Drugs / Methotrexate
Methotrexate
DrugMethotrexate is a cytotoxic antimetabolite drug used across oncology and immune-mediated diseases in indication-specific dosing regimens, often once weekly in non-oncology uses. Labeling requires careful dose scheduling because medication errors can cause fatal toxicity. Initial U.S. approval dates to 1953.
- Trials
- 1437
- Recruiting
- 133
- Completed
- 826
- With results
- 464
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | 4 | — | 1 | 1 | 7 | — | 1 | — | 2 | 16 |
| Phase 1 | 10 | — | — | 8 | 72 | 9 | 4 | — | 8 | 111 |
| Phase 1/2 | 6 | — | — | 4 | 32 | 14 | 5 | — | 7 | 68 |
| Phase 2 | 53 | 15 | — | 26 | 279 | 74 | 18 | — | 59 | 524 |
| Phase 2/3 | 9 | 2 | — | 3 | 13 | 4 | — | 1 | 12 | 44 |
| Phase 3 | 23 | 1 | — | 16 | 238 | 23 | 4 | 1 | 32 | 338 |
| Phase 4 | 15 | 8 | — | 3 | 109 | 13 | 6 | — | 38 | 192 |
| Not applicable | 7 | 2 | — | 2 | 47 | 9 | 2 | — | 22 | 91 |
| Unknown | 6 | 3 | 1 | 1 | 29 | — | — | — | 13 | 53 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Arthritis, Rheumatoid | 1 | 21 | 3 | 61 | 8 | 93 | 78 | 10 | 11 | 286 |
| Precursor Cell Lymphoblastic Leukemia-Lymphoma | 1 | 25 | 22 | 106 | 12 | 48 | 18 | 14 | 4 | 250 |
| Leukemia | — | 11 | 18 | 98 | 6 | 41 | — | 10 | 2 | 186 |
| Lymphoma | 1 | 8 | 10 | 79 | 4 | 21 | 1 | 13 | — | 137 |
| Leukemia, Myeloid, Acute | — | 17 | 12 | 52 | 2 | 16 | — | 5 | — | 104 |
| Burkitt Lymphoma | 1 | 8 | 8 | 53 | 3 | 13 | 2 | 4 | — | 92 |
| Myelodysplastic Syndromes | — | 10 | 10 | 41 | 1 | 11 | — | 6 | — | 79 |
| Lymphoma, Non-Hodgkin | — | 5 | 5 | 40 | — | 7 | — | 7 | — | 64 |
| Graft vs Host Disease | — | 3 | 7 | 29 | 1 | 15 | 3 | 5 | — | 63 |
| Breast Neoplasms | — | 2 | 2 | 23 | 1 | 28 | — | 3 | 1 | 60 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Children's Oncology Group | 57 | 31 |
| 2 | M.D. Anderson Cancer Center | 57 | 2 |
| 3 | National Cancer Institute (NCI) | 49 | 14 |
| 4 | Hoffmann-La Roche | 48 | 27 |
| 5 | Fred Hutchinson Cancer Center | 43 | 3 |
| 6 | St. Jude Children's Research Hospital | 38 | 7 |
| 7 | Memorial Sloan Kettering Cancer Center | 21 | 1 |
| 8 | Dana-Farber Cancer Institute | 20 | 4 |
| 9 | Bristol-Myers Squibb | 19 | 10 |
| 10 | Alliance for Clinical Trials in Oncology | 17 | 1 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Methotrexate | 1437 |
| 2 | Cyclophosphamide | 424 |
| 3 | Cytarabine | 352 |
| 4 | Vincristine | 317 |
| 5 | Dexamethasone | 240 |
| 6 | Doxorubicin | 240 |
| 7 | Etoposide | 188 |
| 8 | Mercaptopurine | 178 |
| 9 | Prednisone | 174 |
| 10 | Rituximab | 170 |
Evidence
- Results reported
- 56.2%464 of 826 completed
- Published
- 19.2%159 of 826 completed
- Primary endpoint met
- 61.5%236 of 384 analyses
- Median months to report
- 16
Documents disclosed
Trial profile
- Median enrollment
- 76
- Median duration
- 54.3months
- Countries
- 89
- Study sites
- 14940
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 25
- Phase 1
- 24
- Phase 1/2
- 36
- Phase 2
- 50
- Phase 2/3
- 132
- Phase 3
- 265
- Phase 4
- 100
- Not applicable
- 53
- Unknown
- 222
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Houston | United States | 212 |
| 2 | New York | United States | 186 |
| 3 | Boston | United States | 162 |
| 4 | Seattle | United States | 160 |
| 5 | Chicago | United States | 158 |
| 6 | Philadelphia | United States | 156 |
| 7 | Dallas | United States | 142 |
| 8 | St Louis | United States | 141 |
| 9 | Cleveland | United States | 135 |
| 10 | Los Angeles | United States | 134 |
Terminations
- Terminated
- 146
- Withdrawn
- 40
- Suspended
- 2
- Stopped for recruitment
- 4.5%64 of 1437 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 |
|---|---|---|---|
| NCT05691478 Suspended | Suspended | Other - Extend the observation period for current patients | 2030-03-20 |
| NCT06015750 Withdrawn | Withdrawn | Sponsor decision following FDA release from the PMR. | 2030-03-13 |
| NCT04961801 Withdrawn | Withdrawn | Manufacturer AstraZeneca withdrew the study due to lack of funding | 2030-01-31 |
| NCT04845035 Withdrawn | Withdrawn | The PI plans to revise the study design in a new protocol | 2029-01-31 |
| NCT07498465 Withdrawn | Withdrawn | Other - Protocol moved to Withdrawn | 2028-11-12 |
| NCT06466798 Withdrawn | Withdrawn | Inability to find participants meeting eligibility critieria | 2027-07-01 |
| NCT06210750 Withdrawn | Withdrawn | Other - Protocol moved to Disapproved | 2026-09-22 |
| NCT06578728 Terminated | Terminated | The study was terminated due to slow accrual. | 2026-06-05 |
| NCT03808610 Terminated | Terminated | \<75% participation | 2026-05-05 |
| NCT03719560 Withdrawn | Withdrawn | lack of funding | 2025-12-31 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: