Drugs / Sorafenib
Sorafenib
DrugSorafenib is marketed as Nexavar, an oral multikinase inhibitor indicated for unresectable hepatocellular carcinoma, advanced renal cell carcinoma, and radioactive iodine-refractory differentiated thyroid carcinoma. The label describes inhibition of multiple intracellular and cell-surface kinases involved in tumor proliferation and angiogenesis. U.S. initial approval was in 2005.
- Trials
- 701
- Recruiting
- 16
- Completed
- 440
- With results
- 225
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | — | — | — | 2 | 1 | — | — | — | 3 |
| Phase 1 | — | — | 5 | 118 | 18 | 8 | — | 3 | 152 |
| Phase 1/2 | 1 | — | 1 | 48 | 10 | 4 | 1 | 9 | 74 |
| Phase 2 | 11 | 1 | 9 | 177 | 53 | 12 | — | 35 | 298 |
| Phase 2/3 | 1 | 1 | — | 4 | 1 | — | 1 | 6 | 14 |
| Phase 3 | 1 | — | 6 | 51 | 11 | 2 | — | 11 | 82 |
| Phase 4 | — | — | — | 4 | 2 | — | — | 6 | 12 |
| Not applicable | — | — | — | 8 | 7 | 1 | — | 7 | 23 |
| Unknown | 2 | — | 1 | 28 | 3 | 1 | — | 8 | 43 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Carcinoma, Hepatocellular | 2 | 37 | 26 | 65 | 8 | 41 | 9 | 11 | 18 | 217 |
| Carcinoma, Renal Cell | 1 | 9 | 5 | 38 | — | 12 | 1 | 2 | 15 | 83 |
| Liver Neoplasms | — | 20 | 7 | 20 | 3 | 8 | 2 | 1 | 7 | 68 |
| Neoplasms | — | 17 | 7 | 15 | — | 11 | 1 | 2 | — | 53 |
| Leukemia, Myeloid, Acute | — | 13 | 6 | 10 | 2 | 2 | — | — | 3 | 36 |
| Neoplasm Metastasis | — | 11 | — | 17 | — | 4 | 1 | 1 | — | 34 |
| Carcinoma, Non-Small-Cell Lung | — | 9 | 3 | 16 | — | 4 | — | — | 1 | 33 |
| Breast Neoplasms | — | 6 | 5 | 15 | — | 1 | — | 2 | — | 29 |
| Melanoma | — | 7 | 2 | 13 | — | 2 | — | — | — | 24 |
| Kidney Neoplasms | 1 | 5 | 3 | 8 | — | 3 | — | 1 | 1 | 22 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | National Cancer Institute (NCI) | 83 | 6 |
| 2 | Bayer | 78 | 17 |
| 3 | M.D. Anderson Cancer Center | 24 | 0 |
| 4 | Sun Yat-sen University | 19 | 8 |
| 5 | Memorial Sloan Kettering Cancer Center | 10 | 0 |
| 6 | SCRI Development Innovations, LLC | 10 | 0 |
| 7 | Nanfang Hospital, Southern Medical University | 8 | 3 |
| 8 | University Health Network, Toronto | 8 | 0 |
| 9 | Fudan University | 7 | 0 |
| 10 | St. Jude Children's Research Hospital | 7 | 0 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Sorafenib | 701 |
| 2 | Bevacizumab | 41 |
| 3 | Everolimus | 32 |
| 4 | Gemcitabine | 31 |
| 5 | Cisplatin | 27 |
| 6 | Erlotinib Hydrochloride | 25 |
| 7 | Oxaliplatin | 22 |
| 8 | Capecitabine | 21 |
| 9 | Carboplatin | 21 |
| 10 | Sunitinib | 20 |
Evidence
- Results reported
- 51.1%225 of 440 completed
- Published
- 14.5%64 of 440 completed
- Primary endpoint met
- 40%22 of 55 analyses
- Median months to report
- 19
Documents disclosed
Trial profile
- Median enrollment
- 44
- Median duration
- 48months
- Countries
- 74
- Study sites
- 7619
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 12
- Phase 1
- 23
- Phase 1/2
- 37
- Phase 2
- 41
- Phase 2/3
- 108
- Phase 3
- 386
- Phase 4
- 94
- Not applicable
- 45
- Unknown
- 120
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | New York | United States | 76 |
| 2 | Houston | United States | 69 |
| 3 | Philadelphia | United States | 64 |
| 4 | Guangzhou | China | 60 |
| 5 | Boston | United States | 57 |
| 6 | Chicago | United States | 57 |
| 7 | Seoul | South Korea | 57 |
| 8 | Los Angeles | United States | 56 |
| 9 | Shanghai | China | 49 |
| 10 | London | United Kingdom | 43 |
Terminations
- Terminated
- 106
- Withdrawn
- 28
- Suspended
- 2
- Stopped for recruitment
- 5.7%40 of 701 trials
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT05033522 Suspended | Suspended | Sponsor unable to fund | 2026-12-01 |
| NCT06474663 Withdrawn | Withdrawn | 0 participants | 2025-07-31 |
| NCT04709380 Terminated | Terminated | IDMC recommended to terminate the study since Interim analysis showed that the experimental group had significant superiority over the control group in TTP and OS (p\<0.001), meeting the predefined interim analysis endpoints in the study protocol. | 2025-02-05 |
| NCT04465734 Withdrawn | Withdrawn | The trial used sorafenib as a control drug. It's not suitable now(after the A+T has been approved).The sponsor terminated the trial. | 2024-03-15 |
| NCT03582618 Terminated | Terminated | The study has been terminated due to slow enrollment | 2022-12-30 |
| NCT01608139 Withdrawn | Withdrawn | 2022-11-30 | |
| NCT04326439 Terminated | Terminated | Due to unforeseen circumstances, the study team was limited in enrolling patients on this trial; thus, it was terminated. | 2022-03-15 |
| NCT03236649 Terminated | Terminated | Because the clinical development plan has been changed. | 2022-02-08 |
| NCT04985136 Terminated | Terminated | Sponsor R \& D Strategy Adjustment | 2021-12-29 |
| NCT03780634 Withdrawn | Withdrawn | No participants enrolled | 2021-12-01 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: