Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nanoparticle Paclitaxel · 1 trial · 1 indication
Toxicities were evaluated based on the U.S. National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events version 3.0. Any drug-related toxicities considered CTC Grade 3 or 4 were considered dose limiting. The maximum tolerated dose was defined as the lesser of 45 mg/m\^2 or the dose at which any drug related toxicities were observed.
Procedural complications include the following: 1. Haemodynamic monitoring: changes in heart rate, arterial blood pressure or electrocardiogram changes; 2. Arrhythmia: premature ventricular complexes, brady or tachyarrhythmia; 3. Allergic reactions: rash, flushing, pyrexia, urticaria, angio-oedema; 4. Angiographic complications: coronary artery spasm, dissection, thrombosis, TIMI (Thrombolysis In Myocardial Infarction) flow, no reflow; 5. Clinical changes: chest pain.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. An SAE is any event that: * is fatal or life threatening * results in persistent or significant disability or or incapacity; * requires or prolongs existing hospitalization; * is a congenital anomaly/birth defect in the offspring of a patient who received medication; * conditions not included above that may jeopardize the patient or require intervention to prevent one of the outcomes listed above.
Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion.
Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion.
| Arm | Type | Description |
|---|---|---|
| 10 mg/m^2 nanoparticle paclitaxel | EXPERIMENTAL | Participants received a single dose of 10 mg/m\^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions). |
| 22 mg/m^2 nanoparticle paclitaxel | EXPERIMENTAL | Participants received a single dose of 22 mg/m\^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions). |
| 35 mg/m^2 nanoparticle paclitaxel | EXPERIMENTAL | Participants received a single dose of 35 mg/m\^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions). |
| 45 mg/m^2 nanoparticle paclitaxel | EXPERIMENTAL | Participants received a single dose of 45 mg/m\^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions). |
| Name | Type | Description |
|---|---|---|
| Nanoparticle Paclitaxel | DRUG | Nanoparticle albumin-bound paclitaxel, administered via intracoronary catheter. |
Inclusion Criteria: * Male or non-pregnant and non-lactating female, and ≥ 18 years of age. * Diagnosis of angina pectoris or unstable angina pectoris or patients with documented silent ischemia. * Left ventricular ejection fraction ≥30% * Patient has undergone successful and uncomplicated stenting...
Nanoparticle Paclitaxel is an investigational small molecule being studied for the prevention of coronary restenosis, a condition where a previously treated coronary artery narrows again. It is being developed by Bristol-Myers Squibb Company (BMY) and is currently in Phase 1 clinical development.
Nanoparticle Paclitaxel is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. The drug is an investigational small molecule intended for the prevention of coronary restenosis.
Nanoparticle Paclitaxel is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial for the prevention of coronary restenosis has been completed.
Nanoparticle Paclitaxel has one completed clinical trial, NCT00124943, titled 'Use of Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis.' This Phase 1 study enrolled 112 participants with coronary restenosis and was a randomized, controlled trial.
Yes, Nanoparticle Paclitaxel is also known as ABI-007. The completed clinical trial NCT00124943 refers to the drug as ABI-007 in its title, confirming that these names refer to the same investigational agent being studied for coronary restenosis.