Table 5.
Dose‐Finding Studies Postmarketing (Oncology)
| Drug | Disease (Registered Dose) | Studied Doses Postmarketing | References |
|---|---|---|---|
| Glivec | GIST (400 mg/d) | None | |
| Lysodren | Adrenal cortex neoplasms (2–3 g/d) | Low‐dose regimen (1–3 g/d) vs high‐dose regimen (1.5–6 g/d) | Kerkhofs et al, 201324 |
| Glivec | DFSP (800 mg/day) | None | |
| Nexavar | RCC (400 mg BID) | 400 mg BID, escalated to 600 and 800 mg BID | Gore et al, 201725 |
| Sutent | GIST (50 mg QD on schedule 4/2) | Morning or evening dosing 37.5 mg/d | George et al, 200926 |
| Sutent | RCC (50 mg QD on schedule 4/2) | The same daily dose 5 consecutive days per week for 5 weeks and then the same daily dose on days 1, 3, and 5 in the sixth week; consecutive 6‐week cycles | Buti et al, 201727 |
| Nexavar | HCC (400 mg BID) | 600 mg BID in patients with radiologic disease progression | Rimassa et al, 201328 |
| Torisel | RCC (25 mg QW) | 20 mg/m2 QW for tolerability assessment; the remaining received 25 mg QW (East Asian patients) | Sun et al, 201229 |
| Yondelis | STS (1.5 mg/m2 Q3W) | None | n/a |
| Afinitor | RCC (10 mg OD) | None | n/a |
| Mepact | Osteosarcoma (2 mg/m2 Q2W for 12 weeks, followed by QW for 24 weeks for a total of 48 infusions in 36 weeks) | None | n/a |
| Yondelis | Ovarian cancer (1.1 mg/m2 Q3W) | None | n/a |
| Cometriq | Thyroid cancer (140 mg OD) | None | n/a |
| Cyramza | Gastric cancer (8 mg/kg Q2W) | None | n/a |
| Lynparza | Ovarian cancer (400 mg BID) | 300 mg BID | Pujade‐Lauraine et al, 201730 |
| 200–450 mg BID | Mateo et al, 201631 | ||
| Nexavar | Thyroid cancer (400 mg BID) | 200 mg BID (Chinese patients) | Chen et al, 201132 |
| Lenvima | Thyroid cancer (24 mg QD) | None | n/a |
| Unituxin | Neuroblastoma (17.5 mg/[m2·d] on days 4–7 [courses 1, 3, and 5] and on days 8–11 [courses 2 and 4]) | None | n/a |
| Lartruvo | Sarcoma (15 mg/kg on days 1 and 8 of each 3‐wk cycle) | None | n/a |
| Onivyde | Pancreatic cancer (80 mg/m2 Q2W) | None | n/a |
| Isqette | Neuroblastoma (5 daily infusions of 20 mg/m2 or continuous 10 mg/m2 infusion) | None | n/a |
BID indicates twice daily; DFSP, dermatofibrosarcoma protuberans; GIST, gastrointestinal stromal tumor; HCC, hepatocellular carcinoma; n/a, not applicable; OD, once daily; QD, once daily; QW, every week; Q2W, every 2 weeks; Q3W, every 3 weeks; RCC, renal cell carcinoma; STS, soft tissue sarcoma.