Drugs / Leucovorin
Leucovorin
DrugLeucovorin (folinic acid) is a reduced folate medicine used to decrease toxic effects from folate antagonists and in combination oncology regimens. It is also used in megaloblastic anemia and selected folate-related disorders. U.S. regulatory materials include modern approvals for specific tablet indications such as cerebral folate deficiency.
- Trials
- 1336
- Recruiting
- 164
- Completed
- 642
- With results
- 319
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | Approved for marketing | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | 1 | — | — | 2 | 4 | 2 | — | — | 1 | — | 10 |
| Phase 1 | 26 | 2 | — | 15 | 117 | 18 | 5 | — | 6 | — | 189 |
| Phase 1/2 | 20 | 8 | — | 7 | 40 | 18 | 16 | — | 6 | — | 115 |
| Phase 2 | 66 | 18 | 1 | 44 | 291 | 87 | 28 | 2 | 85 | — | 622 |
| Phase 2/3 | 2 | 2 | — | 6 | 13 | 3 | 5 | — | 6 | — | 37 |
| Phase 3 | 43 | 17 | — | 24 | 149 | 20 | 2 | 1 | 49 | — | 305 |
| Phase 4 | 2 | 2 | — | — | 5 | — | — | 1 | 2 | — | 12 |
| Not applicable | 3 | 1 | 1 | 1 | 21 | 4 | 2 | — | 5 | — | 38 |
| Unknown | 1 | — | — | 1 | 2 | 1 | — | — | 2 | 1 | 8 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Colorectal Neoplasms | 1 | 56 | 36 | 203 | 10 | 129 | 6 | 6 | 2 | 449 |
| Rectal Neoplasms | — | 29 | 8 | 105 | 4 | 56 | 1 | 5 | — | 208 |
| Colonic Neoplasms | 2 | 29 | 10 | 78 | 5 | 71 | 1 | 5 | 1 | 202 |
| Pancreatic Neoplasms | 3 | 28 | 19 | 55 | 2 | 22 | — | 1 | 2 | 132 |
| Stomach Neoplasms | — | 17 | 7 | 66 | 5 | 17 | 2 | 5 | 1 | 120 |
| Neoplasm Metastasis | — | 19 | 6 | 50 | — | 22 | 1 | — | — | 98 |
| Neoplasms | — | 21 | 6 | 25 | 2 | 10 | — | — | 1 | 65 |
| Esophageal Neoplasms | — | 8 | 6 | 34 | 1 | 5 | — | 2 | 1 | 57 |
| Precursor Cell Lymphoblastic Leukemia-Lymphoma | — | 8 | 7 | 19 | 1 | 14 | — | 2 | — | 51 |
| Lymphoma | — | 7 | 1 | 24 | 1 | 10 | — | 6 | — | 49 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | National Cancer Institute (NCI) | 79 | 21 |
| 2 | Sun Yat-sen University | 32 | 16 |
| 3 | Alliance for Clinical Trials in Oncology | 30 | 13 |
| 4 | Memorial Sloan Kettering Cancer Center | 30 | 0 |
| 5 | Children's Oncology Group | 27 | 16 |
| 6 | M.D. Anderson Cancer Center | 24 | 1 |
| 7 | Hoffmann-La Roche | 21 | 7 |
| 8 | ImmunityBio, Inc. | 20 | 0 |
| 9 | UNICANCER | 20 | 8 |
| 10 | GERCOR - Multidisciplinary Oncology Cooperative Group | 19 | 6 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Leucovorin | 1336 |
| 2 | Fluorouracil | 1042 |
| 3 | Oxaliplatin | 736 |
| 4 | Irinotecan | 422 |
| 5 | Bevacizumab | 253 |
| 6 | Capecitabine | 186 |
| 7 | Methotrexate | 162 |
| 8 | Cyclophosphamide | 127 |
| 9 | Gemcitabine | 125 |
| 10 | Cetuximab | 115 |
Evidence
- Results reported
- 49.7%319 of 642 completed
- Published
- 22%141 of 642 completed
- Primary endpoint met
- 41.6%69 of 166 analyses
- Median months to report
- 19
Documents disclosed
Trial profile
- Median enrollment
- 75
- Median duration
- 56.7months
- Countries
- 71
- Study sites
- 17881
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 17
- Phase 1
- 30
- Phase 1/2
- 40
- Phase 2
- 53
- Phase 2/3
- 180
- Phase 3
- 413
- Phase 4
- 109
- Not applicable
- 96
- Unknown
- 184
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | New York | United States | 226 |
| 2 | Chicago | United States | 176 |
| 3 | Los Angeles | United States | 172 |
| 4 | Houston | United States | 161 |
| 5 | Boston | United States | 158 |
| 6 | St Louis | United States | 153 |
| 7 | Philadelphia | United States | 149 |
| 8 | Rochester | United States | 145 |
| 9 | Nashville | United States | 139 |
| 10 | Seattle | United States | 127 |
Terminations
- Terminated
- 153
- Withdrawn
- 58
- Suspended
- 4
- Stopped for recruitment
- 4.6%61 of 1336 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 |
|---|---|---|---|
| NCT05062889 Suspended | Suspended | due to earlier termination of the agreement between the Sponsor and Central Laboratory for screening test. Enrollment will reopen as soon as a new laboratory is identified. | 2029-12-31 |
| NCT05358704 Suspended | Suspended | no slots available | 2028-01-30 |
| NCT03203525 Terminated | Terminated | \<75% participation | 2026-07-22 |
| NCT02366819 Suspended | Suspended | Pending data analysis | 2026-06-08 |
| NCT04488159 Withdrawn | Withdrawn | Lack of funding. | 2026-06-01 |
| NCT04949256 Terminated | Terminated | Trial was rendered as cancelled work ongoing in the book of business. | 2026-05-20 |
| NCT06704724 Terminated | Terminated | The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns. | 2026-05-12 |
| NCT05083481 Terminated | Terminated | Lack of clinical benefit | 2026-05-11 |
| NCT04481204 Withdrawn | Withdrawn | 0 participants | 2026-04-27 |
| NCT05712356 Terminated | Terminated | The study was halted prematurely to allow analysis of the results. | 2026-04-05 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: