Table 1.
Patient Demographics and Baseline Characteristics
| Demographic or Characteristic | Phase I |
Phase II (ITT population) |
||||||
|---|---|---|---|---|---|---|---|---|
| ABT-751 200 mg + Pemetrexed(n = 3) |
ABT-751 250 mg + Pemetrexed(n = 6) |
ABT-751 200 mg + Pemetrexed(n = 83) |
Placebo + Pemetrexed(n = 82) |
|||||
| No. | % | No. | % | No. | % | No. | % | |
| Sex | ||||||||
| Male | 1 | 33.3 | 2 | 33.3 | 58 | 69.9 | 54 | 65.9 |
| Female | 2 | 66.7 | 4 | 66.7 | 25 | 30.1 | 28 | 34.1 |
| Race | ||||||||
| White | 3 | 100.0 | 4 | 66.7 | 81 | 97.6 | 73 | 89.0 |
| Black | 0 | 2 | 33.3 | 2 | 2.4 | 7 | 8.5 | |
| Asian | 0 | 0 | 0 | 2 | 2.4 | |||
| Ethnicity | ||||||||
| Hispanic | 0 | 0 | 1 | 1.2 | 1 | 1.2 | ||
| Non-Hispanic | 3 | 100.0 | 6 | 100.0 | 82 | 98.8 | 81 | 98.8 |
| Age, years | ||||||||
| Median | 60 | 59.5 | 64 | 60.5 | ||||
| Range | 58-62 | 50-73 | 31-83 | 42-87 | ||||
| Smoking history | ||||||||
| Current or former | 3 | 100.0 | 6 | 100.0 | 72 | 86.7 | 71 | 86.6 |
| Never-smoker | 0 | 0 | 11 | 13.3 | 11 | 13.4 | ||
| Performance status | ||||||||
| 0-1 | 3 | 100.0 | 6 | 100.0 | 76 | 1.6 | 72 | 87.8 |
| ≥ 2 | 0 | 0 | 7 | 8.4 | 10 | 12.2 | ||
| Prior antitumor regimens* | ||||||||
| 1 | 2 | 66.7 | 5 | 83.3 | 75 | 90.4 | 68 | 82.9 |
| 2 | 1 | 33.3 | 1 | 16.7 | 8 | 9.6 | 14 | 17.1 |
| Time since last anti-tumor treatment, months | ||||||||
| < 3 | 1 | 33.3 | 3 | 50.0 | 42 | 50.6 | 43 | 52.4 |
| ≥ 3 | 2 | 66.7 | 3 | 50.0 | 41 | 49.4 | 39 | 47.6 |
| Disease stage | ||||||||
| 3 | 0 | 2 | 33.3 | 21 | 25.3 | 14 | 17.1 | |
| 4 | 3 | 100.0 | 4 | 66.7 | 62 | 74.7 | 67 | 81.7 |
| Unknown | 0 | 0 | 0 | 1 | 1.2 | |||
| Histology | ||||||||
| Squamous cell | 1 | 33.3 | 2 | 33.3 | 25 | 30.1 | 20 | 24.4 |
| Nonsquamous | 2 | 66.7 | 4 | 66.7 | 58 | 69.9 | 62 | 75.6 |
Abbreviation: ITT, intention to treat.
*
Only one prior chemotherapy regimen was allowed as per eligibility criteria, but prior adjuvant therapy was permitted.