Osteodex(Osteodex) - 在研适应症：难治性多发性骨髓瘤_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Alendronate/dextran/guanidine、ODX

靶点-

作用方式

抑制剂

作用机制

铁补充剂、破骨细胞抑制剂

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病

在研适应症

难治性多发性骨髓瘤

非在研适应症

骨转移癌去势抵抗性前列腺癌转移性去势抵抗性前列腺癌+ [1]

原研机构

Dextech Medical AB

在研机构

Dextech Medical AB

非在研机构-

权益机构-

最高研发阶段临床1/2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式C4H15NNaO8P2

InChIKeyHZMNHMQPEYMSTG-UHFFFAOYSA-N

CAS号121268-17-5

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关联

4

项与 Osteodex 相关的临床试验

NCT06616389

/ Recruiting临床1/2期

A Phase I/IIa Study of ODX (OsteoDex) in Multiple Myeloma

The current phase I/IIa trial is a multi-center, prospective, open-label, ascending dose study to evaluate safety and biological efficacy of up to 3 dose levels of ODX. Each dose cohort will consist of 4 subjects. Each subject will receive up to 7 doses of ODX, given at 2-week intervals, until unacceptable toxicity or disease progression. A follow-up visit will be conducted 2 weeks after the last dose.
Primary objectives:
• To determine the safety and tolerability of ODX in subjects with relapsed/refractory multiple myeloma.
Secondary objectives:
* To evaluate the preliminary efficacy of ODX, as determined by the IMWG response criteria, in subjects with relapsed/refractory multiple myeloma.
* To evaluate the efficacy of ODX on serum biomarkers (M-protein, FLC, CTX, osteocalcin, and bone-specific S-ALP) in subjects with relapsed/refractory multiple myeloma.
Exploratory objective
• To evaluate time to progression by following M-protein and FLC levels as per clinical routine

开始日期2023-09-05

申办/合作机构

Dextech Medical AB

NCT02825628

/ Completed临床2期

A Randomised, Double-blind, Dose Finding, Repeat Dose Phase II Multicentre Study of ODX for the Treatment of Patients With Castration Resistant Prostate Cancer (CRPC) and Skeletal Metastases

This is a phase II randomised, double-blind, dose finding, repeat dose Phase II multicentre study of ODX for the treatment of patients with castration resistant prostate cancer (CRPC) and skeletal metastases.
The primary objective is to evaluate the relative change from baseline in response markers related to bone metabolism (alkaline phosphatase (B-ALP) and S P1NP) at 12 weeks of three different doses of ODX (3.0, 6.0 and 9.0 mg/kg ODX).

开始日期2016-05-01

申办/合作机构

Dextech Medical AB

NCT02378870

/ Terminated临床2期

A Randomised, Double-blind, Placebo-controlled Multicentre Phase II Study to Evaluate Efficacy and Tolerability of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)

This phase IIb study is a randomized, double-blind, placebo-controlled multi-center study evaluating efficacy and tolerability of Osteodex of patients with metastatic castration resistant prostate cancer (CRPC). Osteodex is a poly-bisphosphonate containing three known substances; dextran, alendronate and guanidine.
The objective of the study is to evaluate the relative change of response markers to bone metabolism (B-ALP and S-P1NP) The following objectives will also be evaluated: overall survival, PSA response, other response markers related to bone metabolism (S-CTX and osteocalcin), safety, tolerability, pain and quality of life.

开始日期2015-01-01

申办/合作机构

Dextech Medical AB

100 项与 Osteodex 相关的临床结果

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100 项与 Osteodex 相关的转化医学

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100 项与 Osteodex 相关的专利（医药）

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87

项与 Osteodex 相关的文献（医药）

2025-06-01·Oncology and Therapy

Oncotype DX Recurrence Score and Germline BRCA Variants in Patients with HR-Positive/HER2-Negative Early Breast Cancer: A Retrospective Observational Study

Article

作者: Luo, Linlin ; Miranda, Miguel ; Lynce, Filipa ; Berrocal-Almanza, Luis C ; Khan, Rabia A ; Partridge, Ann H ; Morganti, Stefania ; Xu, Xiaoqing

INTRODUCTION:

The Oncotype DX (ODX) recurrence score (RS) is prognostic and predictive of chemotherapy benefit in patients with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. Data on the distribution of germline BRCA1 and/or BRCA2 pathogenic variants (gBRCA PV) by RS are limited. This retrospective, real-world study explored demographics, clinical characteristics, gBRCA testing rates, and gBRCA PV prevalence in HR-positive/HER2-negative stage I-III breast cancer, stratified by RS.

METHODS:

Deidentified patient data (from 1 January 2011 to 30 September 2022) from US electronic health records in a nationwide database were used. Patients aged ≥ 18 years with HR-positive/HER2-negative breast cancer and a known ODX RS were included. Demographics, clinical characteristics, and genetic testing rates were compared in patients with low, intermediate, and high tumor RS. gBRCA PV prevalence was compared across categories in patients who underwent genetic testing.

RESULTS:

Of 3637 patients (median age: 62 years), 950 (26.1%) had low, 2155 (59.3%) had intermediate, and 532 (14.6%) had high tumor RS. Despite increases in genetic testing over time, gBRCA status was determined in only 31.5% (n = 1147/3637) of patients. Among tested patients, 37/1147 (3.2%) had gBRCA PV; median age was lower in gBRCA PV carriers than in noncarriers (52 versus 56 years; p = 0.034); tumors from gBRCA PV carriers had significantly higher grade (p = 0.002) and median RS (p = 0.001) than tumors from noncarriers; prevalence of gBRCA PV was highest among tested patients with high tumor RS (n = 14/185; 7.6%), but gBRCA PVs were identified among patients with intermediate (n = 19/674; 2.8%) and low (n = 4/288; 1.4%) tumor RS.

CONCLUSIONS:

Prevalence of gBRCA PV was highest among patients with high tumor RS, but not negligible in patients with intermediate and low tumor RS. Wider implementation of genetic testing, irrespective of ODX RS, could help optimize the management of patients with HR-positive/HER2-negative early breast cancer.

2025-03-01·Cancer Medicine

Nomogram Development for Assessing Oncotype DX Recurrence Scores in Breast Cancer: A Chinese Population Study

Article

作者: Feng, Zhengqi ; Yang, Lin ; Jiang, Liyu ; Song, Jiayin

ABSTRACT:

Background:

Breast cancer (BC) is the most prevalent cancer among women worldwide, with increasing incidence rates, particularly in China. Given the high costs of Oncotype DX (ODX) testing, which predicts recurrence scores (RSs) on the basis of gene expression, developing a nomogram utilizing clinicopathological variables may provide an accessible alternative for risk stratification.

Methods:

We conducted a retrospective analysis of 703 estrogen receptor (ER)‐positive, HER2‐negative T1‐3N0M0 BC patients who underwent ODX testing at Qilu Hospital. A nomogram was developed using multivariate logistic regression to predict low and high RSs in the group. Model performance was validated by receiver operating characteristic curve, calibration curve, and decision curve analysis.

Results:

Multivariate analysis revealed that older age, lower histologic grade, a higher ER expression level, a higher proportion of cells expressing progesterone receptor, and a lower proportion of cells expressing Ki‐67 were significantly associated with a patient being in the low‐risk subgroup. A nomogram was then developed using these variables to predict the RS, with an area under the curve (AUC) of 0.811 (95% confidence interval [CI] = 0.772–0.850) in the development group and 0.794 (95% CI = 0.737–0.851) in the validation group. Calibration and decision curve analyses further confirmed the nomogram's clinical utility. Moreover, a comparison between the TAILORx‐nomogram and our nomogram was conducted, which proved that our nomogram has better predictive accuracy and reliability in Chinese BC patients.

Conclusion:

We present the first nomogram for predicting the RS in Chinese patients with BC on the basis of clinicopathological factors. This model could aid in identifying patients who may not need ODX testing and serve as a cost‐effective alternative for those unable to access ODX, thereby optimizing treatment decisions and enhancing patient management in resource‐limited settings.

2025-01-01·Annals of Surgical Treatment and Research

Characteristics of premenopausal breast cancer patients with a midrange 21-gene recurrence score

Article

作者: Yoon, Chan Seok ; Ahn, Jee Hyun ; Park, Jung Min ; Lee, Suk Jun ; Park, Seho

Purpose:

The results of the TAILORx trial have shown that premenopausal patients with intermediate Oncotype Dx (ODx) recurrence score of 16-25 may benefit from adjuvant chemotherapy. In addition, the clinicopathological features showed the information complementary to ODx results. However, the characteristics may vary depending on menopausal status even in the same score. This study aimed to analyze the differences in the clinical characteristics by menopausal status.

Methods:

This study conducted a retrospective analysis of 756 patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, and node-negative breast cancer who underwent the ODx test from July 2013 to December 2020 at the Severance Hospital.

Results:

Of the 756 patients, 261 patients were postmenopausal, and 495 were premenopausal. The premenopausal patients with a midrange ODx had similar clinicopathological features as compared to those with a high ODx. Conversely, the postmenopausal patients with a midrange ODx did not show significantly different clinicopathological features from those with a low ODx, whereas a difference was seen as compared to those with a high ODx.

Conclusion:

In this study, unlike the postmenopausal patients, some of the clinicopathological characteristics of the premenopausal patients with a midrange ODx were closer to those with a high ODx than those with a low ODx. In the premenopausal patients with a midrange ODx, considering the baseline characteristic itself, there was a significant difference between those with a low ODx when compared with postmenopausal patients. Therefore, more aggressive treatment decisions may be helpful in premenopausal patients with a midrange ODx.

100 项与 Osteodex 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
难治性多发性骨髓瘤	临床2期	瑞典	Dextech Medical AB	2023-09-05
骨转移癌	临床2期	爱沙尼亚	Dextech Medical AB	2016-05-01
骨转移癌	临床2期	芬兰	Dextech Medical AB	2016-05-01
骨转移癌	临床2期	拉脱维亚	Dextech Medical AB	2016-05-01
骨转移癌	临床2期	瑞典	Dextech Medical AB	2016-05-01
去势抵抗性前列腺癌	临床2期	爱沙尼亚	Dextech Medical AB	2016-05-01
去势抵抗性前列腺癌	临床2期	芬兰	Dextech Medical AB	2016-05-01
去势抵抗性前列腺癌	临床2期	拉脱维亚	Dextech Medical AB	2016-05-01
转移性去势抵抗性前列腺癌	临床2期	瑞典	Dextech Medical AB	2015-01-01
转移性前列腺癌	临床2期	瑞典	Dextech Medical AB	2015-01-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02825628 (Pubmed)	临床2期	去势抵抗性前列腺癌 bone alkaline phosphatase (B-ALP) \| serum-aminoterminal-propeptide of Type I procollagen (S-P1NP) \| serum C-terminal telopeptide	55	ODX 3 mg/kg	窪範膚鏇鏇淵艱壓積繭(鏇窪積選餘鹹積簾願憲) = 鹹淵窪襯淵網鏇憲夢築顧鹽蓋襯襯糧廠積憲壓 (選網衊範遞艱網糧夢築 )	-	2023-03-01
				ODX 6 mg/kg	窪範膚鏇鏇淵艱壓積繭(鏇窪積選餘鹹積簾願憲) = 蓋鑰餘廠鹹齋積壓鹽鹽顧鹽蓋襯襯糧廠積憲壓 (選網衊範遞艱網糧夢築 )