Drugs / Axitinib
Axitinib Clinical Trials
DrugAxitinib is a small-molecule tyrosine kinase inhibitor developed for oncology and marketed as Inlyta. It is approved for renal cell carcinoma and is used as an oral targeted anti-cancer therapy. The medicine is prescription-only.
Continuously tracked·last revised
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Recruiting Phase 3
Recently started
| Trial | Phase | Status | Sponsor | Started |
|---|---|---|---|---|
| MANTIS-RCC: Toripalimab-Axitinib Induction in TLS-Positive Advanced Non-Clear Cell and Renal Medullary Carcinomas NCT07816770 | Phase 2 | Not yet recruiting | Fudan University | Started 2026-09 |
| TACTIC-RCC: Toripalimab Plus Axitinib Induction With Selective Deferred Cytoreductive Nephrectomy in TLS-Positive Advanced Clear Cell Renal Cell Carcinoma NCT07776717 | Phase 2 | Not yet recruiting | Fudan University | Started 2026-08 |
| SABR Combined With Axitinib and Toripalimab for Oligometastatic Renal Cell Carcinoma NCT07744932 | Phase 2 | Recruiting | Hebei Medical University Fourth Hospital | Started 2026-08 |
| Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer NCT07383441 | Phase 3 | Recruiting | SWOG Cancer Research Network | Started 2026-06 |
| PTC-Guided Atorvastatin Plus Axitinib and Toripalimab in Advanced RCC NCT07630363 | Phase 1/2 | Not yet recruiting | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Started 2026-05 |
Results recently posted
| Trial | Phase | Status | Sponsor | Results posted |
|---|---|---|---|---|
| A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors NCT05949632 | Phase 1/2 | Terminated | Incyte Corporation | Results posted 2026-06-04 |
| SLM + Axitinib for Clear Cell RCC NCT02535533 | Phase 1/2 | Completed | Mohammed Milhem | Results posted 2026-05-06 |
| Sandostatin LAR and Axitinib vs Pbo in Pnts With Advanced Well-differentiated Non-pancreatic Neuroendocrine Carcinomas NCT01744249 | Phase 2/3 | Completed | Grupo Espanol de Tumores Neuroendocrinos | Results posted 2026-04-28 |
| Axitinib Monotherapy With Early Dynamic Contrast Enhanced Ultrasound Monitoring in Chemorefractory Third Line Metastatic Colorectal Cancer NCT04355156 | Phase 2 | Completed | Imperial College London | Results posted 2026-04-16 |
| Duvelisib in Combination With Nivolumab in Patients With Advanced Unresectable Melanoma NCT04688658 | Phase 1/2 | Terminated | John Kirkwood | Results posted 2025-12-17 |
Pipeline
Phase by status
| Phase | Recruiting | Not yet | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | No longer available | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 | 1 | — | 1 | 25 | 3 | 3 | — | 1 | — | 34 |
| Phase 1/2 | 1 | 1 | 3 | 7 | 5 | 1 | — | — | — | 18 |
| Phase 2 | 16 | 5 | 7 | 54 | 11 | 4 | 1 | 13 | — | 111 |
| Phase 2/3 | — | — | 1 | 1 | — | — | — | 1 | — | 3 |
| Phase 3 | 3 | — | 2 | 5 | 1 | — | — | — | — | 11 |
| Not applicable | — | 1 | — | 3 | — | — | — | 1 | — | 5 |
| Unknown | 1 | — | — | 11 | — | 1 | — | — | 3 | 16 |
Trials started per year
Conditions studied, by phase
| Condition | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|
| Carcinoma, Renal Cell | 7 | 7 | 37 | — | 6 | 2 | 9 | 68 |
| Kidney Neoplasms | 1 | 3 | 8 | — | 4 | — | 2 | 18 |
| Neoplasms | 8 | — | 6 | — | 1 | — | 1 | 16 |
| Carcinoma, Non-Small-Cell Lung | 1 | 3 | 6 | — | — | — | — | 10 |
| Neoplasm Metastasis | 2 | 2 | 6 | — | — | — | — | 10 |
| Carcinoma | 2 | 1 | 3 | — | — | — | 2 | 8 |
| Carcinoma, Hepatocellular | 3 | — | 5 | — | — | — | — | 8 |
| Colorectal Neoplasms | 2 | 1 | 4 | — | — | 1 | — | 8 |
| Clear-cell metastatic renal cell carcinoma | — | 2 | 4 | — | 1 | — | — | 7 |
| Melanoma | 2 | — | 5 | — | — | — | — | 7 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Pfizer | 52 | 5 |
| 2 | M.D. Anderson Cancer Center | 5 | 0 |
| 3 | National Cancer Institute (NCI) | 4 | 0 |
| 4 | Peking University Cancer Hospital & Institute | 4 | 0 |
| 5 | Chinese University of Hong Kong | 3 | 0 |
| 6 | Fudan University | 3 | 0 |
| 7 | H. Lee Moffitt Cancer Center and Research Institute | 3 | 0 |
| 8 | Memorial Sloan Kettering Cancer Center | 3 | 0 |
| 9 | RenJi Hospital | 3 | 0 |
| 10 | The Netherlands Cancer Institute | 3 | 0 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Axitinib | 198 |
| 2 | avelumab | 24 |
| 3 | pembrolizumab | 22 |
| 4 | toripalimab | 15 |
| 5 | Sunitinib | 13 |
| 6 | Nivolumab | 12 |
| 7 | Bevacizumab | 9 |
| 8 | lenvatinib | 9 |
| 9 | Ipilimumab | 8 |
| 10 | cabozantinib | 7 |
Terminations
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 |
|---|---|---|---|
| NCT06161558 Withdrawn | Withdrawn | Lack of resources to complete study objectives. No participants enrolled. | 2025-07-15 |
| NCT05949632 Terminated | Terminated | This was a strategic business decision. There were no safety concerns contributing to this decision. | 2025-06-06 |
| NCT04370509 Terminated | Terminated | Collaborating sponsor decision | 2025-02-28 |
| NCT04688658 Terminated | Terminated | Secura Bio, Inc. discontinued support of the trial. | 2025-02-01 |
| NCT04458259 Terminated | Terminated | Pfizer has made an internal business decision to not continue further development of PF-07265807. This decision was not due to major safety concerns or requests from any regulatory authorities. | 2024-11-15 |
| NCT04585815 Terminated | Terminated | Study was terminated due to portfolio re-prioritization and strategic considerations. The decision was not based on any safety concerns and/or regulatory interactions | 2024-10-29 |
| NCT05097599 Terminated | Terminated | Business decision and enrollment difficulties | 2024-06-12 |
| NCT04873895 Terminated | Terminated | failure to accrue | 2024-04-25 |
| NCT03472560 Terminated | Terminated | The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the Investigational treatments have been moved to a continuation study (NCT05059522) | 2023-02-09 |
| NCT05249569 Terminated | Terminated | Sponsor pulled support for one of the study drugs. | 2022-12-30 |
Evidence
- Results reported
- 75.5%80 of 106 completed
- Published
- 3.8%4 of 106 completed
- Primary endpoint met
- 37.9%11 of 29 analyses
- Median months to report
- 12
Documents disclosed
Trial profile
- Median enrollment
- 41
- Median duration
- 46.1months
- Countries
- 44
- Study sites
- 3008
Who is enrolled
Median enrollment by phase
- Phase 1
- 30
- Phase 1/2
- 43
- Phase 2
- 39
- Phase 2/3
- 256
- Phase 3
- 718
- Not applicable
- 43
- Unknown
- 228
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Houston | United States | 27 |
| 2 | New York | United States | 27 |
| 3 | Boston | United States | 20 |
| 4 | Cleveland | United States | 19 |
| 5 | Madrid | Spain | 18 |
| 6 | Seoul | South Korea | 18 |
| 7 | Nashville | United States | 17 |
| 8 | Philadelphia | United States | 17 |
| 9 | Beijing | China | 16 |
| 10 | Dallas | United States | 16 |