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Dose Escalation Scheme and Dose-Limiting Toxicity.
| Lurbinectedin Dose | Number of Evaluable Patients/Number of Treated Patients | Number of Patients with DLTs | DLT |
|---|---|---|---|
| 3.5 mg D1,8 | 3/3 | 0 | --- |
| 5.0 mg D1,8 | 3/4 | 0 | --- |
| 7.0 mg D1,8 | 7/11 | 2 (18.2%) | Hyperbilirubinemia (grade 3, n=1) Oral herpes (grade 3, n=1) |
| 6.0 mg D1,8 | 3/6 | 1 (16.7%) | Rhabdomyolysis (grade 4, n=1) |
| 2.0 mg D1–3 | 4/5 | 0 | --- |
| 3.0 mg D1–3 | 2/6 | 0 | --- |
| 1.0 mg D1–3 | 3/4 | 0 | --- |
| 1.5 mg D1–3 | 2/3 | 0 | --- |
Data shown are n (%) of patients.
