7 completed, 2 terminated, 2 withdrawn, 1 unknown. 7 Phase 3, 2 Phase 1, 2 Phase 2, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 7 | Completed 3, Terminated 2, Withdrawn 2 |
| Phase 1 | 2 | Completed 2 |
| Phase 2 | 2 | Completed 1, Unknown 1 |
| Not applicable | 1 | Completed 1 |
Follow proxalutamide: new trials by email Literature Review of proxalutamide trials Research Report on proxalutamide
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects GT0918, Standard of care, Matching placebo - Covid19 | Phase 3 | Terminated | Suzhou Kintor Pharmaceutical Inc, | 139 | 2021-09-30 | 2023-08-18 |
| A Phase 3 Randomized, Double-Blind Placebo Controlled, Multi-regional Trial to Evaluate the Efficacy and Safety of GT0918 for the Treatment of Mild to Moderate COVID-19 Male Patients GT0918 tablets or placebo - COVID-19 | Phase 3 | Terminated | Suzhou Kintor Pharmaceutical Inc, | 380 | 2021-08-04 | 2023-08-18 |
| Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for High Risk Prostate Cancer placebo, Proxalutamide - Neoadjuvant Therapy \High Risk Prostate Cancer | Phase 2 | Unknown | Hongqian Guo | 2 | 2021-06-17 | 2021-10-13 |
| The South Proxa-Rescue AndroCoV Trial Against COVID-19 Proxalutamide, Placebo - COVID-19 | Phase 3 | Completed | Corpometria Institute | 133 | 2021-03-06 | 2021-11-19 |
| Proxalutamide (GT0918) Treatment for Outpatients With Mild or Moderate COVID-19 Illness Proxalutamide (GT0918), Placebo - Efficacy and Safety | Phase 3 | Completed | Suzhou Kintor Pharmaceutical Inc, | 733 | 2021-03-05 | 2024-01-02 |
| Proxalutamide Treatment for COVID-19 Patients in Intensive Care Unit Proxalutamide, Placebo - Covid19, SARS (Severe Acute Respiratory Syndrome) | Phase 3 | Withdrawn | Applied Biology, Inc. | 2021-02-08 | 2022-03-04 | |
| Proxalutamide Treatment for Hospitalized COVID-19 Patients Proxalutamide, Placebo - Covid19, SARS (Severe Acute Respiratory Syndrome) | Phase 3 | Completed | Applied Biology, Inc. | 645 | 2021-02-01 | 2021-06-24 |
| Proxalutamide Treatment for COVID-19 Female Outpatients Proxalutamide, Standard of Care - Covid19, SARS-CoV Infection | Phase 3 | Withdrawn | Applied Biology, Inc. | 2020-11-01 | 2022-03-04 | |
| Anti-Androgen Treatment for COVID-19 Proxalutamide, Standard of Care - COVID-19, SARS-CoV2 | Not applicable | Completed | Applied Biology, Inc. | 268 | 2020-10-21 | 2021-12-10 |
| The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC GT0918 - Metastatic Castrate Resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) | Phase 2 | Completed | Suzhou Kintor Pharmaceutical Inc, | 61 | 2019-05-30 | 2024-02-12 |
| Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer Proxalutamide - Metastatic Breast Cancer | Phase 1 | Completed | Suzhou Kintor Pharmaceutical Inc, | 63 | 2017-09-06 | 2021-09-24 |
| Safety, Tolerability, and PK of GT0918 (Proxalutamide) in Subjects With Metastatic Castrate Prostate Cancer GT0918 - Metastatic Castrate Resistant Prostate Cancer (mCRPC) | Phase 1 | Completed | Suzhou Kintor Pharmaceutical Inc, | 40 | 2016-02-10 | 2020-03-17 |
COVID-19 (7) · Severe Acute Respiratory Syndrome (4) · Alopecia (1) · Breast Neoplasms (1) · Prostatic Hyperplasia (1) · Prostatic Neoplasms (1)
Suzhou Kintor Pharmaceutical Inc, (6) · Applied Biology, Inc. (4) · Corpometria Institute (1) · Hongqian Guo (1)
Brazil (6) · United States (4) · China (3) · Philippines (1) · South Africa (1) · Ukraine (1)
Andy Goren, MD (3) · Flavio Cadegiani, MD (3) · Carlos Wambier, MD (1) · Cristhieni Rodrigues (1) · Daniel Fonseca, MD (1) · Flavio A Cadegiani, MD (1) · Hongqian Guo, Phd (1) · Ke Chen (1) · Phoebe Zhang, PhD (1) · Wilson Lu (1)