- |||||||||| Ixempra (ixabepilone) - Otsuka, R / Pharm, Allarity Therap, patupilone (EPO 906) / Novartis
Trial termination: Ixabepilone to Treat Cervical Cancer (clinicaltrials.gov) - Nov 21, 2019
P2, N=41, Terminated,
Completed --> Terminated; Premature closure due to slow/insufficient accrual.
- |||||||||| Zolinza (vorinostat) / Merck (MSD), Ixempra (ixabepilone) - Otsuka, R / Pharm, Allarity Therap
Trial completion, Trial completion date, Metastases: Ixabepilone and Vorinostat in Treating Patients With Metastatic Breast Cancer (clinicaltrials.gov) - Nov 15, 2019
P1, N=56, Completed,
Completed --> Terminated; Premature closure due to slow/insufficient accrual. Active, not recruiting --> Completed | Trial completion date: Jun 2020 --> Sep 2019
- |||||||||| Ixempra (ixabepilone) - Otsuka, R / Pharm, patupilone (EPO 906) / Novartis
Journal: Epothilone B Benefits Nigrostriatal Pathway Recovery by Promoting Microtubule Stabilization After Intracerebral Hemorrhage. (Pubmed Central) - Sep 28, 2019
In conclusion, EpoB treatment may have therapeutic utility for improving corneal reinnervation and restoring sensitivity following corneal injury. Our results clarified the pathomorphological changes of the nigrostriatal pathway after ICH and found that epothilone B helped alleviate nigrostriatal pathway injury after ICH, associated with promoting α-tubulin acetylation to maintain microtubule stabilization, thus facilitating motor recovery.
- |||||||||| Halaven (eribulin mesylate) / Eisai, vinorelbine tartrate / Generic mfg.
Eribulin treatment activates type 1 IFNs to promote a gene expression signature associated with antitumor immunity (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_798;
We evaluated the effects of 5 distinct MTAs used for the treatment of TNBC, paclitaxel, docetaxel, ixabepilone, vinorelbine, and eribulin, on the expression of antitumor cytokines and other immunomodulatory genes in myeloid and in TNBC cells...A nanoparticle-incorporated STING activator enhances antitumor immunity in PD-L1-insensitive models of triple-negative breast cancer. JCI Insight 3 , (2018).
- |||||||||| Ixempra (ixabepilone) - Otsuka, R / Pharm, patupilone (EPO 906) / Novartis
Journal: Yield improvement of epothilones in Burkholderia strain DSM7029 via transporter engineering. (Pubmed Central) - Sep 8, 2019
Hence, we strongly recommend that the Orf14 and Orf3 transporters export epothilone, thus promotes the forward reaction of biosynthesis on epothilone manufacture inside the cells. Our results afford a practical stage for yield improvement of other heterologous natural products in broad chassis cells.
- |||||||||| Zolinza (vorinostat) / Merck (MSD), Ixempra (ixabepilone) - Otsuka, R / Pharm, Allarity Therap
Trial completion date, Metastases: Ixabepilone and Vorinostat in Treating Patients With Metastatic Breast Cancer (clinicaltrials.gov) - Sep 3, 2019
P1, N=56, Active, not recruiting,
Our results afford a practical stage for yield improvement of other heterologous natural products in broad chassis cells. Trial completion date: Jun 2019 --> Jun 2020
- |||||||||| Ixempra (ixabepilone) - Otsuka, R / Pharm, Thalomid (thalidomide) / Celgene, Fujimoto Pharma
Review, Journal: Mechanisms of Chemotherapy-Induced Peripheral Neuropathy. (Pubmed Central) - Jul 19, 2019
This paper reviews the clinical picture of CIPN and the neurotoxicity mechanisms of the most common antineoplastic agents. A better understanding of the risk factors and underlying mechanisms of CIPN is needed to develop effective preventive and therapeutic strategies.
- |||||||||| Ixempra (ixabepilone) - Otsuka, R / Pharm, patupilone (EPO 906) / Novartis
Journal: Synthesis, anticancer activity and cytotoxicity of galactosylated epothilone B. (Pubmed Central) - Jun 26, 2019
It indicated that the ratio of cytotoxicity between the free epothilone B and the galactosylated epothilone B was about 150. This would lay the foundation for the targeted treatment of cancer with epothilone glycosides.
