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DRUG:

Nanoxel M (docetaxel polymeric micelle)

i
Other names: B 5704, SYP-0704A
Associations
Trials
Company:
Samyang Group
Drug class:
Tubulin polymerization promoter, Microtubule stabilizer
Associations
Trials
7ms
Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer (clinicaltrials.gov)
P3, N=26, Terminated, 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
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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HER-2 positive • HER-2 negative
|
cyclophosphamide • Nanoxel M (docetaxel polymeric micelle)
10ms
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, Samyang Biopharmaceuticals Corporation | Not yet recruiting --> Recruiting | Trial primary completion date: Jun 2023 --> Mar 2024
Enrollment open • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 positive • HER-2 negative
|
cyclophosphamide • Nanoxel M (docetaxel polymeric micelle)
over1year
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 • P2 data • Journal • Combination therapy • Metastases
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HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive • HER-2 expression
|
Herzuma (trastuzumab-pkrb) • Nanoxel M (docetaxel polymeric micelle) • SIBP-01 (trastuzumab biosimilar)
almost3years
New P3 trial
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 positive • HER-2 negative
|
doxorubicin hydrochloride • cyclophosphamide • Nanoxel M (docetaxel polymeric micelle)