Table 1.
Patient characteristics
| PF-04136309 BID + nab-P/Gem (N = 21)a | |||
|---|---|---|---|
| 750 mg n = 4 |
500 mg n = 17a |
Total n = 21 |
|
| Age, mean (range) | 61.3 (50–73) | 61.9 (46–79) | 61.8 (46–79) |
| Males / Females, n | 0 / 4 | 11 / 6 | 11 / 10 |
| Race, n (%) | |||
| White | 4 (100.0) | 15 (88.2) | 19 (90.5) |
| Black | 0 | 1 (5.9) | 1 (4.8) |
| Asian | 0 | 1 (5.9) | 1 (4.8) |
| ECOG PS | |||
| 0 | 3 (75.0) | 8 (47.1) | 11 (52.4) |
| 1 | 1 (25.0) | 8 (47.1) | 9 (42.9) |
| 2 | 0 | 1 (5.9) | 1 (4.8) |
| Site of metastatic disease, n (%) | |||
| Liver | 2 (50.0) | 14 (82.4) | 16 (76.2) |
| Lung | 1 (25.0) | 6 (35.3) | 7 (33.3) |
| Lymph node–Other | 1 (25.0) | 4 (23.5) | 5 (23.8) |
| Lymph node–Supraclavicular | 0 | 1 (5.9) | 1 (4.8) |
| Peritoneum | 0 | 2 (11.8) | 1 (4.8) |
| Other | 4 (100.0) | 14 (82.4) | 18 (85.7) |
| CA19.9 (U/mL) at baseline | |||
| n | 3 | 16 | 19 |
| Mean | 30197.33 | 15544.02 | 17857.70 |
| Range | 25.0–87160.0 | 0.5–112193.0 | 0.5–112193.0 |
| Assigned to treatment, n | |||
| Treated | 4 (100) | 17 (100) | 21 (100) |
| Discontinued | 4 (100) | 17 (100) | 21 (100) |
| DLT, n (%)b | 1 (25) | 3 (17.6) | 4 (19.0)c |
First subject–first visit: May 4, 2016; Last subject–first visit: September 15, 2017
aTwenty-two patients (n = 4 and 18 in the PF-04136309 750 mg BID + nab-paclitaxel/gemcitabine and PF-04136309 500 mg BID + nab-paclitaxel/gemcitabine groups, respectively) were assigned to study treatment, but one patient from the 500-mg BID group withdrew consent and did not receive study treatment
bDLT observation periods that occur in the first cycle of treatment (days 1 through 28) and are attributed (i.e., judged to be at least possibly related) to the combination of PF-04136309 plus nab-paclitaxel/gemcitabine where relationship with the combination cannot be ruled out. DLTs are classified according to CTCAE version 4.03. A patient is classified as DLT evaluable if he/she experiences a DLT or a DLT is absent but patient receives 85% of the planned doses of each study drug in the first 28-day cycle
c5 DLTs were reported in four patients
Abbreviations: CA-19.9 cancer antigen 19.9, CTCAE Common Terminology Criteria for Adverse Events, DLT dose-limiting toxicities, ECOG PS Eastern Cooperative Oncology Group performance status, nab-P/Gem nab-paclitaxel/gemcitabine