Zepsun (donafenib) / Suzhou Zelgen 
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 0 Diseases   13 Trials   13 Trials   91 News 


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  • ||||||||||  Zepsun (donafenib) / Suzhou Zelgen
    Phase classification, Enrollment change, Combination therapy, Metastases:  A Study of CS1001 in Combination With Donafenib in Subjects With Advanced Solid Tumors (clinicaltrials.gov) -  Jul 16, 2021   
    P1,  N=30, Recruiting, 
    Donafenib exhibited a better survival benefit than sorafenib in most of the baseline characteristic subgroups, which further confirmed the excellent efficacy of donafenib in the first-line treatment of advanced HCC. Phase classification: P1/2 --> P1 | N=120 --> 30
  • ||||||||||  Zepsun (donafenib) / Suzhou Zelgen, Nexavar (sorafenib) / Bayer, Amgen
    Clinical, Journal:  Donafenib treatment for hepatocellular carcinoma: A case report. (Pubmed Central) -  Jul 2, 2021   
    Donafenib showed good efficacy for the treatment of advanced HCC, with mild side effects. Deuterium-containing drugs seem to be a promising avenue for medical innovation.
  • ||||||||||  Zepsun (donafenib) / Suzhou Zelgen
    Enrollment open, Trial completion date, Trial primary completion date, Metastases:  Donafenib for Previously Treated Metastatic Colorectal Cancer (clinicaltrials.gov) -  May 24, 2021   
    P3,  N=536, Recruiting, 
    These adverse events could serve as predictors of the efficacy of donafenib in the treatment of advanced HCC. Completed --> Recruiting | Trial completion date: Apr 2020 --> Apr 2022 | Trial primary completion date: Apr 2020 --> Apr 2022
  • ||||||||||  Zepsun (donafenib) / Suzhou Zelgen
    Enrollment open, Trial initiation date, Combination therapy, Metastases:  A Study of CS1001 in Combination With Donafenib in Subjects With Advanced Solid Tumors (clinicaltrials.gov) -  May 13, 2021   
    P1/2,  N=120, Recruiting, 
    Completed --> Recruiting | Trial completion date: Apr 2020 --> Apr 2022 | Trial primary completion date: Apr 2020 --> Apr 2022 Not yet recruiting --> Recruiting | Initiation date: Apr 2021 --> Oct 2020
  • ||||||||||  Zepsun (donafenib) / Suzhou Zelgen
    Enrollment open, Trial initiation date, Metastases:  Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma (clinicaltrials.gov) -  May 2, 2021   
    P1/2,  N=46, Recruiting, 
    Not yet recruiting --> Recruiting | Initiation date: Apr 2021 --> Oct 2020 Not yet recruiting --> Recruiting | Initiation date: Apr 2021 --> Oct 2020
  • ||||||||||  donafenib (CM4307) / Suzhou Zelgen, Stivarga (regorafenib) / Bayer, Nexavar (sorafenib) / Bayer, Amgen
    Journal:  Study on Typical Diarylurea Drugs or Derivatives in Cocrystallizing with Strong H-Bond Acceptor DMSO. (Pubmed Central) -  Mar 9, 2021   
    Herein, seven related dimethyl sulfoxide (DMSO) complexes were screened from 12 substrates involving sorafenib and regorafenib, mainly considering the substitution effect following a robust procedure...Specially, five cocrystals with three deuterated, named sorafenib·DMSO, donafenib·DMSO, deuregorafenib·DMSO, 6·DMSO, and 7·DMSO were obtained...Cumulative data implied that the planarization of two aryl planes in diarylureas may play a crucial role in cocrystallization. Also, a polymorph study bridged the transformation between these ureas and their DMSO complexes.
  • ||||||||||  donafenib (CM4307) / Suzhou Zelgen
    Journal:  Inferior Vena Cava Tumor Thrombus From Thyroid Cancer Detected by 68Ga-PSMA-617 PET/CT. (Pubmed Central) -  Mar 4, 2021   
    A 61-year-old woman was diagnosed with progressive metastatic radioactive iodine refractory differentiated thyroid cancer and underwent multitargeted tyrosine kinase inhibitor (TKI) Donafenib therapy...68Ga-PSMA-617 PET/CT showed an intense radiotracer uptake in inferior vena cava, which was subsequently confirmed as tumor thrombus. Thus, this patient is a rare case in which the tumor thrombus from thyroid cancer was discovered in inferior vena cava via 68Ga-PSMA-617 PET/CT.
  • ||||||||||  Zepsun (donafenib) / Suzhou Zelgen
    Trial completion date, Trial primary completion date:  A Phase 3 Study of Donafenib in Patients With Radioiodine-refractory Differentiated Thyroid Cancer (clinicaltrials.gov) -  Oct 22, 2020   
    P3,  N=204, Recruiting, 
    Based on the results of this study, oral donafenib at 200 mg ~ 300 mg twice daily is recommended for further studies. Trial completion date: Mar 2021 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021
  • ||||||||||  Zepsun (donafenib) / Suzhou Zelgen
    Trial completion date, Trial primary completion date, Monotherapy, Metastases:  Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov) -  Oct 19, 2020   
    P1/2,  N=18, Recruiting, 
    Trial completion date: Mar 2021 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021 Trial completion date: Sep 2020 --> Sep 2023 | Trial primary completion date: Jun 2020 --> Jun 2023
  • ||||||||||  Zepsun (donafenib) / Suzhou Zelgen
    Trial completion date, Trial primary completion date, Monotherapy, Metastases:  Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer (clinicaltrials.gov) -  Oct 19, 2020   
    P1b,  N=17, Suspended, 
    Trial completion date: Sep 2020 --> Sep 2023 | Trial primary completion date: Jun 2020 --> Jun 2023 Trial completion date: Sep 2020 --> Sep 2023 | Trial primary completion date: Jun 2020 --> Jun 2023
  • ||||||||||  Zepsun (donafenib) / Suzhou Zelgen
    Trial primary completion date, Combination therapy, Metastases:  A Study of CS1001 in Combination With Donafenib in Subjects With Advanced Solid Tumors (clinicaltrials.gov) -  Oct 19, 2020   
    P1/2,  N=120, Not yet recruiting, 
    Trial completion date: Sep 2020 --> Sep 2023 | Trial primary completion date: Jun 2020 --> Jun 2023 Trial primary completion date: Sep 2022 --> Dec 2022
  • ||||||||||  Zepsun (donafenib) / Suzhou Zelgen
    Trial completion date, Trial primary completion date, Metastases:  Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma (clinicaltrials.gov) -  Oct 19, 2020   
    P1/2,  N=46, Not yet recruiting, 
    Trial primary completion date: Sep 2022 --> Dec 2022 Trial completion date: Sep 2022 --> Dec 2022 | Trial primary completion date: Aug 2022 --> Dec 2022
  • ||||||||||  Zepsun (donafenib) / Suzhou Zelgen
    Trial completion, Trial completion date, Metastases:  Donafenib for Previously Treated Metastatic Colorectal Cancer (clinicaltrials.gov) -  Jul 8, 2020   
    P3,  N=536, Completed, 
    Clinical trial identification: NCT02645981. Active, not recruiting --> Completed | Trial completion date: Oct 2020 --> Apr 2020
  • ||||||||||  Zepsun (donafenib) / Suzhou Zelgen
    Trial completion date, Trial primary completion date, Monotherapy, Metastases:  A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer (clinicaltrials.gov) -  Jul 2, 2020   
    P1b,  N=19, Suspended, 
    Active, not recruiting --> Completed | Trial completion date: Oct 2020 --> Apr 2020 Trial completion date: Aug 2020 --> Aug 2022 | Trial primary completion date: Mar 2020 --> Mar 2022
  • ||||||||||  Zepsun (donafenib) / Suzhou Zelgen
    Trial suspension, Trial primary completion date, Monotherapy, Metastases:  A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer (clinicaltrials.gov) -  Jan 6, 2020   
    P1b,  N=19, Suspended, 
    Active, not recruiting --> Completed Recruiting --> Suspended | Trial primary completion date: Dec 2019 --> Mar 2020
  • ||||||||||  Zepsun (donafenib) / Suzhou Zelgen
    Trial completion date, Trial primary completion date, Monotherapy, Metastases:  Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov) -  Jan 6, 2020   
    P1/2,  N=18, Recruiting, 
    Recruiting --> Suspended | Trial primary completion date: Dec 2019 --> Mar 2020 Trial completion date: Dec 2019 --> Sep 2020 | Trial primary completion date: Dec 2019 --> Jun 2020
  • ||||||||||  Zepsun (donafenib) / Suzhou Zelgen
    Trial completion date, Trial suspension, Trial primary completion date, Monotherapy, Metastases:  Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer (clinicaltrials.gov) -  Jan 6, 2020   
    P1b,  N=17, Suspended, 
    Trial completion date: Dec 2019 --> Sep 2020 | Trial primary completion date: Dec 2019 --> Jun 2020 Trial completion date: Dec 2019 --> Sep 2020 | Recruiting --> Suspended | Trial primary completion date: Dec 2019 --> Jun 2020