Clinical Trials

Numerous clinical trials evaluate the safety and efficacy of ixabepilone across Phase 1 through Phase 3 studies in solid tumors, including metastatic and recurrent breast, epithelial ovarian, prostate, endometrial, and head and neck cancers. Sponsored by academic medical centers, government organizations such as the National Cancer Institute, and pharmaceutical companies including Bristol-Myers Squibb and R-Pharm, these studies assess single-agent and combination regimens. Protocol recruitment statuses range from completed evaluations to active, withdrawn, and terminated trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00877500 ACTIVE_NOT_RECRUITING
Bilateral Breast Carcinoma; HER2/Neu Negative; Invasive Breast Carcinoma
M.D. Anderson Cancer Center
 2009-03-30 PHASE2
NCT04796324 TERMINATED
Metastatic Breast Cancer
Allarity Therapeutics
 2021-03-01 PHASE2
NCT03093155 COMPLETED
Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer
Yale University
 2017-04-03 PHASE2
NCT02915744 COMPLETED
Metastasis; Breast Cancer
Nektar Therapeutics
 2016-11 PHASE3
NCT01097642 COMPLETED
Breast Cancer
The Methodist Hospital Research Institute
 2008-10-10 PHASE2
NCT01446016 COMPLETED
Breast Neoplasms; Breast Cancer
The Methodist Hospital Research Institute
 2011-09 PHASE2
NCT01375829 ACTIVE_NOT_RECRUITING
Adult Solid Neoplasm
National Cancer Institute (NCI)
 2011-06-27 PHASE1
NCT00630032 COMPLETED
Breast Cancer
UNICANCER
 2007-09 PHASE3
NCT03093155 Completed
Epithelial Ovarian Cancer|Fallopian Tube Cancer|Primary Peritoneal Cancer
Yale University|R-Pharm-US LLC
 2017-04-03 Phase 2
NCT00923130 COMPLETED
Renal Cell Carcinoma
National Cancer Institute (NCI)
 2009-01-07 PHASE2
NCT00789581 COMPLETED
Breast Cancer
SCRI Development Innovations, LLC
 2008-12 PHASE3
NCT01349088 WITHDRAWN
Breast Cancer; Metastatic Breast Cancer; Stage IV Breast Cancer
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
 2013-12 PHASE1; PHASE2
NCT00798252 COMPLETED
Advanced Cancer
Bristol-Myers Squibb
 2009-03 PHASE1
NCT01818999 WITHDRAWN
METASTATIC BREAST CANCER
University of Texas Southwestern Medical Center
 2013-08 PHASE2
NCT00977574 ACTIVE_NOT_RECRUITING
Endometrial Adenocarcinoma; Endometrial Adenosquamous Carcinoma; Endometrial Clear Cell Adenocarcinoma; Endometrial Serous Adenocarcinoma; Recurrent Malignant Uterine Corpus Neoplasm; Stage IIIA Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage; Stage IIIB Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage; Stage IIIC Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage; Stage IVA Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage; Stage IVB Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage
National Cancer Institute (NCI)
 2009-09-14 PHASE2
NCT01220609 COMPLETED
Recurrent Uterine Corpus Sarcoma; Uterine Corpus Leiomyosarcoma
National Cancer Institute (NCI)
 2010-11 PHASE2
NCT00866905 COMPLETED
Breast Cancer
SCRI Development Innovations, LLC
 2009-04 PHASE2
NCT00785291 COMPLETED
Estrogen Receptor Negative; Estrogen Receptor Positive; HER2/Neu Negative; HER2/Neu Positive; Progesterone Receptor Negative; Progesterone Receptor Positive; Recurrent Breast Carcinoma; Stage IIIC Breast Cancer AJCC v6; Stage IV Breast Cancer AJCC v6 and v7
National Cancer Institute (NCI)
 2008-10-13 PHASE3
NCT00924066 TERMINATED
Cervical Carcinoma; Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Cervical Carcinoma, Non-SquamousType
National Cancer Institute (NCI)
 2008-11 PHASE2
NCT01057212 TERMINATED
Non-squamous Non-small Cell Lung Cancer
Providence Health & Services
 2010-02 PHASE2
NCT01168232 COMPLETED
Recurrent Uterine Corpus Sarcoma; Uterine Carcinosarcoma
National Cancer Institute (NCI)
 2010-09-07 PHASE2
NCT00884676 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Jaime Merchan
 2008-11 PHASE1
NCT00924352 COMPLETED
Metastatic Breast Cancer
Accelerated Community Oncology Research Network
 2009-06 PHASE1; PHASE2
NCT00825734 COMPLETED
Metastatic Breast Cancer
SCRI Development Innovations, LLC
 2009-03 PHASE1; PHASE2
NCT01075100 COMPLETED
Metastatic Breast Cancer
US Oncology Research
 2010-01 PHASE2
NCT00879086 COMPLETED
Breast Cancer
Eisai Inc.
 2009-03-31 PHASE2
NCT01454479 UNKNOWN
Recurrent Endometrial Cancer
Hung-Hsueh Chou
 2011-03 PHASE1
NCT01012362 TERMINATED
Breast Cancer; Lung Cancer; Colon Cancer; Pancreatic Cancer; Head and Neck Cancer; Kidney Cancer; Sarcoma; Hepatocellular Cancer
Masonic Cancer Center, University of Minnesota
 2009-12 PHASE1
NCT01084057 COMPLETED
Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer
City of Hope Medical Center
 2010-05-17 PHASE1
NCT01416389 COMPLETED
Metastatic Breast Cancer
Eli Lilly and Company
 2011-08 PHASE2
NCT00883116 TERMINATED
Endometrial Cancer
R-Pharm
 2009-08 PHASE3
NCT00182767 COMPLETED
Fallopian Tube Cancer; Female Reproductive Cancer; Recurrent Breast Cancer; Recurrent Ovarian Epithelial Cancer; Stage III Ovarian Epithelial Cancer; Stage IV Breast Cancer; Stage IV Ovarian Epithelial Cancer
National Cancer Institute (NCI)
 2006-01 PHASE1; PHASE2
NCT00765765 TERMINATED
Breast Cancer
University of Medicine and Dentistry of New Jersey
 2009-02 PHASE1; PHASE2
NCT00637897 COMPLETED
Breast Cancer
Wake Forest University Health Sciences
 2008-03 PHASE1
NCT01079793 WITHDRAWN
Prostate Cancer
University of Texas Southwestern Medical Center
 2010-05-26 PHASE1; PHASE2
NCT00804310 TERMINATED
Unspecified Adult Solid Tumor, Protocol Specific
University of California, Davis
 2009-08 PHASE1
NCT00821886 COMPLETED
Breast Cancer
SCRI Development Innovations, LLC
 2009-02 PHASE2
NCT00751868 COMPLETED
Breast Cancer
Consorzio Oncotech
 2008-09 PHASE2
NCT00983801 COMPLETED
Stomach Neoplasms
R-Pharm
 2009-11 PHASE2
NCT00490646 COMPLETED
Metastatic Breast Cancer
R-Pharm
 2008-02 PHASE2
NCT00717704 COMPLETED
Solid Tumor
Medstar Health Research Institute
 2008-07 PHASE1
NCT00790894 TERMINATED
Metastatic Breast Cancer
Hellenic Cooperative Oncology Group
 2008-11 PHASE2
NCT00672009 TERMINATED
Prostatic Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Adenocarcinoma; Prostatic Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
Cedars-Sinai Medical Center
 2008-04 PHASE2
NCT01454479 Unknown status
Recurrent Endometrial Cancer
Hung-Hsueh Chou|GlaxoSmithKline|Bristol-Myers Squibb|Chang Gung Memorial Hospital
 2011-03 Phase 1
NCT00828308 COMPLETED
Prostate Cancer
Brown University
 2009-02 PHASE2
NCT00627978 COMPLETED
Metastatic Breast Cancer
Weill Medical College of Cornell University
 2007-11 PHASE2
NCT00832117 COMPLETED
Non Small Cell Lung Cancer
R-Pharm
 2009-05 PHASE1
NCT00331344 COMPLETED
Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IV Prostate Cancer
National Cancer Institute (NCI)
 2006-04 PHASE1; PHASE2
NCT00741988 COMPLETED
Non-Small Cell Lung Cancer
SCRI Development Innovations, LLC
 2008-09 PHASE2
NCT00633464 COMPLETED
Triple Negative Locally Advanced Non-resectable Breast Cancer; Metastatic Breast Cancer
R-Pharm
 2008-06 PHASE2
NCT00058019 COMPLETED
Anaplastic Large Cell Lymphoma; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma
National Cancer Institute (NCI)
 2003-02 PHASE2
NCT00593827 COMPLETED
Metastatic Breast Cancer
R-Pharm
 2008-05 PHASE2
NCT00998738 TERMINATED
Neuropathy; Pain; Recurrent Breast Carcinoma; Stage IV Breast Cancer
Mayo Clinic
 2009-11 PHASE3
NCT00634088 TERMINATED
Locally Advanced or Metastatic Breast Cancer
R-Pharm
 2008-06 PHASE1
NCT00723957 COMPLETED
Advanced/Metastatic Non-Small Cell Lung Cancer
R-Pharm
 2008-12 PHASE2
NCT00045708 COMPLETED
Adult Anaplastic Astrocytoma; Adult Giant Cell Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor
National Cancer Institute (NCI)
 2002-10 PHASE1; PHASE2
NCT00546364 TERMINATED
Breast Neoplasms
R-Pharm
 2008-02 PHASE2
NCT00025155 COMPLETED
Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer
National Cancer Institute (NCI)
 2002-07 PHASE2
NCT00030108 COMPLETED
Brain and Central Nervous System Tumors; Childhood Germ Cell Tumor; Extragonadal Germ Cell Tumor; Kidney Cancer; Leukemia; Liver Cancer; Neuroblastoma; Ovarian Cancer; Sarcoma; Unspecified Childhood Solid Tumor, Protocol Specific
National Institutes of Health Clinical Center (CC)
 2001-11 PHASE1
NCT00568022 COMPLETED
Breast Cancer
R-Pharm
 2008-02 PHASE1
NCT01012362 Terminated
Breast Cancer|Lung Cancer|Colon Cancer|Pancreatic Cancer|Head and Neck Cancer|Kidney Cancer|Sarcoma|Hepatocellular Cancer
Masonic Cancer Center University of Minnesota|GlaxoSmithKline
 2009-12 Phase 1
NCT00455533 COMPLETED
Breast Cancer
Bristol-Myers Squibb
 2007-10 PHASE2
NCT00998101 WITHDRAWN
Lung Cancer
UNC Lineberger Comprehensive Cancer Center
 2009-07 PHASE2
NCT00370552 COMPLETED
Metastatic Breast Cancer
R-Pharm
 2007-03 PHASE2
NCT00683904 COMPLETED
Non-small Cell Lung Cancer (NSCLC)
R-Pharm
 2008-06 PHASE1
NCT00422097 COMPLETED
Cancer
R-Pharm
 2007-01 PHASE1
NCT00095979 COMPLETED
Endometrial Adenocarcinoma; Recurrent Endometrial Carcinoma; Stage IV Endometrial Carcinoma
National Cancer Institute (NCI)
 2005-05 PHASE2
NCT00383149 COMPLETED
Metastatic Pancreatic Cancer
R-Pharm
 2007-01 PHASE2
NCT00632424 TERMINATED
Advanced Solid Tumors
R-Pharm
 2008-05 PHASE1
NCT00087139 COMPLETED
Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IV Prostate Cancer
National Cancer Institute (NCI)
 2004-09 PHASE2
NCT00077376 COMPLETED
HER2-positive Breast Cancer; Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer
National Cancer Institute (NCI)
 2005-03 PHASE2
NCT00322374 COMPLETED
Metastatic Breast Cancer
R-Pharm
 2006-08 PHASE1
NCT00207090 COMPLETED
Advanced Solid Tumors; Neoplasms
R-Pharm
 2005-09 PHASE1
NCT00079326 TERMINATED
HER2-positive Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer
National Cancer Institute (NCI)
 2004-01 PHASE2
NCT00162136 COMPLETED
Solid Malignancies
R-Pharm
 2005-09 PHASE1
NCT00082433 COMPLETED
Cancer; Breast Cancer
R-Pharm
 2003-11 PHASE3
NCT00058084 COMPLETED
Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IV Prostate Cancer
National Cancer Institute (NCI)
 2003-03 PHASE2
NCT00331643 COMPLETED
Adult Rhabdomyosarcoma; Adult Synovial Sarcoma; Alveolar Childhood Rhabdomyosarcoma; Childhood Synovial Sarcoma; Embryonal Childhood Rhabdomyosarcoma; Previously Treated Childhood Rhabdomyosarcoma; Recurrent Adult Soft Tissue Sarcoma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Childhood Soft Tissue Sarcoma; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Neuroblastoma; Recurrent Osteosarcoma; Recurrent Wilms Tumor and Other Childhood Kidney Tumors
National Cancer Institute (NCI)
 2006-04 PHASE2
NCT00182702 COMPLETED
Clear Cell Renal Cell Carcinoma; Recurrent Renal Cell Cancer; Stage III Renal Cell Cancer; Stage IV Renal Cell Cancer
National Cancer Institute (NCI)
 2005-07 PHASE2
NCT00362830 COMPLETED
Cancer
Bristol-Myers Squibb
 2006-08 PHASE1
NCT00021099 COMPLETED
Distal Urethral Cancer; Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter; Proximal Urethral Cancer; Recurrent Bladder Cancer; Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter; Recurrent Urethral Cancer; Regional Transitional Cell Cancer of the Renal Pelvis and Ureter; Stage III Bladder Cancer; Stage IV Bladder Cancer; Transitional Cell Carcinoma of the Bladder; Urethral Cancer Associated With Invasive Bladder Cancer
National Cancer Institute (NCI)
 2001-06 PHASE2
NCT01019577 COMPLETED
Metastatic Breast Cancer
R-Pharm
 2005-10 PHASE2
NCT00309049 COMPLETED
Cancer
R-Pharm
 2006-04 PHASE1; PHASE2
NCT00030706 COMPLETED
Ovarian Cancer; Peritoneal Cavity Cancer
Montefiore Medical Center
 2004-11 PHASE2
NCT00028561 TERMINATED
Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
 2001-10 PHASE1
NCT01027208 COMPLETED
Metastatic Breast Cancer
R-Pharm
 2006-12 PHASE2
NCT00033618 COMPLETED
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma; Recurrent Metastatic Squamous Neck Cancer With Occult Primary; Recurrent Salivary Gland Cancer; Recurrent Squamous Cell Carcinoma of the Hypopharynx; Recurrent Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Squamous Cell Carcinoma of the Oropharynx; Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Recurrent Verrucous Carcinoma of the Larynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Salivary Gland Squamous Cell Carcinoma; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IVA Salivary Gland Cancer; Stage IVA Squamous Cell Carcinoma of the Larynx; Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVA Squamous Cell Carcinoma of the Oropharynx; Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVA Verrucous Carcinoma of the Larynx; Stage IVA Verrucous Carcinoma of the Oral Cavity; Stage IVB Salivary Gland Cancer; Stage IVB Squamous Cell Carcinoma of the Larynx; Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVB Squamous Cell Carcinoma of the Oropharynx; Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVB Verrucous Carcinoma of the Larynx; Stage IVB Verrucous Carcinoma of the Oral Cavity; Stage IVC Salivary Gland Cancer; Stage IVC Squamous Cell Carcinoma of the Larynx; Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVC Squamous Cell Carcinoma of the Oropharynx; Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVC Verrucous Carcinoma of the Larynx; Stage IVC Verrucous Carcinoma of the Oral Cavity; Tongue Cancer
National Cancer Institute (NCI)
 2002-11 PHASE2
NCT00080262 COMPLETED
Breast Cancer; Metastases
R-Pharm
 2004-02 PHASE2
NCT00080301 COMPLETED
Breast Cancer; Metastases
R-Pharm
 2003-09 PHASE3
NCT00022542 TERMINATED
Recurrent Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma
National Cancer Institute (NCI)
 2001-06 PHASE2
NCT00096317 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Montefiore Medical Center
 2003-03 PHASE1
NCT00207129 COMPLETED
Advanced Solid Tumors; Neoplasms
R-Pharm
 2004-10 PHASE1
NCT00023946 TERMINATED
Adult Primary Cholangiocellular Carcinoma; Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Cholangiocarcinoma of the Extrahepatic Bile Duct; Cholangiocarcinoma of the Gallbladder; Localized Extrahepatic Bile Duct Cancer; Localized Gallbladder Cancer; Localized Resectable Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer; Recurrent Extrahepatic Bile Duct Cancer; Recurrent Gallbladder Cancer; Unresectable Extrahepatic Bile Duct Cancer; Unresectable Gallbladder Cancer
National Cancer Institute (NCI)
 2001-08 PHASE2
NCT00033306 TERMINATED
Colorectal Cancer
University of Alabama at Birmingham
 2002-02 PHASE2
NCT00006221 COMPLETED
Lymphoma; Small Intestine Cancer; Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
 2000-11 PHASE1
NCT01018966 COMPLETED
Solid Tumors
R-Pharm
 2004-04 PHASE1
NCT00036764 COMPLETED
Recurrent Melanoma; Stage IV Melanoma
National Cancer Institute (NCI)
 2002-02 PHASE2
NCT00057850 COMPLETED
Head and Neck Cancer
National Cancer Institute (NCI)
 2002-01 PHASE1; PHASE2
NCT00017043 COMPLETED
Esophageal Cancer; Gastric Cancer
Bristol-Myers Squibb
 2001-02 PHASE2
NCT00020904 COMPLETED
Breast Cancer
Memorial Sloan Kettering Cancer Center
 2001-02 PHASE2
NCT00004927 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
R-Pharm
 1999-07 PHASE1
NCT00017056 COMPLETED
Esophageal Cancer; Gastric Cancer
Memorial Sloan Kettering Cancer Center
 2001-02 PHASE2
NCT00016393 COMPLETED
Prostate Cancer
SWOG Cancer Research Network
 2001-06 PHASE2
NCT00070096 COMPLETED
Brain and Central Nervous System Tumors; Extragonadal Germ Cell Tumor; Ovarian Cancer; Testicular Germ Cell Tumor
Memorial Sloan Kettering Cancer Center
 2003-08 PHASE2
NCT00043095 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Memorial Sloan Kettering Cancer Center
 2002-06 PHASE1
NCT00025194 COMPLETED
Prostate Cancer
Memorial Sloan Kettering Cancer Center
 2001-07 PHASE1; PHASE2
NCT00049244 UNKNOWN
Breast Cancer
R-Pharm
 2002-09 PHASE1
NCT00016965 COMPLETED
Pancreatic Cancer
SWOG Cancer Research Network
 2001-07 PHASE2
NCT01170871 WITHDRAWN
Advanced Solid Tumors
University of Southern California
 PHASE1
NCT00045097 COMPLETED
Breast Cancer
National Cancer Institute (NCI)
 2002-05 PHASE2
NCT00052572 COMPLETED
Leukemia; Lymphoma
Memorial Sloan Kettering Cancer Center
 2002-10 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-05-22)

Check the Ixabepilone product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ixabepilone selectively binds to beta-tubulin subunits to promote microtubule assembly and suppress dynamic instability, thereby causing cell cycle arrest at the G2/M phase transition. This induction of mitotic failure triggers apoptotic cell death, providing the mechanistic basis for suppressing tumor growth in clinical indications such as advanced breast cancer, ovarian carcinoma, and other solid tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.