Drugs / Capecitabine
Capecitabine
DrugCapecitabine is an oral fluoropyrimidine antineoplastic agent used in breast, gastric, and colorectal cancers. It is converted in the body to 5-fluorouracil and is commonly used in combination regimens or selected monotherapy settings. It is marketed under brand names including Xeloda and is prescription-only.
- Trials
- 1909
- Recruiting
- 248
- Completed
- 756
- With results
- 391
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | Approved for marketing | No longer available | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | 1 | — | — | 1 | 1 | 1 | 1 | — | — | — | — | 5 |
| Phase 1 | 14 | 2 | — | 10 | 151 | 24 | 6 | — | 16 | — | — | 223 |
| Phase 1/2 | 22 | 9 | 1 | 11 | 59 | 35 | 17 | — | 27 | — | — | 181 |
| Phase 2 | 119 | 61 | — | 52 | 355 | 125 | 23 | 5 | 187 | — | — | 927 |
| Phase 2/3 | 8 | 7 | — | 7 | 13 | 5 | 2 | — | 19 | — | — | 61 |
| Phase 3 | 69 | 27 | — | 49 | 134 | 29 | 6 | 1 | 74 | — | — | 389 |
| Phase 4 | 4 | 5 | — | — | 13 | 4 | — | — | 6 | — | — | 32 |
| Not applicable | 6 | 2 | 1 | — | 10 | 7 | 1 | — | 14 | — | — | 41 |
| Unknown | 5 | 3 | 2 | 2 | 20 | 2 | — | — | 13 | 2 | 1 | 50 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Breast Neoplasms | 1 | 42 | 30 | 179 | 16 | 105 | 9 | 11 | 14 | 407 |
| Colorectal Neoplasms | — | 30 | 37 | 153 | 8 | 61 | 12 | 3 | 10 | 314 |
| Rectal Neoplasms | 1 | 31 | 17 | 120 | 4 | 42 | 3 | 6 | 9 | 233 |
| Stomach Neoplasms | — | 20 | 15 | 115 | 6 | 50 | 2 | 2 | 3 | 213 |
| Pancreatic Neoplasms | 2 | 30 | 19 | 59 | 4 | 14 | — | 4 | — | 132 |
| Neoplasm Metastasis | — | 17 | 16 | 60 | 4 | 21 | 2 | 1 | 2 | 123 |
| Colonic Neoplasms | 1 | 13 | 7 | 42 | 3 | 24 | 2 | 1 | 1 | 94 |
| Neoplasms | — | 26 | 12 | 28 | 3 | 12 | 1 | 3 | 1 | 86 |
| Triple Negative Breast Neoplasms | — | 4 | 8 | 34 | 1 | 19 | — | — | 1 | 67 |
| Esophageal Neoplasms | — | 12 | 8 | 28 | 3 | 5 | — | 1 | — | 57 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Hoffmann-La Roche | 91 | 21 |
| 2 | Fudan University | 73 | 19 |
| 3 | Sun Yat-sen University | 56 | 27 |
| 4 | National Cancer Institute (NCI) | 37 | 3 |
| 5 | M.D. Anderson Cancer Center | 30 | 1 |
| 6 | Merck Sharp & Dohme LLC | 25 | 16 |
| 7 | Alliance for Clinical Trials in Oncology | 22 | 4 |
| 8 | AstraZeneca | 19 | 10 |
| 9 | Asan Medical Center | 18 | 2 |
| 10 | ImmunityBio, Inc. | 18 | 0 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Capecitabine | 1909 |
| 2 | Oxaliplatin | 632 |
| 3 | Fluorouracil | 295 |
| 4 | Bevacizumab | 248 |
| 5 | Gemcitabine | 205 |
| 6 | Leucovorin | 186 |
| 7 | Cisplatin | 177 |
| 8 | Docetaxel | 175 |
| 9 | Irinotecan | 153 |
| 10 | Radiotherapy | 143 |
Evidence
- Results reported
- 51.7%391 of 756 completed
- Published
- 20.2%153 of 756 completed
- Primary endpoint met
- 39.1%59 of 151 analyses
- Median months to report
- 20
Documents disclosed
Trial profile
- Median enrollment
- 63
- Median duration
- 51.9months
- Countries
- 87
- Study sites
- 20947
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 10
- Phase 1
- 25
- Phase 1/2
- 45
- Phase 2
- 50
- Phase 2/3
- 260
- Phase 3
- 409
- Phase 4
- 100
- Not applicable
- 50
- Unknown
- 100
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Shanghai | China | 201 |
| 2 | Beijing | China | 193 |
| 3 | Guangzhou | China | 171 |
| 4 | Seoul | South Korea | 156 |
| 5 | Houston | United States | 144 |
| 6 | New York | United States | 144 |
| 7 | Madrid | Spain | 132 |
| 8 | Barcelona | Spain | 128 |
| 9 | Los Angeles | United States | 124 |
| 10 | Milan | Italy | 113 |
Terminations
- Terminated
- 232
- Withdrawn
- 56
- Suspended
- 6
- Stopped for recruitment
- 5.1%98 of 1909 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 |
|---|---|---|---|
| NCT06829199 Withdrawn | Withdrawn | Since patients were not recruited yet, we would mark this as a Withdrawn status per the NIH definition of that status. Study halted prematurely, prior to enrollment of first participant. | 2031-03-18 |
| NCT07057089 Suspended | Suspended | Suspended due to lack of drug supply: the manufacturer ceased to provide investigational drug supply. | 2030-12-01 |
| 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 |
| NCT06110598 Withdrawn | Withdrawn | PI left the institution | 2027-12-31 |
| NCT04488159 Withdrawn | Withdrawn | Lack of funding. | 2026-06-01 |
| NCT05238831 Withdrawn | Withdrawn | Withdrawn due to a change in therapeutic interventions. | 2026-05-31 |
| NCT02121405 Suspended | Suspended | DSMB stopped this trial due to the difference of 3-year DFS's rate between two groups more than 5% at the interim analysis in July 2021. | 2026-02-28 |
| NCT05296005 Withdrawn | Withdrawn | PI Decision | 2025-12-31 |
| NCT07040059 Terminated | Terminated | Patient recruitment problems. | 2025-12-29 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: