Drugs / Irinotecan
Irinotecan
DrugIrinotecan is an intravenous anti-cancer medicine used mainly for colon cancer and also for small cell lung cancer in combination regimens. It belongs to the topoisomerase inhibitor family and works through topoisomerase I blockade with downstream DNA damage and tumor cell death. It was approved for medical use in the United States in 1996.
- Trials
- 1304
- Recruiting
- 145
- Completed
- 654
- With results
- 267
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | — | — | — | 3 | 5 | 2 | 2 | — | — | 12 |
| Phase 1 | 23 | 3 | — | 10 | 186 | 27 | 4 | — | 10 | 263 |
| Phase 1/2 | 26 | 7 | — | 7 | 56 | 19 | 7 | 1 | 11 | 134 |
| Phase 2 | 45 | 16 | 1 | 36 | 315 | 90 | 17 | 3 | 124 | 647 |
| Phase 2/3 | 3 | 1 | — | 3 | 10 | — | — | — | 3 | 20 |
| Phase 3 | 45 | 16 | — | 19 | 68 | 13 | 1 | 1 | 25 | 188 |
| Phase 4 | — | 1 | — | — | 6 | — | — | 1 | 3 | 11 |
| Not applicable | 2 | 1 | — | — | 3 | 2 | 4 | — | 4 | 16 |
| Unknown | 1 | — | — | — | 5 | 1 | — | — | 6 | 13 |
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 | — | 56 | 40 | 217 | 6 | 76 | 6 | 8 | 6 | 415 |
| Colonic Neoplasms | 1 | 23 | 12 | 77 | 2 | 31 | 1 | 2 | 2 | 151 |
| Rectal Neoplasms | — | 20 | 11 | 84 | 3 | 28 | 1 | 3 | 1 | 151 |
| Pancreatic Neoplasms | 5 | 28 | 16 | 44 | 4 | 12 | — | 3 | 1 | 113 |
| Stomach Neoplasms | — | 22 | 10 | 56 | 3 | 12 | 3 | 1 | 4 | 111 |
| Neoplasm Metastasis | — | 25 | 7 | 41 | — | 16 | — | 1 | — | 90 |
| Neoplasms | — | 31 | 10 | 29 | — | 6 | — | — | — | 76 |
| Esophageal Neoplasms | — | 12 | 4 | 37 | — | 6 | — | 1 | 1 | 61 |
| Small Cell Lung Carcinoma | — | 9 | 9 | 19 | 1 | 7 | 1 | — | 1 | 47 |
| Lung Neoplasms | — | 13 | 3 | 27 | — | 1 | — | — | — | 44 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | National Cancer Institute (NCI) | 60 | 9 |
| 2 | Alliance for Clinical Trials in Oncology | 34 | 9 |
| 3 | Memorial Sloan Kettering Cancer Center | 33 | 0 |
| 4 | Fudan University | 29 | 5 |
| 5 | Sun Yat-sen University | 27 | 9 |
| 6 | M.D. Anderson Cancer Center | 20 | 0 |
| 7 | Children's Oncology Group | 19 | 6 |
| 8 | Pfizer | 18 | 7 |
| 9 | Eli Lilly and Company | 15 | 2 |
| 10 | Merck Sharp & Dohme LLC | 15 | 5 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Irinotecan | 1304 |
| 2 | Fluorouracil | 484 |
| 3 | Leucovorin | 422 |
| 4 | Oxaliplatin | 384 |
| 5 | Bevacizumab | 219 |
| 6 | Capecitabine | 153 |
| 7 | Cetuximab | 153 |
| 8 | Gemcitabine | 118 |
| 9 | Cisplatin | 113 |
| 10 | Temozolomide | 100 |
Evidence
- Results reported
- 40.8%267 of 654 completed
- Published
- 23.1%151 of 654 completed
- Primary endpoint met
- 36.8%32 of 87 analyses
- Median months to report
- 18
Documents disclosed
Trial profile
- Median enrollment
- 53
- Median duration
- 50.2months
- Countries
- 62
- Study sites
- 14334
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 12
- Phase 1
- 27
- Phase 1/2
- 49
- Phase 2
- 50
- Phase 2/3
- 375
- Phase 3
- 394
- Phase 4
- 128
- Not applicable
- 25
- Unknown
- 140
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | New York | United States | 166 |
| 2 | Los Angeles | United States | 148 |
| 3 | Chicago | United States | 133 |
| 4 | Boston | United States | 131 |
| 5 | Houston | United States | 123 |
| 6 | St Louis | United States | 113 |
| 7 | Philadelphia | United States | 112 |
| 8 | Seattle | United States | 112 |
| 9 | Nashville | United States | 101 |
| 10 | Ann Arbor | United States | 99 |
Terminations
- Terminated
- 154
- Withdrawn
- 35
- Suspended
- 6
- Stopped for recruitment
- 4.4%58 of 1304 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 |
|---|---|---|---|
| NCT06620302 Suspended | Suspended | Unacceptable Toxicity | 2031-12-30 |
| 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 |
| NCT04543916 Withdrawn | Withdrawn | AbbVie decided to stop trial involving Venetoclax for safety measures needed | 2028-06-30 |
| NCT05358704 Suspended | Suspended | no slots available | 2028-01-30 |
| NCT02366819 Suspended | Suspended | Pending data analysis | 2026-06-08 |
| NCT05238831 Withdrawn | Withdrawn | Withdrawn due to a change in therapeutic interventions. | 2026-05-31 |
| NCT05083481 Terminated | Terminated | Lack of clinical benefit | 2026-05-11 |
| NCT04481204 Withdrawn | Withdrawn | 0 participants | 2026-04-27 |
| NCT06509906 Terminated | Terminated | Sponsor Decision | 2025-12-02 |
| NCT06501989 Withdrawn | Withdrawn | Principal Investigator has left Inova | 2025-09-19 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: