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- ||| Halaven (eribulin mesylate) / Eisai
Enrollment closed: Neoadjuvant Study of Sequential Eribulin Followed by FAC Compared to Sequential Paclitaxel Followed by FEC in Early Stage Breast Cancer Not Overexpressing HER-2 (clinicaltrials.gov) - Sep 15, 2014
P2, N=162, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
Recruiting --> Active, not recruiting
- Halaven (eribulin mesylate) / Eisai
Enrollment open, Trial initiation date: AOST1322: Eribulin Mesylate in Treating Patients With Recurrent or Refractory Osteosarcoma (clinicaltrials.gov) - Sep 8, 2014
P2, N=33, Recruiting, Sponsor: National Cancer Institute (NCI)
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting | Initiation date: May 2014 --> Aug 2014
- Halaven (eribulin mesylate) / Eisai
Trial primary completion date: An Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function (clinicaltrials.gov) - Sep 5, 2014
P1, N=18, Active, not recruiting, Sponsor: Eisai Inc.
Not yet recruiting --> Recruiting | Initiation date: May 2014 --> Aug 2014 Trial primary completion date: Mar 2014 --> Jul 2013
- Halaven (eribulin mesylate) / Eisai, Herceptin (trastuzumab) / Roche
Enrollment change, Trial termination: Study of Neoadjuvant Carboplatin, Eribulin and Trastuzumab for Operable HER2 Positive Breast Cancer (clinicaltrials.gov) - Sep 5, 2014
P1/2, N=12, Terminated, Sponsor: ACORN Research, LLC
Trial primary completion date: Mar 2014 --> Jul 2013 N=56 --> 12 | Active, not recruiting --> Terminated; Closed early due to increased hematologic toxicity and possible reduced efficacy
- Avastin (bevacizumab) / Roche, Halaven (eribulin mesylate) / Eisai
Enrollment open: GIM11-BERGI: Safety and Efficacy Study of Eribulin in Combination With Bevacizumab for Second-line Treatment HER2- MBC Patients (clinicaltrials.gov) - Sep 5, 2014
P2, N=61, Recruiting, Sponsor: Consorzio Oncotech
N=56 --> 12 | Active, not recruiting --> Terminated; Closed early due to increased hematologic toxicity and possible reduced efficacy Not yet recruiting --> Recruiting
- Avastin (bevacizumab) / Roche, Halaven (eribulin mesylate) / Eisai
Enrollment closed, Trial primary completion date: First Line Metastatic Breast Cancer Treatment (ESMERALDA) (clinicaltrials.gov) - Sep 4, 2014
P2, N=59, Active, not recruiting, Sponsor: ARCAGY/ GINECO GROUP
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2014 --> May 2015
- |||||||||| Halaven (eribulin mesylate) / Eisai
New P3 trial: Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes (clinicaltrials.gov) - Aug 26, 2014
P3, N=440, Recruiting, Sponsor: Eisai Co., Ltd.
- |||| Cyramza (ramucirumab) / Eli Lilly
Trial completion, Combination therapy, Monotherapy, Metastases: A Study of Ramucirumab (IMC-1121B) in Combination With Eribulin Versus Eribulin Alone in Participants With Breast Cancer (clinicaltrials.gov) - Aug 19, 2014
P2, N=141, Completed, Sponsor: Eli Lilly and Company
Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2014 --> May 2015 Active, not recruiting --> Completed
- || Halaven (eribulin mesylate) / Eisai
Trial primary completion date, Combination therapy: Eribulin in Combination With Cyclophosphamide in Patients With Solid Tumor Malignancies (clinicaltrials.gov) - Aug 18, 2014
P1/2, N=58, Recruiting, Sponsor: University of California, San Francisco
Active, not recruiting --> Completed Trial primary completion date: Sep 2013 --> Sep 2015
- Halaven (eribulin mesylate) / Eisai
New P2 trial: Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Eribulin Chemotherapy (ACE) in Operable HER2-negative Breast Cancer (clinicaltrials.gov) - Aug 15, 2014
P2, N=30, Not yet recruiting, Sponsor: Sidney Kimmel Comprehensive Cancer Center
- Halaven (eribulin mesylate) / Eisai
Trial initiation date, Trial primary completion date: An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer Refractory (clinicaltrials.gov) - Jul 28, 2014
P=N/A, N=0, Available, Sponsor: Eisai Inc.
Trial primary completion date: Sep 2013 --> Sep 2015 Initiation date: Aug 2010 --> Mar 2011 | Trial primary completion date: Mar 2012 --> Mar 2015
- || Halaven (eribulin mesylate) / Eisai
Trial primary completion date, Combination therapy, Metastases: Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of Sorafenib and Eribulin in Combination (clinicaltrials.gov) - Jul 27, 2014
P1, N=54, Recruiting, Sponsor: Bayer
Initiation date: Aug 2010 --> Mar 2011 | Trial primary completion date: Mar 2012 --> Mar 2015 Trial primary completion date: Jan 2015 --> Apr 2015
- ||| Halaven (eribulin mesylate) / Eisai
Enrollment change, Trial initiation date, Trial primary completion date, Combination therapy, Metastases: Eribulin Mesylate in Combination With Intermittent Erlotinib in Patients With Previously Treated, Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - Jul 23, 2014
P2, N=123, Active, not recruiting, Sponsor: Eisai Inc.
Trial primary completion date: Jan 2015 --> Apr 2015 N=100 --> 123 | Initiation date: Feb 2010 --> Nov 2009 | Trial primary completion date: Dec 2013 --> Sep 2014
- |||| Halaven (eribulin mesylate) / Eisai
Trial completion, Metastases: A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Participants With Advanced Breast Cancer (clinicaltrials.gov) - Jul 23, 2014
P2, N=104, Completed, Sponsor: Eisai Inc.
N=100 --> 123 | Initiation date: Feb 2010 --> Nov 2009 | Trial primary completion date: Dec 2013 --> Sep 2014 Active, not recruiting --> Completed
- || Halaven (eribulin mesylate) / Eisai
Trial primary completion date, Metastases: An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Previously Treated Subjects With Advanced or Metastatic Soft Tissue Sarcoma (Study E7389-J081-217) (clinicaltrials.gov) - Jul 17, 2014
P2, N=51, Active, not recruiting, Sponsor: Eisai Co., Ltd.
Active, not recruiting --> Completed Trial primary completion date: Jan 2014 --> Jan 2016
- Halaven (eribulin mesylate) / Eisai
Enrollment change, Trial primary completion date: A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer (clinicaltrials.gov) - Jul 17, 2014
P1, N=12, Active, not recruiting, Sponsor: Eisai Co., Ltd.
Trial primary completion date: Jan 2014 --> Jan 2016 N=24 --> 12 | Trial primary completion date: Oct 2014 --> May 2014
- Halaven (eribulin mesylate) / Eisai, Herceptin (trastuzumab) / Roche
Enrollment closed: Efficacy and Tolerability of Eribulin Plus Lapatinib in Patients With Metastatic Breast Cancer (E-VITA) (clinicaltrials.gov) - Jul 17, 2014
P2, N=80, Active, not recruiting, Sponsor: German Breast Group
N=24 --> 12 | Trial primary completion date: Oct 2014 --> May 2014 Recruiting --> Active, not recruiting
- Halaven (eribulin mesylate) / Eisai
Trial primary completion date: Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer (clinicaltrials.gov) - Jul 8, 2014
P2, N=50, Active, not recruiting, Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)
Recruiting --> Active, not recruiting Trial primary completion date: Jun 2014 --> Mar 2014
- Halaven (eribulin mesylate) / Eisai
New P2 trial, Surgery, Metastases: Gemcitabine Hydrochloride and Eribulin Mesylate in Treating Patients With Bladder Cancer That is Advanced or Cannot Be Removed by Surgery (clinicaltrials.gov) - Jul 1, 2014
P2, N=21, Not yet recruiting, Sponsor: National Cancer Institute (NCI)
- ||| Halaven (eribulin mesylate) / Eisai
New P1 trial: BOLD 113: This is a Phase 1 Study of Eribulin Mesylate in Pediatric Participants With Recurrent or Refractory Solid Tumors (Excluding [Central Nervous System] CNS), Including Lymphomas (clinicaltrials.gov) - Jun 27, 2014
P1, N=94, Not yet recruiting, Sponsor: Eisai Inc.
