Table 1.

Patient characteristics

Number of patients
Q3WQ1W
Screened3028
Assessable for toxicity; safety population2827
Assessable for PK; PK population2827
Assessable for response; efficacy population2527
Median age, years (range)62 (29–82)65 (38–78)
Gender: male/female16/1215/12
ECOG Performance status
 0 - Fully active79
 1 - Restricted2118
Primary cancer diagnosis, n (%)a
 NSCLC6 (21%)3 (11%)
 Head and neck2 (7%)
 Ovarian2 (7%)1 (4%)
 Prostate2 (7%)
 Rectal2 (7%)
 Anal1 (4%)
 Cervical1 (4%)
 Hepatocellular1 (4%)
 Kidney1 (4%)1 (4%)
 Pancreatic1 (4%)4 (15%)
 SCLC1 (4%)
 Bladder1 (4%)
 Breast1 (4%)
 Gastric1 (4%)
 Melanoma1 (4%)
 Uterine2 (7%)
 Otherb8 (29%)12 (44%)
Prior radiation therapy, n (%)a16 (57%)12 (44%)
Prior systemic chemotherapy/biologic therapy, n (%)a27 (96%)27 (100%)
Prior taxanes, n (%)a8 (29%)c15 (56%)d
 Prior docetaxel4 (14%)4 (15%)
 Prior paclitaxel4 (14%)7 (26%)
 Prior nab-paclitaxel1 (4%)5 (19%)
  • Abbreviations: PK, pharmacokinetics; SCLC, small cell lung cancer.

  • aPercentages are based on the safety population, Q3W (N = 28) and Q1W (N = 27).

  • bOther included one each of tonsillar, intrahepatic cholangiocarcinoma, ampullary, gastroesophageal, esophageal, gallbladder, eccrine, and adrenal for Q3W and one each of vulvar, ampullary, appendiceal carcinoma, urothelial carcinoma, renal, gastroesophageal, adenocarcinoma of unknown primary, and neuroendocrine, with two patients each with mesothelioma and cholangiocarcinoma for Q1W.

  • cOne patient received both prior paclitaxel and nab-paclitaxel.

  • dOne patient received both prior paclitaxel and docetaxel.