
Albumin-bound paclitaxel is in Phase 2 clinical development. It has been studied in completed trials, including Phase 1, Phase 2, and Phase 3 studies, across breast cancer, non-small cell lung carcinoma, and metastatic pancreatic cancer. The drug remains investigational.
Albumin-bound paclitaxel has been studied in completed trials including NCT00093145 for advanced breast cancer, NCT00398086 for metastatic pancreatic cancer, NCT00540514 for advanced non-small cell lung cancer, and NCT00844649 for metastatic pancreatic cancer. These trials are all completed.
Albumin-bound paclitaxel is also known as Abraxane and ABI-007. Clinical trial titles refer to albumin-bound paclitaxel (Abraxane) and ABI-007 (albumin-bound paclitaxel). These names refer to the same drug being studied in oncology indications.