Drugs / Vinorelbine
Vinorelbine
DrugVinorelbine is marketed as Navelbine, a vinca alkaloid antineoplastic agent indicated for first-line treatment of locally advanced or metastatic non-small cell lung cancer, either with cisplatin or as single-agent therapy. U.S. initial approval was in 1994.
- Trials
- 448
- Recruiting
- 31
- Completed
- 218
- With results
- 88
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | Active | Completed | Terminated | Withdrawn | Unknown | No longer available | Total |
|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | — | — | — | 1 | — | 1 | — | — | 2 |
| Phase 1 | — | — | 1 | 29 | 5 | 1 | 6 | — | 42 |
| Phase 1/2 | 3 | — | 1 | 13 | 6 | — | 1 | — | 24 |
| Phase 2 | 13 | 5 | 6 | 119 | 30 | 6 | 57 | — | 236 |
| Phase 2/3 | — | — | — | 1 | 3 | — | 1 | — | 5 |
| Phase 3 | 13 | 4 | 14 | 45 | 8 | 5 | 22 | — | 111 |
| Phase 4 | — | — | — | 5 | 1 | — | 2 | — | 8 |
| Not applicable | 1 | — | 1 | 3 | — | — | 3 | — | 8 |
| Unknown | 1 | — | 1 | 2 | 2 | — | 5 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Breast Neoplasms | 2 | 15 | 11 | 92 | 4 | 34 | 3 | 2 | 5 | 168 |
| Carcinoma, Non-Small-Cell Lung | — | 14 | 3 | 53 | 1 | 35 | 2 | 1 | 2 | 111 |
| Lung Neoplasms | — | 5 | 3 | 22 | 1 | 20 | 1 | 2 | — | 54 |
| Hodgkin Disease | — | 1 | 3 | 15 | — | 3 | — | — | — | 22 |
| Neoplasm Metastasis | — | — | 2 | 9 | — | 5 | — | — | 1 | 17 |
| Recurrence | — | — | 2 | 12 | — | 2 | — | — | — | 16 |
| Lymphoma | — | 2 | 2 | 10 | — | 1 | — | — | — | 15 |
| Neoplasms | — | 3 | 2 | 6 | — | 3 | — | — | — | 14 |
| Triple Negative Breast Neoplasms | — | 1 | — | 6 | — | 6 | — | — | 1 | 14 |
| Adenocarcinoma of Lung | — | 1 | — | 4 | — | 5 | — | — | — | 10 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Fudan University | 12 | 1 |
| 2 | Sun Yat-sen University | 11 | 5 |
| 3 | National Cancer Institute (NCI) | 10 | 5 |
| 4 | Hellenic Oncology Research Group | 9 | 3 |
| 5 | Children's Oncology Group | 7 | 4 |
| 6 | Dana-Farber Cancer Institute | 7 | 1 |
| 7 | Hoffmann-La Roche | 7 | 3 |
| 8 | Memorial Sloan Kettering Cancer Center | 7 | 0 |
| 9 | University of Washington | 7 | 0 |
| 10 | Alliance for Clinical Trials in Oncology | 6 | 2 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Vinorelbine | 448 |
| 2 | Gemcitabine | 143 |
| 3 | Cisplatin | 92 |
| 4 | Capecitabine | 87 |
| 5 | Docetaxel | 68 |
| 6 | Paclitaxel | 63 |
| 7 | Carboplatin | 60 |
| 8 | Trastuzumab | 55 |
| 9 | eribulin | 40 |
| 10 | Pemetrexed | 39 |
Evidence
- Results reported
- 40.4%88 of 218 completed
- Published
- 26.1%57 of 218 completed
- Primary endpoint met
- 48.6%17 of 35 analyses
- Median months to report
- 18
Documents disclosed
Trial profile
- Median enrollment
- 78
- Median duration
- 55.6months
- Countries
- 74
- Study sites
- 7305
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 30
- Phase 1
- 23
- Phase 1/2
- 47
- Phase 2
- 59
- Phase 2/3
- 113
- Phase 3
- 341
- Phase 4
- 87
- Not applicable
- 44
- Unknown
- 100
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | New York | United States | 45 |
| 2 | Chicago | United States | 44 |
| 3 | Barcelona | Spain | 39 |
| 4 | Boston | United States | 39 |
| 5 | Los Angeles | United States | 39 |
| 6 | Paris | France | 38 |
| 7 | Madrid | Spain | 36 |
| 8 | Shanghai | China | 36 |
| 9 | Beijing | China | 35 |
| 10 | Milan | Italy | 35 |
Terminations
- Terminated
- 55
- Withdrawn
- 13
- Stopped for recruitment
- 4.5%20 of 448 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 |
|---|---|---|---|
| NCT05711628 Withdrawn | Withdrawn | Other - Protocol moved to Withdrawn | 2028-06-30 |
| NCT05238831 Withdrawn | Withdrawn | Withdrawn due to a change in therapeutic interventions. | 2026-05-31 |
| NCT05583110 Terminated | Terminated | The study was closed early due to safety concerns and an unfavorable benefit-risk balance. Unexpected high neutropenia rates required a costly sub-study, which was not feasible, forcing the sponsor to terminate the trial prematurely. | 2025-05-30 |
| NCT04765709 Terminated | Terminated | Low enrolment rate | 2025-01-30 |
| NCT06137651 Withdrawn | Withdrawn | Study terminated by the sponsor | 2024-03-27 |
| NCT05583188 Terminated | Terminated | Strategic | 2024-03-18 |
| NCT03770299 Withdrawn | Withdrawn | Business objectives have changed | 2024-03-14 |
| NCT02974426 Terminated | Terminated | Enrollment was delayed and the number of eligible patients significantly declined with the use of neoadjuvant or adjuvant ICIs and TKIs therapies. Thus, this trial was closed due to insufficient accrual. | 2024-02-29 |
| NCT03393741 Terminated | Terminated | slow accrual | 2024-02-11 |
| NCT04265274 Withdrawn | Withdrawn | Poor acrual | 2023-01-01 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: