Last reviewed · How we verify
NCT02639858
A Phase II Study to Evaluate the Efficacy and Safety of Docetaxel-PM in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Phase 2 trial testing Docetaxel-PM in Head and Neck Squamous Cell Carcinoma in 31 participants. Status unknown.
1 September 2020
Quick facts
| Lead sponsor | Samyang Biopharmaceuticals Corporation |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 31 |
| Start date | 1 October 2015 |
| Primary completion | 1 September 2020 |
| Estimated completion | 1 September 2020 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Docetaxel-PM — full drug profile →
Conditions studied
- Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →
Sponsor
Samyang Biopharmaceuticals Corporation — full company profile →
Who can join
Adults 20 to 79, any sex, with Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Response rate as assessed by RECIST v1.1
Time frame: 2 years
Response is confirmed at least 4 weeks later. Assessment: every 6 weeks (treatment period), every 2 months (follow-up period)
Sponsor's own description
A phase II study to evaluate the efficacy and safety of Docetaxel-PM in recurrent or metastatic head and neck squamous cell carcinoma
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Nanoparticles in the clinic: An update.
Anselmo AC, Mitragotri S. · · 2019 · cited 976× · PMID 31572799 · DOI 10.1002/btm2.10143 -
Nanoparticles in the clinic.
Anselmo AC, Mitragotri S. · · 2016 · cited 773× · PMID 29313004 · DOI 10.1002/btm2.10003 -
Polymeric micelles for the delivery of poorly soluble drugs: From nanoformulation to clinical approval.
Hwang D, Ramsey JD, Kabanov AV. · · 2020 · cited 376× · PMID 32980449 · DOI 10.1016/j.addr.2020.09.009 -
Nanoparticles in the clinic: An update post COVID-19 vaccines.
Anselmo AC, Mitragotri S. · · 2021 · cited 211× · PMID 34514159 · DOI 10.1002/btm2.10246 -
Stimuli-responsive polymeric micelles for drug delivery and cancer therapy.
Zhou Q, Zhang L, Yang T, Wu H. · · 2018 · cited 195× · PMID 29849457 · DOI 10.2147/ijn.s158696 -
Progress in Polymeric Micelles for Drug Delivery Applications.
Kotta S, Aldawsari HM, Badr-Eldin SM, Nair AB, et al · · 2022 · cited 113× · PMID 36015262 · DOI 10.3390/pharmaceutics14081636 -
Stimuli-Responsive Polymeric Nanoplatforms for Cancer Therapy.
Chang D, Ma Y, Xu X, Xie J, et al · · 2021 · cited 69× · PMID 34249894 · DOI 10.3389/fbioe.2021.707319 -
Polymeric Micellar Systems-A Special Emphasis on "Smart" Drug Delivery.
Negut I, Bita B. · · 2023 · cited 66× · PMID 36986837 · DOI 10.3390/pharmaceutics15030976
Verify or expand the search:
- PubMed search for NCT02639858
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Docetaxel-PM
Trials testing the same drug.
- NCT03585673 — Docetaxel-polymeric Micelles(PM) and Oxaliplatin for Esophageal Carcinoma · Phase 2 · unknown
Other recruiting trials for Head and Neck Squamous Cell Carcinoma
Currently open trials in the same condition.
- NCT06980038 — Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone i · Phase 2 · recruiting
- NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
- NCT06995508 — Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial · Phase 2 · recruiting
- NCT07254585 — SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma · Phase 2 · recruiting
- NCT07514754 — Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients · NA · recruiting
Other Samyang Biopharmaceuticals Corporation trials
Trials by the same sponsor.
- NCT07467239 — A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds · NA · recruiting
- NCT06961448 — A Study in Adults Evaluating Polycaprolactone Microsphere Filler for Treatment of Moderate to Severe Nasolabial Folds · NA · not yet recruiting
- NCT06402058 — A Study Comparing DMSB01 and Rejuran® for Temporary Crow's Feet Lines Improvement · NA · not yet recruiting
- NCT06295172 — A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement · NA · not yet recruiting
- NCT06093321 — A Study Comparing SYB PDO Thread and MINT Lift® for Temporary Nasolabial Fold Improvement · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02639858 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Samyang Biopharmaceuticals Corporation
- Last refreshed: 27 April 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02639858.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing