Clinical Trials

Numerous clinical trials evaluate vinorelbine ditartrate across Phase 1 through Phase 3 studies for oncological indications including advanced breast cancer, non-small cell lung cancer, rhabdomyosarcoma, and malignant mesothelioma. Sponsored by academic medical centers and biopharmaceutical entities such as Seagen Inc., Taiwan Liposome Company, and City of Hope Medical Center, these investigations examine novel combination regimens and liposomal formulations. Current trial statuses range from actively recruiting and completed to terminated or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04896320 Withdrawn
Breast Cancer Stage IV
Providence Health & Services|Seagen Inc.
 2021-12-15 Phase 1|Phase 2
NCT04299113 Recruiting
Rhabdomyosarcoma
Jonsson Comprehensive Cancer Center|Mirati Therapeutics Inc.|Phase One Foundation
 2020-05-14 Phase 1
NCT03891173 Terminated
Lung Adenocarcinoma
Helix BioPharma Corporation|KCR S.A.
 2019-02-19 Phase 2
NCT02925000 Completed
Cancer
Taiwan Liposome Company
 2017-06-19 Phase 1|Phase 2
NCT02658084 Terminated
Breast Cancer|Metastatic Breast Cancer
University of Miami|Genentech Inc.
 2017-04-12 Phase 1|Phase 2
NCT02768415 Unknown status
Breast Cancer
Chinese Academy of Medical Sciences|ChineseAMS
 2016-06 Phase 2
NCT00828074 COMPLETED
Breast Cancer
City of Hope Medical Center
 2008-11 PHASE1; PHASE2
NCT00266110 COMPLETED
Breast Cancer
UNC Lineberger Comprehensive Cancer Center
 2005-12 PHASE2
NCT01155258 COMPLETED
Extensive Stage Small Cell Lung Cancer; Hereditary Paraganglioma; Male Breast Cancer; Malignant Paraganglioma; Metastatic Gastrointestinal Carcinoid Tumor; Metastatic Pheochromocytoma; Pancreatic Polypeptide Tumor; Recurrent Breast Cancer; Recurrent Cervical Cancer; Recurrent Endometrial Carcinoma; Recurrent Gastrointestinal Carcinoid Tumor; Recurrent Islet Cell Carcinoma; Recurrent Neuroendocrine Carcinoma of the Skin; Recurrent Non-small Cell Lung Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Ovarian Germ Cell Tumor; Recurrent Pheochromocytoma; Recurrent Prostate Cancer; Recurrent Renal Cell Cancer; Recurrent Small Cell Lung Cancer; Recurrent Uterine Sarcoma; Regional Gastrointestinal Carcinoid Tumor; Regional Pheochromocytoma; Stage III Cervical Cancer; Stage III Endometrial Carcinoma; Stage III Neuroendocrine Carcinoma of the Skin; Stage III Ovarian Epithelial Cancer; Stage III Ovarian Germ Cell Tumor; Stage III Prostate Cancer; Stage III Renal Cell Cancer; Stage III Uterine Sarcoma; Stage IIIA Breast Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Breast Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer; Stage IV Endometrial Carcinoma; Stage IV Neuroendocrine Carcinoma of the Skin; Stage IV Non-small Cell Lung Cancer; Stage IV Ovarian Epithelial Cancer; Stage IV Ovarian Germ Cell Tumor; Stage IV Prostate Cancer; Stage IV Renal Cell Cancer; Stage IV Uterine Sarcoma; Stage IVA Cervical Cancer; Stage IVB Cervical Cancer; Thyroid Gland Medullary Carcinoma
University of Southern California
 2010-06 PHASE1
NCT00881387 WITHDRAWN
Lymphoma
University of Miami
 2009-02 PHASE2
NCT00540982 COMPLETED
Lung Cancer; Unspecified Adult Solid Tumor, Protocol Specific
City of Hope Medical Center
 1997-02-20 PHASE1; PHASE2
NCT00088985 TERMINATED
Breast Cancer
UNC Lineberger Comprehensive Cancer Center
 2004-01 PHASE2
NCT00354393 COMPLETED
Malignant Mesothelioma
The Cleveland Clinic
 2002-08 PHASE2
NCT00389922 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
University of California, Davis
 2005-12 PHASE1
NCT00075673 TERMINATED
Breast Cancer
Case Comprehensive Cancer Center
 2003-11 PHASE1
NCT00005847 COMPLETED
Prostate Cancer
Eastern Cooperative Oncology Group
 2001-04-05 PHASE2
NCT00002583 COMPLETED
Lung Cancer
NCIC Clinical Trials Group
 1994-07-07 PHASE3
NCT00003963 COMPLETED
Lymphoma
Jonsson Comprehensive Cancer Center
 1999-05 PHASE2
NCT00057798 COMPLETED
Lung Cancer
Roswell Park Cancer Institute
 2000-03 PHASE2
NCT00006372 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Case Comprehensive Cancer Center
 2000-02 PHASE1
NCT00004105 COMPLETED
Leukemia; Lymphoma; Sarcoma; Unspecified Adult Solid Tumor, Protocol Specific
NYU Langone Health
 1998-09 PHASE1; PHASE2
NCT00014430 COMPLETED
Breast Cancer
Dartmouth-Hitchcock Medical Center
 1999-11 PHASE1
NCT00004096 COMPLETED
Lung Cancer
Northwestern University
 1999-08 PHASE1; PHASE2
NCT00006682 COMPLETED
Breast Cancer
Medstar Health Research Institute
 2000-02 PHASE2
NCT00055887 WITHDRAWN
Lung Cancer
Spectrum Pharmaceuticals, Inc
 2002-11 PHASE3

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Vinorelbine Ditartrate (KW-2307) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vinorelbine ditartrate selectively binds to tubulin, disrupting dynamic microtubule assembly and preventing proper mitotic spindle formation during cell division. This inhibition arrests the cell cycle at the G2/M phase and induces apoptosis, thereby suppressing tumor proliferation in clinical trial conditions such as metastatic breast cancer and non-small cell lung cancer.

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.