Trial | Efficacy Results | Grade ≥ 3 AEs in ≥ 5% of Patients | Other |
---|---|---|---|
Single-arm trial (N = 55 total; | mPFS = 84 weeks* SD = 53.3%†PR = 23.3%†DCR = 76.6%†OS = 140 weeks†| Hypertension (13%), hand-foot syndrome (10%), rash (10%), weight loss (10%), diarrhea (7%), elevated LFTs (7%)‡ | • Dose reduction (due to AEs) was required in 47% of patients (initial analysis) • Median duration of treatment at initial analysis (30 of 55 patients accrued) = 27 weeks • BRAF genotyping (n = 16): mPFS = 84+ weeks in DTC patients with BRAFV600E, compared with 54 weeks in those with BRAFwt (P = 0.028) |
Single-arm component (chemotherapy-naive patients with DTC) of two-arm trial (N = 56 total; n = 41 DTC) [13] | mPFS = 65 weeks* SD = 57%* PR = 15%* DCR = 72%* | Fatigue, HSFR (11% each); weight loss, skin rash, hypertension, diarrhea, stomatitis, tongue/tooth pain, abdominal/rectal pain, proximal myopathy, back pain, general pain, hand/foot pain, arthralgia, colon perforation (5% each) | • Dose reduction (due to AEs) was required in 52% of patients |
Single-arm trial (N = 26 total; | mPFS not reported SD = 82%†PR = 18%†DCR = 100%†| Hand-foot syndrome (19%), other skin toxicity (6%), hypertension (6%), infection (8%) | • Dose reduction (due to AEs) was required in 62% of patients • Five drug-related serious AEs were reported: 2 hospitalizations for non-neutropenic fever/infection, 1 for hypocalcemia, and 2 for fever/rash |
Single-arm trial (N = 31; all DTC) [16] | mPFS = 58 weeks SD = 34% PR = 25% DCR = 59% | HFSR (22%), hypertension (16%), weight loss (9%) | • Dose reduction (due to AEs) was required in 56% of patients |