TABLE I.

Phase i clinical trials with temsirolimus ⁵

Reference	Tumour type	Pts (n)	Daily dose (mg)	Regimen	Daily mtd (mg)	Toxicity	Activity
Hidalgo et al., 200025	Renal cell carcinoma, nsclc, soft-tissue sarcomas, cervical and uterine carcinomas	51	0.75–19.1/m2	Intravenous days 1–5 every 2 weeks	—a	Hypocalcemia, skin rash, stomatitis, thrombocytopenia	pr: 2% mr or sd: 15%
Farouzesh et al., 200226	Renal cell carcinoma, nsclc, myxoid chondrosarcoma, mesothelioma, leyomiosarcoma	24	25–75	Oral, days 1–5 every 2 weeks	100	Stomatitis, rash, hypertransaminemia	sd: 33%
Punt et al., 200327	Colorectal, gastric carcinoma, esophageal, head-and-neck cancer	28	15–75/m2	Temsirolimus in combination with 5-fu/lv	—	Stomatitis/mucositis	pr : 11%
Raymond et al., 200421	Renal cell carcinoma, soft-tissue sarcoma, mesothelioma, nsclc, breast, head-and-neck, melanoma, pancreatic, prostate, neuroendocrine, adrenocortical carcinoma	24	7.5–220/m2	Intravenous weekly	—	Skin rash, stomatitis, thrombocytopenia, bipolar disorder	pr : 8.3% mr: 8%
Chang et al., 200428	Glioblastoma	12	250–300	Temsirolimus in combination with enzyme-inducing anti-epileptic drugs, weekly	250	Stomatitis, hypertriglyceridemia

^a 15 mg/m² in heavily pretreated patients.

Pts = patients; mtd = maximal tolerated dose; nsclc = non-small-cell lung cancer; pr = partial response; mr = minor response; sd = stable disease; 5-fu = 5-fluorouracil; lv =leucovorin.