Table 2.
Dose‐limiting toxicities observed in part 1 of a two‐part phase I trial of palbociclib
| Tumor type | Disease stage at time of study entry | Sex | Age, years | Duration from histopathologic diagnosis, years | DLT |
|---|---|---|---|---|---|
| 100‐mg dose group | |||||
| Ovarian cancer | III C | Female | 62 | 3.49 | None |
| Breast cancer | IV | Female | 65 | 10.28 | Yes† |
| Colon cancer | IV | Female | 49 | 1.46 | None |
| Medullary thyroid cancer | IV | Male | 44 | 3.05 | None |
| Rectal cancer | IV | Female | 56 | 2.46 | None |
| Breast cancer | IV | Female | 65 | 2.36 | None |
| 125‐mg dose group | |||||
| Inflammatory myofibroblastic tumor | IV B | Male | 24 | 1.86 | None |
| Pancreatic acinar cell carcinoma | IV | Female | 24 | 0.52 | None |
| Esophageal cancer | IV | Male | 42 | 2.27 | None |
| Fibroma | IV | Male | 58 | 3.00 | None |
| Breast cancer | IV | Female | 69 | 12.08 | Yes‡ |
| Rectal cancer | IV | Male | 55 | 2.01 | None |
†Less than 75% of planned dose received because of decreased neutrophil count (grades 3 and 4). ‡Decreased platelet count (grade 4). DLT, dose‐limiting toxicity.