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- ||| Varubi (rolapitant oral) / TerSera Therap, GSK, HR20013 / Jiangsu Hengrui Pharma, Varubi IV (rolapitant IV) / TerSera Therap, GSK
P3 data, Journal, CINV: Randomized, Phase III Trial of Mixed Formulation of Fosrolapitant and Palonosetron (HR20013) in Preventing Cisplatin-Based Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: PROFIT. (Pubmed Central) - Dec 2, 2024
HR20013 + DEX was noninferior to FAPR + PALO + DEX for preventing HEC-CINV and well tolerated, with the potential to reduce the impact of CINV on daily life.
- |||||| HR20013 / Jiangsu Hengrui Pharma
Enrollment open, Trial primary completion date: HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents (clinicaltrials.gov) - Sep 19, 2024
P3, N=700, Recruiting, Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
HR20013 + DEX was noninferior to FAPR + PALO + DEX for preventing HEC-CINV and well tolerated, with the potential to reduce the impact of CINV on daily life. Not yet recruiting --> Recruiting | Trial primary completion date: Jun 2025 --> Sep 2025
- |||||||||| HR20013 / Jiangsu Hengrui Pharma
New P3 trial: HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents (clinicaltrials.gov) - Aug 15, 2024
P3, N=700, Not yet recruiting, Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
- HR20013 / Jiangsu Hengrui Pharma
Phase 3 Study of HR20013 For Prevention of Cisplatin-based Chemotherapy-induced Nausea and Vomiting (PROFIT Study) (30BC) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_879;
P3
The study (NCT05509634) aimed to assess HR20013 versus fosaprepitant (FAPR) plus PALO (FAPR+PALO) regimen in preventing cisplatin-based HEC-CINV...All pts also received oral dexamethasone (DEX) on days 1-4...CR Cycle 1 Cycle 2 HR20013+DEX (N=373) FAPR+PALO+DEX (N=377) D P HR20013+DEX (N=314) FAPR+PALO+DEX (N=336) D P OP 290 (77.7) 295 (78.2) -0.9 (-6.7, 5.0) <0.01 * 254 (80.9) 263 (78.3) 2.4 (-3.7, 8.5) 0.44 AP 340 (91.2) 339 (89.9) 1.0 (-3.2, 5.2) 0.64 293 (93.3) 306 (91.1) 2.2 (-1.9, 6.2) 0.30 DP 298 (79.9) 304 (80.6) -1.2 (-6.8, 4.4) 0.68 255 (81.2) 267 (79.5) 1.5 (-4.5, 7.6) 0.62 BDP 337 (90.3) 326 (86.5) 3.7 (-0.9, 8.2) 0.11 291 (92.7) 295 (87.8) 4.8 (0.3, 9.2) 0.04 0-168 h 285 (76.4) 283 (75.1) 1.0 (-5.1, 7.0) 0.75 250 (79.6) 256 (76.2) 3.2 (-3.0, 9.5) 0.32 Data are n (%) or % (95% CI). * Only P for primary endpoint was 1-sided for the noninferiority test.
- ||||||| HR20013 / Jiangsu Hengrui Pharma
Trial completion: Clinical Study of HR20013 for Injection in Patients With Malignant Solid Tumors (clinicaltrials.gov) - Sep 13, 2023
P3, N=754, Completed, Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
* Only P for primary endpoint was 1-sided for the noninferiority test. Active, not recruiting --> Completed
- ||||| HR20013 / Jiangsu Hengrui Pharma
Enrollment closed: Clinical Study of HR20013 for Injection in Patients With Malignant Solid Tumors (clinicaltrials.gov) - Jul 6, 2023
P3, N=754, Active, not recruiting, Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || HR20013 / Jiangsu Hengrui Pharma
Trial completion: Study of HR20013 for Injection in Patients With Malignant Solid Tumors (clinicaltrials.gov) - Jan 20, 2023
P1, N=24, Completed, Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- || HR20013 / Jiangsu Hengrui Pharma
Enrollment closed, Trial completion date, Trial primary completion date: Study of HR20013 for Injection in Patients With Malignant Solid Tumors (clinicaltrials.gov) - Jan 12, 2023
P1, N=24, Active, not recruiting, Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial completion date: Sep 2022 --> Apr 2023 | Trial primary completion date: Sep 2022 --> Mar 2023
- |||||| HR20013 / Jiangsu Hengrui Pharma
Enrollment open: Clinical Study of HR20013 for Injection in Patients With Malignant Solid Tumors (clinicaltrials.gov) - Oct 25, 2022
P3, N=752, Recruiting, Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Recruiting --> Active, not recruiting | Trial completion date: Sep 2022 --> Apr 2023 | Trial primary completion date: Sep 2022 --> Mar 2023 Not yet recruiting --> Recruiting
- || HR20013 / Jiangsu Hengrui Pharma
Enrollment open: Study of HR20013 for Injection in Patients With Malignant Solid Tumors (clinicaltrials.gov) - Sep 8, 2022
P1, N=24, Recruiting, Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| HR20013 / Jiangsu Hengrui Pharma
New P3 trial: Clinical Study of HR20013 for Injection in Patients With Malignant Solid Tumors (clinicaltrials.gov) - Aug 22, 2022
P3, N=752, Not yet recruiting, Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
- || HR20013 / Jiangsu Hengrui Pharma
New P1 trial: Study of HR20013 for Injection in Patients With Malignant Solid Tumors (clinicaltrials.gov) - Jul 20, 2022
P1, N=24, Not yet recruiting, Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.