| Gemcitabine + Erlotinib (100 mg QD) | Motesanib + Gemcitabine + Erlotinib (100 mg QD) | Motesanib + Erlotinib (150 mg QD) | ||||
---|---|---|---|---|---|---|---|
Characteristic | Control (n = 8) | Motesanib 50 mg QD (n = 7) | Motesanib 100 mg QD (n = 8) | Motesanib 125 mg QD (n = 10) | Motesanib 75 mg BID (n = 9) | Motesanib 100 mg QD (n = 7) | Motesanib 125 mg QD (n = 7) |
Sex, n | Â | Â | Â | Â | Â | Â | Â |
   Women | 3 | 6 | 3 | 5 | 7 | 7 | 2 |
   Men | 5 | 1 | 5 | 5 | 2 | 0 | 5 |
Race, n | Â | Â | Â | Â | Â | Â | Â |
   White | 7 | 7 | 6 | 10 | 6 | 6 | 7 |
   Asian | 0 | 0 | 2 | 0 | 3 | 1 | 0 |
   Japanese | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Median age, y (range) | 62 (36-71) | 66 (46-80) | 50 (40-75) | 59.5 (36-77) | 53 (21-76) | 50 (35-76) | 55 (46-73) |
ECOG performance status, n | Â | Â | Â | Â | Â | Â | Â |
   0 | 3 | 1 | 5 | 4 | 4 | 5 | 5 |
   1 | 5 | 5 | 3 | 5 | 5 | 2 | 2 |
   2 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
Disease stage, n | Â | Â | Â | Â | Â | Â | Â |
   I | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
   II | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
   III | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
   IV | 8 | 7 | 7 | 8 | 8 | 7 | 6 |
Tumor type, n | Â | Â | Â | Â | Â | Â | Â |
   Colon | 3 | 0 | 1 | 1 | 1 | 1 | 0 |
   Pancreatic | 1 | 1 | 0 | 1 | 0 | 0 | 2 |
   Breast | 0 | 0 | 1 | 0 | 0 | 2 | 1 |
   Melanoma | 0 | 0 | 1 | 1 | 1 | 0 | 0 |
   Non—small |  |  |  |  |  |  |  |
cell lung | 0 | 1 | 1 | 0 | 1 | 0 | 0 |
   Squamous cell |  |  |  |  |  |  |  |
head/neck | 0 | 1 | 1 | 0 | 0 | 1 | 0 |
   Medullary |  |  |  |  |  |  |  |
thyroid | 0 | 0 | 1 | 1 | 0 | 0 | 1 |
   Carcinoma |  |  |  |  |  |  |  |
unknown | Â | Â | Â | Â | Â | Â | Â |
origin | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
   Ovarian | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
   Prostate | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
   Stomach | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
   Othera | 3 | 2 | 2 | 5 | 4 | 3 | 1 |
Prior therapy, nb | Â | Â | Â | Â | Â | Â | Â |
   0 | 3 | 1 | 0 | 6 | 2 | 1 | 1 |
   1 to 2 | 1 | 2 | 3 | 1 | 4 | 1 | 1 |
   3 to 4 | 1 | 2 | 2 | 1 | 0 | 1 | 3 |
   ≥ 5 | 3 | 2 | 3 | 2 | 3 | 4 | 2 |
Prior chemotherapy, n | Â | Â | Â | Â | Â | Â | Â |
   0 | 3 | 2 | 2 | 8 | 2 | 1 | 1 |
   1 to 2 | 1 | 3 | 3 | 1 | 4 | 2 | 3 |
   3 to 4 | 1 | 1 | 2 | 1 | 1 | 1 | 1 |
   ≥ 5 | 3 | 1 | 1 | 0 | 2 | 3 | 2 |
Prior radiotherapy, n | Â | Â | Â | Â | Â | Â | Â |
   0 | 5 | 3 | 3 | 6 | 5 | 5 | 4 |
   1 to 2 | 3 | 3 | 3 | 3 | 3 | 1 | 2 |
   3 to 4 | 0 | 1 | 2 | 0 | 1 | 1 | 1 |
   ≥ 5 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |