Summary of Phase I vorinostat trials
| Trial . | N . | Population . | Maximum tolerated dose . | Activity . |
|---|---|---|---|---|
| Kelly et al16 | 73 | Advanced solid and hematologic malignancies | 400 mg orally 4 times a day or 200 mg orally twice a day for continuous daily dosing; 300 mg orally twice a day for 3 consecutive days per week dosing | CR: DLBCL; PR: CTCL,* mesothelioma, laryngeal and thyroid cancer; prolonged SD: renal cell and thyroid cancer |
| Richardson et al18 | 13 | Advanced multiple myeloma | Not determined† | Of 10 evaluable patients: 1 MR, 9 SD |
| Rubin et al19 | 23 | Advanced solid tumors | Not determined‡ | PR: ovarian cancer, prolonged; SD: breast and non–small cell lung cancer |
| Kelly et al37 | 37 | Advanced solid and hematologic malignancies | 300 mg/m2 per day intravenously by 5 days for 3 weeks followed by a 1-week rest§ | PR: Hodgkin disease*; MR: bladder cancer; SD: Hodgkin disease |
| Trial . | N . | Population . | Maximum tolerated dose . | Activity . |
|---|---|---|---|---|
| Kelly et al16 | 73 | Advanced solid and hematologic malignancies | 400 mg orally 4 times a day or 200 mg orally twice a day for continuous daily dosing; 300 mg orally twice a day for 3 consecutive days per week dosing | CR: DLBCL; PR: CTCL,* mesothelioma, laryngeal and thyroid cancer; prolonged SD: renal cell and thyroid cancer |
| Richardson et al18 | 13 | Advanced multiple myeloma | Not determined† | Of 10 evaluable patients: 1 MR, 9 SD |
| Rubin et al19 | 23 | Advanced solid tumors | Not determined‡ | PR: ovarian cancer, prolonged; SD: breast and non–small cell lung cancer |
| Kelly et al37 | 37 | Advanced solid and hematologic malignancies | 300 mg/m2 per day intravenously by 5 days for 3 weeks followed by a 1-week rest§ | PR: Hodgkin disease*; MR: bladder cancer; SD: Hodgkin disease |
CR indicates complete response; CTCL, cutaneous T-cell lymphoma; DLBCL, diffuse large B-cell lymphoma; MR, minor response; PR, partial response; SD, stable disease.
*O'Connor et al.17
†The maximum administered doses were 250 mg orally twice a day for 5 days/week (4-week cycle) and 200 mg orally twice a day for 14 days (3-week cycle).
‡400 mg orally on days 1, 5, and 7 to 28 was evaluated.
§For patients with hematologic malignancies; not determined for patients with solid tumors.