- | Avastin (bevacizumab) / Roche, Halaven (eribulin mesylate) / Eisai
New P2 trial: GIM11-BERGI: Safety and Efficacy Study of Eribulin in Combination With Bevacizumab for Second-line Treatment HER2- MBC Patients (clinicaltrials.gov) - Jun 26, 2014
P2, N=61, Not yet recruiting, Sponsor: Consorzio Oncotech
- || Halaven (eribulin mesylate) / Eisai
Trial primary completion date, Combination therapy, Metastases: Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of Sorafenib and Eribulin in Combination (clinicaltrials.gov) - Jun 26, 2014
P1, N=54, Recruiting, Sponsor: Bayer
Trial primary completion date: Jun 2014 --> Mar 2014 Trial primary completion date: Aug 2014 --> Oct 2014
- ||| Halaven (eribulin mesylate) / Eisai
Enrollment closed, Combination therapy, Metastases: Eribulin Mesylate Administered in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladder Cancer (clinicaltrials.gov) - Jun 24, 2014
P1/2, N=95, Active, not recruiting, Sponsor: Eisai Inc.
Trial primary completion date: Aug 2014 --> Oct 2014 Recruiting --> Active, not recruiting
- Halaven (eribulin mesylate) / Eisai
Trial primary completion date, Metastases: Trial of Eribulin Followed by Doxorubicin & Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer (clinicaltrials.gov) - May 20, 2014
P2, N=47, Recruiting, Sponsor: Emory University
Recruiting --> Active, not recruiting Trial primary completion date: Oct 2014 --> Oct 2015
- Halaven (eribulin mesylate) / Eisai
Trial completion date, Metastases: Trial of Eribulin Followed by Doxorubicin & Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer (clinicaltrials.gov) - May 20, 2014
P2, N=47, Recruiting, Sponsor: Emory University
Trial primary completion date: Oct 2014 --> Oct 2015 Trial completion date: Oct 2014 --> Oct 2015
- Halaven (eribulin mesylate) / Eisai
Trial primary completion date: Eribulin Mesylate and Cisplatin in Treating Patients With Advanced Solid Tumors (clinicaltrials.gov) - May 18, 2014
P1, N=36, Completed, Sponsor: National Cancer Institute (NCI)
Trial completion date: Oct 2014 --> Oct 2015 Trial primary completion date: Jun 2014 --> May 2014
- Halaven (eribulin mesylate) / Eisai
Trial primary completion date, Metastases: Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction (clinicaltrials.gov) - May 18, 2014
P1/2, N=148, Recruiting, Sponsor: National Cancer Institute (NCI)
Trial primary completion date: Jun 2014 --> May 2014 Trial primary completion date: Jun 2014 --> Dec 2015
- Halaven (eribulin mesylate) / Eisai
Enrollment change: Eribulin Mesylate and Cisplatin in Treating Patients With Advanced Solid Tumors (clinicaltrials.gov) - May 18, 2014
P1, N=36, Completed, Sponsor: National Cancer Institute (NCI)
Trial primary completion date: Jun 2014 --> Dec 2015 N=30 --> 36
- Halaven (eribulin mesylate) / Eisai
Trial completion: Eribulin Mesylate and Cisplatin in Treating Patients With Advanced Solid Tumors (clinicaltrials.gov) - May 18, 2014
