Drugs / Temozolomide
Temozolomide
DrugTemozolomide is marketed as Temodar, an alkylating antineoplastic drug used in adults with newly diagnosed glioblastoma (with radiotherapy then maintenance) and anaplastic astrocytoma settings. It is a prodrug that converts nonenzymatically to MTIC, which alkylates DNA and induces tumor cell death. U.S. initial approval was in 1999.
- Trials
- 928
- Recruiting
- 128
- Completed
- 421
- With results
- 252
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | 5 | — | — | 3 | 8 | 1 | 3 | — | 1 | 21 |
| Phase 1 | 19 | 3 | — | 18 | 110 | 32 | 5 | — | 11 | 198 |
| Phase 1/2 | 31 | 8 | — | 12 | 54 | 23 | 2 | 2 | 15 | 147 |
| Phase 2 | 50 | 18 | 1 | 39 | 203 | 46 | 11 | 1 | 63 | 432 |
| Phase 2/3 | 4 | 2 | — | 4 | 4 | 1 | 1 | — | 4 | 20 |
| Phase 3 | 15 | 3 | — | 7 | 28 | 10 | 2 | — | 13 | 78 |
| Phase 4 | — | 1 | — | — | 3 | — | — | — | — | 4 |
| Not applicable | 2 | — | — | — | 6 | 2 | 1 | — | 5 | 16 |
| Unknown | 2 | 1 | — | — | 5 | 2 | 1 | — | 1 | 12 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Glioblastoma | 7 | 106 | 71 | 158 | 8 | 40 | 2 | 5 | 9 | 406 |
| Brain Neoplasms | 3 | 38 | 26 | 72 | 1 | 17 | 1 | 2 | 1 | 161 |
| Glioma | 6 | 41 | 26 | 70 | 1 | 7 | 1 | 4 | 4 | 160 |
| Gliosarcoma | 1 | 48 | 23 | 46 | 2 | 8 | — | 2 | 1 | 131 |
| Astrocytoma | 1 | 38 | 12 | 37 | 3 | 16 | 1 | 2 | 4 | 114 |
| Central Nervous System Neoplasms | 1 | 30 | 14 | 50 | — | 9 | — | 5 | 1 | 110 |
| Melanoma | — | 14 | 17 | 37 | 1 | 7 | — | — | — | 76 |
| Oligodendroglioma | 1 | 27 | 4 | 29 | 1 | 8 | 1 | 2 | 1 | 74 |
| Neuroblastoma | 2 | 12 | 10 | 18 | — | 2 | — | — | — | 44 |
| Medulloblastoma | 1 | 15 | 6 | 10 | 1 | — | — | — | — | 33 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | National Cancer Institute (NCI) | 61 | 7 |
| 2 | M.D. Anderson Cancer Center | 30 | 0 |
| 3 | Duke University | 24 | 0 |
| 4 | Memorial Sloan Kettering Cancer Center | 24 | 0 |
| 5 | Merck Sharp & Dohme LLC | 22 | 2 |
| 6 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 19 | 0 |
| 7 | European Organisation for Research and Treatment of Cancer - EORTC | 17 | 6 |
| 8 | Mayo Clinic | 12 | 0 |
| 9 | University of California, San Francisco | 12 | 0 |
| 10 | Children's Oncology Group | 11 | 0 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Temozolomide | 928 |
| 2 | Radiotherapy | 192 |
| 3 | Irinotecan | 100 |
| 4 | Bevacizumab | 78 |
| 5 | Radiation | 63 |
| 6 | Carboplatin | 41 |
| 7 | Vincristine | 40 |
| 8 | Etoposide | 32 |
| 9 | Cyclophosphamide | 30 |
| 10 | Lomustine | 28 |
Evidence
- Results reported
- 59.9%252 of 421 completed
- Published
- 28.3%119 of 421 completed
- Primary endpoint met
- 32.9%26 of 79 analyses
- Median months to report
- 17
Documents disclosed
Trial profile
- Median enrollment
- 43
- Median duration
- 57.6months
- Countries
- 60
- Study sites
- 8016
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 15
- Phase 1
- 26
- Phase 1/2
- 52
- Phase 2
- 49
- Phase 2/3
- 155
- Phase 3
- 307
- Phase 4
- 65
- Not applicable
- 20
- Unknown
- 82
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | New York | United States | 154 |
| 2 | Houston | United States | 142 |
| 3 | Boston | United States | 132 |
| 4 | Chicago | United States | 115 |
| 5 | Philadelphia | United States | 115 |
| 6 | Los Angeles | United States | 101 |
| 7 | San Francisco | United States | 95 |
| 8 | Cleveland | United States | 89 |
| 9 | Durham | United States | 87 |
| 10 | St Louis | United States | 85 |
Terminations
- Terminated
- 117
- Withdrawn
- 26
- Suspended
- 3
- Stopped for recruitment
- 5.4%50 of 928 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 |
|---|---|---|---|
| NCT06639607 Suspended | Suspended | Drugs/Equipment Unavailable | 2051-06-30 |
| NCT04105374 Withdrawn | Withdrawn | NCI approval withdrawn | 2030-11-30 |
| NCT06202066 Suspended | Suspended | pending protocol changes | 2028-10-15 |
| NCT04890093 Suspended | Suspended | Pending updated agreements in order to enroll additional participants. | 2027-12-31 |
| NCT04796454 Withdrawn | Withdrawn | Company decision | 2026-08-31 |
| NCT04019327 Terminated | Terminated | Study terminated by sponsor | 2025-12-04 |
| NCT04239092 Terminated | Terminated | The decision to conclude study was made to optimize the clinical study design and protocol to further evaluate the safety profile of elraglusib (9-ING-41) in pediatric and adult patients with refractory Ewings Sarcoma. | 2025-07-07 |
| NCT05429502 Terminated | Terminated | Study halted early due to high toxicity risk (from BHLRM model) in combo treatment and inability to identify recommended Phase 2 dose in initial phase (Phase 1-Part A), making continuation to subsequent phases (Phase 1-Part B and Phase 2) unfeasible. | 2025-02-26 |
| NCT01430351 Terminated | Terminated | \<75 % participant accrual | 2025-02-02 |
| NCT04525014 Terminated | Terminated | Low Enrollment | 2024-07-29 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: