Nanoxel M (docetaxel polymeric micelle) / Samyang Group - LARVOL DELTA

Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer (clinicaltrials.gov) - P3 | N=26 | Terminated | Sponsor: Samyang Biopharmaceuticals Corporation | N=320 ➔ 26 | Trial completion date: Dec 2024 ➔ May 2024 | Recruiting ➔ Terminated; The Decision to Terminate Early Due to Difficulties in Recruiting Participants and Conducting the Study.

Enrollment change • Trial completion date • Trial termination • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Compare the Efficacy and the Safety of Doxorubicin and Cyclophosphamide Followed by Taxotere Versus Doxorubicin and Cyclophosphamide Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer (clinicaltrials.gov) - P3 | N=320 | Recruiting | Sponsor: Samyang Biopharmaceuticals Corporation | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jun 2023 ➔ Mar 2024

Enrollment open • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

A phase 2 multicenter study of docetaxel-PM and trastuzumab-pkrb combination therapy in recurrent or metastatic salivary gland carcinomas. (PubMed, Cancer) - "Salivary duct carcinoma (SDC) is uncommon but is the most aggressive subtype of salivary gland carcinomas. SDC shares morphological and histological similarities with invasive ductal carcinoma of breast, which led to an investigation of hormonal receptor and human epidermal growth factor receptor 2 (HER2)/neu expression status in SDC. In this study, patients with HER2-positive SDC were enrolled and treated with combination of docetaxel-polymeric micelle and trastuzumab-pkrb. Promising antitumor activities were shown with objective response rate of 69.8%, disease control rate of 93.0%, median progression-free survival of 7.9 months, median duration of response of 6.7 months, and median overall survival of 23.3 months."

Clinical • Combination therapy • Journal • Metastases • P2 data • Breast Cancer • Head and Neck Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Salivary Gland Cancer • Solid Tumor • HER-2

Hypoxia-Responsive Stereocomplex Polymeric Micelles with Improved Drug Loading Inhibit Breast Cancer Metastasis in an Orthotopic Murine Model. (PubMed, ACS Appl Mater Interfaces) - "Taxane-loaded polymeric formulations, such as Genexol PM and Nanoxel M using poly(ethylene glycol)-poly(d,l-lactide) (PEG-PLA) micelles as drug carriers, have been approved for the treatment of metastatic breast cancer. In vivo results further showed that the micelles, especially at a high dose, inhibited the growth of the primary tumor and improved tumor pathological conditions, consequently remarkably inhibiting its metastasis to the lungs and liver, while not causing any systemic toxicity. Hypoxia-responsive stereocomplex micelles thus emerge as a reliable drug delivery system to treat breast cancer metastasis."

Journal • Preclinical • Breast Cancer • Oncology • Solid Tumor

Compare the Efficacy and the Safety of Doxorubicin and Cyclophosphamide Followed by Taxotere Versus Doxorubicin and Cyclophosphamide Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer (clinicaltrials.gov) - P3; N=320; Not yet recruiting; Sponsor: Samyang Biopharmaceuticals Corporation

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • MRI • PGR

Study to Evaluate the Safety of Nanoxel M Inj. (clinicaltrials.gov) - P=N/A; N=1498; Recruiting; Sponsor: Samyang Biopharmaceuticals Corporation; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC (clinicaltrials.gov) - P3; N=36; Terminated; Sponsor: Samyang Biopharmaceuticals Corporation; N=88 ➔ 36; Recruiting ➔ Terminated

Clinical • Enrollment change • Trial termination

Study to Evaluate the Safety of Nanoxel M Inj. (clinicaltrials.gov) - P; N=1498; Not yet recruiting; Sponsor: Samyang Biopharmaceuticals Corporation

Clinical • New trial