P1, N=36, Completed, Sponsor: National Cancer Institute (NCI)
N=30 --> 36 Active, not recruiting --> Completed
- | Halaven (eribulin mesylate) / Eisai
Trial completion date, Combination therapy, Metastases: Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of Sorafenib and Eribulin in Combination (clinicaltrials.gov) - May 1, 2014
P1, N=54, Recruiting, Sponsor: Bayer
Active, not recruiting --> Completed Trial completion date: Aug 2014 --> Oct 2014
- ||| Halaven (eribulin mesylate) / Eisai
Enrollment closed: Trial of Eribulin/Cyclophosphamide or Docetaxel/Cyclophosphamide as Neoadjuvant Therapy in Locally Advanced HER2-Negative Breast Cancer (clinicaltrials.gov) - Apr 30, 2014
P2, N=76, Active, not recruiting, Sponsor: SCRI Development Innovations, LLC
Trial completion date: Aug 2014 --> Oct 2014 Recruiting --> Active, not recruiting
- Halaven (eribulin mesylate) / Eisai
Trial completion: Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer (clinicaltrials.gov) - Apr 28, 2014
P2, N=74, Completed, Sponsor: National Cancer Institute (NCI)
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- |||| Halaven (eribulin mesylate) / Eisai
Trial completion, Metastases: E7389 Administered as an IV Bolus Infusion Day 1 and Day 8 Every 3 Weeks in Pre-Treated Patients With Advanced and/or Metastatic Soft Tissue Sarcoma (clinicaltrials.gov) - Apr 21, 2014
P2, N=128, Completed, Sponsor: Eisai Inc.
Active, not recruiting --> Completed Terminated --> Completed
- Halaven (eribulin mesylate) / Eisai
New P1 trial, Metastases: Eribulin Mesylate and Everolimus in Treating Patients With Triple-Negative Metastatic Breast Cancer (clinicaltrials.gov) - Apr 20, 2014
P1, N=45, Not yet recruiting, Sponsor: City of Hope Medical Center
- |||| Halaven (eribulin mesylate) / Eisai
Trial primary completion date, Metastases: E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes (clinicaltrials.gov) - Apr 17, 2014
P3, N=1102, Active, not recruiting, Sponsor: Eisai Inc.
Terminated --> Completed Trial primary completion date: Jan 2012 --> Dec 2014
- ||| Halaven (eribulin mesylate) / Eisai
Trial completion date, Metastases: E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes (clinicaltrials.gov) - Apr 17, 2014
P3, N=1102, Active, not recruiting, Sponsor: Eisai Inc.
Trial primary completion date: Jan 2012 --> Dec 2014 Trial completion date: Mar 2012 --> Feb 2015
- ||||| Halaven (eribulin mesylate) / Eisai
Enrollment closed, Metastases: E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes (clinicaltrials.gov) - Apr 17, 2014
P3, N=1102, Active, not recruiting, Sponsor: Eisai Inc.
Trial completion date: Mar 2012 --> Feb 2015 Completed --> Active, not recruiting
- ||| Halaven (eribulin mesylate) / Eisai
Enrollment change, Metastases: ESKIMO: Eribulin Mesylate Phase IV Clinical Trial in Korean Patients With Metastatic or Locally Advanced Breast Cancer (clinicaltrials.gov) - Apr 16, 2014
P4, N=100, Active, not recruiting, Sponsor: Eisai Korea Inc.
Completed --> Active, not recruiting N=56 --> 100
- |||||| Lynparza (olaparib) / Merck (MSD), AstraZeneca
Enrollment open, Monotherapy, BRCA Biomarker, PARP Biomarker, Metastases: OlympiAD: Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations. (clinicaltrials.gov) - Apr 16, 2014
P3, N=2820, Recruiting, Sponsor: AstraZeneca
N=56 --> 100 Not yet recruiting --> Recruiting
- ||| Halaven (eribulin mesylate) / Eisai
Enrollment closed, Metastases: ESKIMO: Eribulin Mesylate Phase IV Clinical Trial in Korean Patients With Metastatic or Locally Advanced Breast Cancer (clinicaltrials.gov) - Apr 16, 2014
P4, N=100, Active, not recruiting, Sponsor: Eisai Korea Inc.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- Halaven (eribulin mesylate) / Eisai
Enrollment open: Study of Eribulin in Children With Cancer to Determine Safety (clinicaltrials.gov) - Apr 9, 2014
P1, N=15, Recruiting, Sponsor: University of Oklahoma
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- Halaven (eribulin mesylate) / Eisai
New P2 trial: AOST1322: Eribulin Mesylate in Treating Patients With Recurrent or Refractory Osteosarcoma (clinicaltrials.gov) - Mar 25, 2014
P2, N=33, Not yet recruiting, Sponsor: National Cancer Institute (NCI)
- ||||| Lynparza (olaparib) / Merck (MSD), AstraZeneca
Enrollment change, Monotherapy, BRCA Biomarker, PARP Biomarker, Metastases: OlympiAD: Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations. (clinicaltrials.gov) - Mar 18, 2014
P3, N=2820, Recruiting, Sponsor: AstraZeneca
Not yet recruiting --> Recruiting N=310 --> 2820
- Korlym (mifepristone) / Corcept Therap
Enrollment open, Combination therapy, Metastases: Mifepristone and Eribulin in Patients With Metastatic Triple Negative Breast Cancer or Other Specified Solid Tumors (clinicaltrials.gov) - Mar 17, 2014
P1, N=40, Recruiting, Sponsor: Corcept Therapeutics
N=310 --> 2820 Not yet recruiting --> Recruiting
- Halaven (eribulin mesylate) / Eisai
New P1 trial: Study of Eribulin in Children With Cancer to Determine Safety (clinicaltrials.gov) - Mar 6, 2014
P1, N=15, Recruiting, Sponsor: University of Oklahoma
- |||| Halaven (eribulin mesylate) / Eisai
Trial completion, Metastases: Phase II Study Of E7389, Halichondrin B Analogue, In Patients With Advanced Non-Small Cell Lung Cancer, NSCLC, Who Progressed During Or After Platinum-Based Doublet Chemotherapy (clinicaltrials.gov) - Feb 22, 2014
P2, N=106, Completed, Sponsor: Eisai Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- |||| Halaven (eribulin mesylate) / Eisai
Trial completion, Metastases: A Study of E7389 in Advanced/Metastatic Breast Cancer Patients (clinicaltrials.gov) - Feb 22, 2014
P2, N=104, Completed, Sponsor: Eisai Inc.
Active, not recruiting --> Completed No longer recruiting --> Completed
- | Halaven (eribulin mesylate) / Eisai
Trial completion, Metastases: Study of E7389 Administered Once Every 3 Weeks In Patients With Advanced Solid Tumors (clinicaltrials.gov) - Feb 22, 2014
P1, N=21, Completed, Sponsor: Eisai Inc.
No longer recruiting --> Completed No longer recruiting --> Completed
- | Halaven (eribulin mesylate) / Eisai
Trial completion: Study of E7389 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Feb 22, 2014
P1, N=33, Completed, Sponsor: Eisai Inc.
No longer recruiting --> Completed Recruiting --> Completed
- | Halaven (eribulin mesylate) / Eisai
Trial completion: E7389 in Treating Patients With Advanced Solid Tumors (clinicaltrials.gov) - Feb 22, 2014
P1, N=31, Completed, Sponsor: National Cancer Institute (NCI)
Recruiting --> Completed Active, not recruiting --> Completed