Table 2.
Hematologic and Non-hematologic Toxicities That Occurred in ≥ 10% of the Study Population
| Phase I (n=28) | Phase II (n=37) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| All | Grade 1 | Grade 2 | Grade 3 | Grade 4 | All | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| MedDRA Toxicity | No. (%) | No. (%) | No. (%) | No. (%) | No. (%) | No. (%) | No. (%) | No. (%) | No. (%) | No. (%) |
| Abdominal pain | 4 (14%) | 4 (14%) | 0 (0%) | 0 (0%) | 0 (0%) | 4 (11%) | 0 (0%) | 4 (11%) | 0 (0%) | 0 (0%) |
| Anemia | 5 (18%) | 0 (0%) | 0 (0%) | 5 (18%) | 0 (0%) | 2 (5%) | 0 (0%) | 2 (5%) | 0 (0%) | 0 (0%) |
| Anxiety | 3 (11%) | 2 (7%) | 1 (4%) | 0 (0%) | 0 (0%) | 1 (3%) | 1 (3%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Back pain | 3 (11%) | 3 (11%) | 0 (0%) | 0 (0%) | 0 (0%) | 2 (5%) | 0 (0%) | 2 (5%) | 0 (0%) | 0 (0%) |
| Chills | 6 (21%) | 6 (21%) | 0 (0%) | 0 (0%) | 0 (0%) | 3 (8%) | 3 (8%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Constipation | 7 (25%) | 4 (14%) | 3 (11%) | 0 (0%) | 0 (0%) | 7 (19%) | 6 (16%) | 1 (3%) | 0 (0%) | 0 (0%) |
| Cough | 8 (29%) | 4 (14%) | 4 (14%) | 0 (0%) | 0 (0%) | 6 (16%) | 6 (16%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Diarrhea | 8 (29%) | 6 (21%) | 2 (7%) | 0 (0%) | 0 (0%) | 14 (38%) | 10 (27%) | 4 (11%) | 0 (0%) | 0 (0%) |
| Dysguesia | 5 (18%) | 5 (18%) | 0 (0%) | 0 (0%) | 0 (0%) | 4 (11%) | 4 (11%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Dyspepsia | 4 (14%) | 4 (14%) | 0 (0%) | 0 (0%) | 0 (0%) | 4 (11%) | 4 (11%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Dyspnea | 10 (36%) | 5 (18%) | 5 (18%) | 0 (0%) | 0 (0%) | 8 (22%) | 8 (22%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Fatigue | 15 (54%) | 5 (18%) | 10 (36%) | 0 (0%) | 0 (0%) | 25 (68%) | 10 (27%) | 15 (41%) | 0 (0%) | 0 (0%) |
| Fever | 7 (25%) | 5 (18%) | 2 (7%) | 0 (0%) | 0 (0%) | 15 (41%) | 5 (14%) | 10 (27%) | 0 (0%) | 0 (0%) |
| Headache | 4 (14%) | 4 (14%) | 0 (0%) | 0 (0%) | 0 (0%) | 7 (19%) | 7 (19%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Hot flashes | 3 (11%) | 3 (11%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Hyperhidrosis | 3 (11%) | 3 (11%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Infusion-related reaction | 3 (11%) | 1 (4%) | 0 (0%) | 2 (7%) | 0 (0%) | 4 (11%) | 0 (0%) | 4 (11%) | 0 (0%) | 0 (0%) |
| Lung infection | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 5 (14%) | 0 (0%) | 0 (0%) | 5 (14%) | 0 (0%) |
| Myalagia | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 2 (5%) | 2 (5%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Nasal congestion | 3 (11%) | 3 (11%) | 0 (0%) | 0 (0%) | 0 (0%) | 2 (5%) | 2 (5%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Nausea | 15 (54%) | 5 (18%) | 10 (36%) | 0 (0%) | 0 (0%) | 25 (68%) | 20 (54%) | 5 (14%) | 0 (0%) | 0 (0%) |
| Neutrophil count decreased | 3 (11%) | 0 (0%) | 0 (0%) | 3 (11%) | 0 (0%) | 13 (35%) | 0 (0%) | 0 (0%) | 10 (27%) | 3 (8%) |
| Pain | 6 (21%) | 6 (21%) | 0 (0%) | 0 (0%) | 0 (0%) | 6 (16%) | 6 (16%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Peripheral sensory neuropathy | 9 (32%) | 0 (0%) | 9 (32%) | 0 (0%) | 0 (0%) | 2 (5%) | 0 (0%) | 2 (5%) | 0 (0%) | 0 (0%) |
| Platelet count decreased | 4 (14%) | 0 (0%) | 0 (0%) | 4 (14%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Pruritis | 8 (29%) | 4 (14%) | 4 (14%) | 0 (0%) | 0 (0%) | 6 (16%) | 0 (0%) | 6 (16%) | 0 (0%) | 0 (0%) |
| Rash maculopapular | 3 (11%) | 3 (11%) | 0 (0%) | 0 (0%) | 0 (0%) | 12 (32%) | 6 (16%) | 6 (16%) | 0 (0%) | 0 (0%) |
| Sore throat | 3 (11%) | 3 (11%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Vertigo | 3 (11%) | 3 (11%) | 0 (0%) | 0 (0%) | 0 (0%) | 3 (8%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Vomiting | 10 (36%) | 2 (7%) | 8 (29%) | 0 (0%) | 0 (0%) | 12 (32%) | 5 (14%) | 7 (18%) | 0 (0%) | 0 (0%) |
*
Serious Adverse Event reported in ≥ 10% of patients included Fever (n=10).
**
No grade 5 events were reported