Table 1.
Patient Information for the modified intent-to-treat (mITT) population (N = 89).
| Diagnosis | # (%) |
|---|---|
| AA (WHO Grade III) | 27 (30.3) |
| GBM (WHO Grade IV) | 62 (69.7) |
| Gender | # (%) |
| Female | 25 (28.1) |
| Male | 64 (71.9) |
| Race | # (%) |
| Caucasian | 58 (65.2) |
| Asian | 31 (34.8) |
| Black | 0 (0.0) |
| Age (Years) | |
| Median (Range) | 45 (19–73) |
| Mean ± SE | 46.3 ± 1.3 |
| KPS Score at Baseline | |
| Median (Range) | 90 (70–100) |
| Mean ± SE | 88 ± 1 |
| Size of Largest Target Tumor Lesion | |
| 2-D in cm2 – Median (Mean ± SE) | 8.6 (9.3 ± 0.5) |
| 3-D in cm3 – Median (Mean ± SE) | 21.5 (27.2 ± 2.5) |
| OT101 Dose Cohort | # (%) |
| Low (2.5 mg/cycle) | 40 (44.9) |
| High (19.8 mg/cycle) | 49 (55.1) |
| Number of OT101 Cycles | |
| Median (Range) | 6 (1–11) |
| Mean ± SE | 7.0 ± 0.3 |
| Total OT101 Dose (mg/m2) | |
| Median (Range) | 22.7 (1.1–152.1) |
| Mean ± SE | 45.2 ± 4.6 |
| Time from last cancer therapy | |
| Median (Mean ± SE) | 103 (248 ± 53) |
| Time from Diagnosis | |
| Median (Mean ± SE) | 229 (379 ± 59) |
| Previous antitumor therapy | # (%) |
| Surgery | 89 (100) |
| Radiotherapy | 81 (91.0) |
| Chemotherapy | 48 (53.9) |
| Other | 13 (14.6) |
| Number of previous surgeries | # (%) |
| 1 | 64 (71.9) |
| 2 | 19 (21.3) |
| > 2 | 6 (6.7) |
| Number of previous radiotherapies | # (%) |
| 0 | 8 (9.0) |
| 1 | 73 (82.0) |
| 2 | 8 (9.0) |
| Number of previous chemotherapies | |
| 0 | 41 (46.1) |
| 1 | 48 (53.9) |
| Number of previous other therapies | # (%) |
| 0 | 76 (85.3) |
| 1 | 11 (12.4) |
| 2 | 2 (2.2) |
| Number of measurable enhancing lesions* | # (%) |
| 1 | 68 (78.2) |
| 2 | 14 (16.1) |
| 3 | 5 (5.7) |
| Number of NMEL* | # (%) |
| 0 | 67 (77.0) |
| 1 | 12 (13.8) |
| 2 | 5 (5.7) |
| 3 | 3 (3.4) |
* Central MRI review data were not available in two patients. NMEL: non-measurable enhancing lesions.