DLT and response in the dose-finding cohorts
| Cohort . | Pralatrexate dose, mg/m2/wk, schedule . | n . | Patients with DLTs,* N (toxicity, grade) . | Response rate, % (n/N) . | Response type . |
|---|---|---|---|---|---|
| 1 | 30, 3/4 wks | 2 | 2 (anorexia, grade 2; weakness, grade 3) | 100 (2/2) | 2 PR |
| 2 | 20, 3/4 wks | 3 | 2 (stomatitis, grade 2) | 67 (2/3) | 2 PR |
| 3 | 20, 2/3 wks | 7 | 3 (stomatitis, grade 2-3; elevated liver function tests, grade 3) | 57 (4/7) | 1 CR/3 PR |
| 4 | 15, 3/4 wks | 6 | 3 (stomatitis, grade 2; fatigue, grade 2) | 50 (3/6) | 3 PR |
| 5 | 15, 2/3 wks | 3 | 2 (stomatitis, grade 2; dehydration, grade 2) | 0 (0/3) | — |
| 6 | 10, 3/4 wks | 10 | 3 (thrombocytopenia/neutropenia, grade 3; skin lesion, grade 3; zoster, grade 3) | 10 (1/10) | 1 CR |
| Cohort . | Pralatrexate dose, mg/m2/wk, schedule . | n . | Patients with DLTs,* N (toxicity, grade) . | Response rate, % (n/N) . | Response type . |
|---|---|---|---|---|---|
| 1 | 30, 3/4 wks | 2 | 2 (anorexia, grade 2; weakness, grade 3) | 100 (2/2) | 2 PR |
| 2 | 20, 3/4 wks | 3 | 2 (stomatitis, grade 2) | 67 (2/3) | 2 PR |
| 3 | 20, 2/3 wks | 7 | 3 (stomatitis, grade 2-3; elevated liver function tests, grade 3) | 57 (4/7) | 1 CR/3 PR |
| 4 | 15, 3/4 wks | 6 | 3 (stomatitis, grade 2; fatigue, grade 2) | 50 (3/6) | 3 PR |
| 5 | 15, 2/3 wks | 3 | 2 (stomatitis, grade 2; dehydration, grade 2) | 0 (0/3) | — |
| 6 | 10, 3/4 wks | 10 | 3 (thrombocytopenia/neutropenia, grade 3; skin lesion, grade 3; zoster, grade 3) | 10 (1/10) | 1 CR |
2/3 indicates 2 of 3 weeks; 3/4, 3 of 4 weeks; DLT, dose limiting toxicity; CR, complete response; PR, partial response; and —, no response noted.
Some patients experienced more than 1 DLT.