- |||||||||| Biomarker, Review, Journal, BRCA Biomarker, PARP Biomarker, PD(L)-1 Biomarker, IO Biomarker: How I treat metastatic triple-negative breast cancer. (Pubmed Central) - Jun 25, 2019
In patients with a high disease burden or who are very symptomatic, combinations such as anthracyclines plus cyclophosphamide or platins with taxanes are valid options...For patients who progressed to taxanes and anthracyclines, or who present contraindications to these agents, fluorouracil/capecitabine, eribulin, gemcitabine, cisplatin/carboplatin, vinorelbine and ixabepilone are alternatives. The treatment of TNBC is constantly evolving, and the inclusion of patients in ongoing trials evaluating new targeted agents, immunotherapy and predictive biomarkers should be encouraged, in an attempt to improve metastatic TNBC treatment outcomes.
- |||||||||| Ixempra (ixabepilone) - Otsuka, R / Pharm, Halaven (eribulin mesylate) / Eisai
Biomarker, Enrollment open, Trial completion date, Trial primary completion date, Biopsy: Pharmacodynamic Biomarkers of Standard Anti-microtubule Drugs as Assessed by Early Tumor Biopsy (clinicaltrials.gov) - Mar 19, 2019
P=N/A, N=35, Recruiting,
This combination is a reasonable option for those patients with MBC who require combination chemotherapy. Suspended --> Recruiting | Trial completion date: Feb 2019 --> Jun 2021 | Trial primary completion date: Feb 2019 --> Jun 2020
- |||||||||| Ixempra (ixabepilone) - Otsuka, R / Pharm, Allarity Therap
Trial withdrawal, Metastases: Ixabepilone and SBRT For Metastatic Breast Cancer (clinicaltrials.gov) - Jan 9, 2019
P2, N=0, Withdrawn,
N=54 --> 1 | Recruiting --> Terminated; Overlapping study, PI preferred to enroll in alternate trial. Terminated --> Withdrawn
- |||||||||| Ixempra (ixabepilone) - Otsuka, R / Pharm, Allarity Therap
Trial completion, Phase classification, Metastases: Ixabepilone and Ketoconazole in Treating Patients With Advanced Solid Tumors (clinicaltrials.gov) - Oct 31, 2018
P1, N=29, Completed,
Trial primary completion date: Feb 2017 --> Jun 2018 Active, not recruiting --> Completed | Phase classification: P1/2 --> P1
- |||||||||| Ixempra (ixabepilone) - Otsuka, R / Pharm, Allarity Therap, Avastin (bevacizumab) / Roche
Trial completion date, Trial primary completion date: Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab (clinicaltrials.gov) - Oct 31, 2018
P2, N=88, Recruiting,
Active, not recruiting --> Completed | Phase classification: P1/2 --> P1 Trial completion date: Mar 2022 --> Feb 2026 | Trial primary completion date: Mar 2019 --> Feb 2021
- |||||||||| Zolinza (vorinostat) / Merck (MSD), Ixempra (ixabepilone) - Otsuka, R / Pharm, Allarity Therap
P1 data, Journal: Phase IB trial of ixabepilone and vorinostat in metastatic breast cancer. (Pubmed Central) - Oct 21, 2018
This drug combination offers a novel therapy for previously treated MBC patients. The potential for lower toxicity and comparable efficacy compared to current therapies warrants further study.
- |||||||||| Onzeald (etirinotecan pegol) / Nektar Therap
Enrollment change, Trial completion date, Trial primary completion date, Metastases: ATTAIN: A Study of Etirinotecan Pegol (NKTR-102) Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine (clinicaltrials.gov) - Aug 28, 2018
P3, N=220, Recruiting,
Active, not recruiting --> Completed N=350 --> 220 | Trial completion date: Feb 2020 --> Mar 2021 | Trial primary completion date: Aug 2019 --> Jul 2020
- |||||||||| Ixempra (ixabepilone) - Otsuka, R / Pharm, Allarity Therap, Avastin (bevacizumab) / Roche, Torisel (temsirolimus) / Pfizer
Biomarker, P2 data, Clinical Trial,Phase I, Clinical Trial,Phase II, Journal: A phase II study of frontline paclitaxel/carboplatin/bevacizumab, paclitaxel/carboplatin/temsirolimus, or ixabepilone/carboplatin/bevacizumab in advanced/recurrent endometrial cancer. (Pubmed Central) - Aug 15, 2018
PFS was not significantly increased in any experimental arm compared to historical controls. NRG Oncology/Gynecologic Oncology Group Study GOG-86P.
- |||||||||| Ixempra (ixabepilone) - Otsuka, R / Pharm, Allarity Therap, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Trial completion date, Trial primary completion date: Neo-Adjuvant Study in Triple Negative Breast Cancer Patients (clinicaltrials.gov) - Jul 26, 2018
P2, N=40, Active, not recruiting,
NRG Oncology/Gynecologic Oncology Group Study GOG-86P. Trial completion date: Dec 2016 --> Dec 2019 | Trial primary completion date: Dec 2016 --> Dec 2019
- |||||||||| Zolinza (vorinostat) / Merck (MSD), Ixempra (ixabepilone) - Otsuka, R / Pharm, Allarity Therap
Trial completion date, Trial primary completion date, Metastases: Ixabepilone and Vorinostat in Treating Patients With Metastatic Breast Cancer (clinicaltrials.gov) - Apr 6, 2018
P1, N=56, Active, not recruiting,
Active, not recruiting --> Completed Trial completion date: Jun 2018 --> Jun 2019 | Trial primary completion date: Jun 2018 --> Jun 2019
- |||||||||| Ixempra (ixabepilone) - Otsuka, R / Pharm, Torisel (temsirolimus) / Pfizer
Enrollment change, Trial primary completion date, Surgery, Metastases: Ixabepilone and Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery (clinicaltrials.gov) - Feb 8, 2018
P1, N=22, Active, not recruiting,
Not yet recruiting --> Recruiting N=30 --> 22 | Trial primary completion date: Jun 2017 --> Feb 2017
- |||||||||| triciribine phosphate (VQD 002) / VioQuest, Prescient Therap
Clinical, Journal, Combination therapy: The AKT inhibitor triciribine in combination with paclitaxel has order-specific efficacy against Zfp217-induced breast cancer chemoresistance. (Pubmed Central) - Jan 10, 2018
Preclinical animal models of Zfp217 overexpression were treated with a combination therapy of the microtubule inhibitor epothilone B, doxorubicin (Adriamycin), and cyclophosphamide (EAC)...Combination treatment of triciribine followed by paclitaxel (TCN→PAC) inhibited tumor burden and increased survival in tumors that overexpressed Zfp217, whereas single agent or combination treatment in the reverse order (PAC→TCN) did not improve response. Analysis of these tumors and patient-derived tumor xenograft tumors treated with the same therapies suggested that Zfp217 overexpression in tumors contributes both to decreased microvessel density and vessel maturity, while TCN→PAC tumors overexpressing Zfp217 showed improved vessel maturity.
- |||||||||| litronesib (KF 89617) / Kyowa Kirin, Eli Lilly
Enrollment change, Metastases: A Study of LY2523355 in Participants With Breast Cancer (clinicaltrials.gov) - Dec 19, 2017
P2, N=39, Completed,
Analysis of these tumors and patient-derived tumor xenograft tumors treated with the same therapies suggested that Zfp217 overexpression in tumors contributes both to decreased microvessel density and vessel maturity, while TCN→PAC tumors overexpressing Zfp217 showed improved vessel maturity. N=60 --> 39
- |||||||||| triciribine phosphate (VQD 002) / VioQuest, Prescient Therap
Journal: The AKT inhibitor triciribine in combination with paclitaxel has order-specific efficacy against Zfp217-induced breast cancer chemoresistance. (Pubmed Central) - Jul 27, 2017
Preclinical animal models of Zfp217 overexpression were treated with a combination therapy of the microtubule inhibitor epothilone B, doxorubicin (Adriamycin), and cyclophosphamide (EAC)...Combination treatment of triciribine followed by paclitaxel (TCN→PAC) inhibited tumor burden and increased survival in tumors that overexpressed Zfp217, whereas single agent or combination treatment in the reverse order (PAC→TCN) did not improve response. Analysis of these tumors and patient-derived tumor xenograft tumors treated with the same therapies suggested that Zfp217 overexpression in tumors contributes both to decreased microvessel density and vessel maturity, while TCN→PAC tumors overexpressing Zfp217 showed improved vessel maturity.
- |||||||||| Biomarker, Journal: Emerging Treatment using Tubulin Inhibitors in Advanced Non-Small Cell Lung Cancer. (Pubmed Central) - Jul 26, 2017
The article then provides a summary of novel tubulin inhibitors, including cabazitaxel, eribulin, ixabepilone, patupilone, plinabulin, new colchicine analogues and others...Expert Opinion: Tubulin inhibitors will likely continue to play important roles in NSCLC management due to the advent of novel agents and combinations. Through further understanding of tumor biology, investigation of drug resistance, and development of predictive biomarkers, we will be better positioned to incorporate microtubule inhibition into patient specific treatment strategies.
- |||||||||| Ixempra (ixabepilone) - Otsuka, R / Pharm, Allarity Therap
Trial completion, Enrollment change, Metastases: Phase II Study of Ixabepilone in Metastatic Breast Cancer and Its Effects on the Ultrastructure of Neurons (clinicaltrials.gov) - Jul 13, 2017
P2, N=15, Completed,
Through further understanding of tumor biology, investigation of drug resistance, and development of predictive biomarkers, we will be better positioned to incorporate microtubule inhibition into patient specific treatment strategies. Recruiting --> Completed | N=20 --> 15
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