Table 1.
Studies included in the population PK analysis
| Study (phase) | Clinical Trials.gov identifier | Patient population | n a | Regimen | Ixazomib doseb (mg) |
|---|---|---|---|---|---|
| C16001 (I)c | NCT00830869 | Advanced non-hematologic malignancies | 80 | TW, IV, single agent | Dose escalation (0.2–4.8)d |
| C16002 (I)c | NCT00893464 | Lymphoma | 28 | W, IV, single agent | Dose escalation (0.23–6.8)d |
| C16003 (I)c | NCT00932698 | Relapsed and/or refractory MM | 52 | TW, PO, single agent | Dose escalation (0.4–4.8)d |
| C16004 (I)c | NCT00963820 | Relapsed and/or refractory MM | 51 | W, PO, single agent | Dose escalation (0.2–8.9)d |
| C16005 (I/II) | NCT01217957 | Newly diagnosed MM | 62 | W, PO, combination with len/dex | Phase I: dose escalation (2.9–10.6)d Phase II: 4.0 |
| C16007 (I) | NCT01318902 | Relapsed or refractory light-chain amyloidosis | 15 | W, PO, single agent | Dose escalation (4.0–5.5) |
| C16008 (I/II) | NCT01383928 | Newly diagnosed MM | 63 | TW, PO, combination with len/dex | Phase I: dose escalation (3.0–3.7) Phase II: 3.0 |
| C16010/TOURMALINE MM-1 (III) | NCT01564537 | Relapsed and/or refractory MM | 347 | W, PO, combination with len/dex | 4.0 |
| C16013 (I) | NCT01645930 | East Asian patients with relapsed and/or refractory MM | 43 | W, PO, combination with len/dex | 4.0 |
| TB-MC010034 (I) | NA | Japanese patients with relapsed and/or refractory MM | 14 | W, PO, single agent or combination with len/dex | 4.0 |
BSA body surface area, Dex dexamethasone, IV intravenous, Len lenalidomide, MM multiple myeloma, NA not applicable, PK pharmacokinetic, PO oral, TW twice-weekly: 21-day cycle with doses on days 1, 4, 8, 11; W weekly: 28-day cycle with doses on days 1, 8, 15
aPatients included in the population PK analysis
bNumbers in brackets show the range of starting doses administered to patients
cStudies included in the initial population PK analysis [13]
dBSA-based dosing