Table 2.
Completed clinical trials with capivasertib in breast cancer.
| Trial | Registration no. | Phase | Study population | Participants | Treatment regimens | Results | Ref. |
|---|---|---|---|---|---|---|---|
| STAKT | NCT02077569 | 2 | ER-positive invasive breast cancer | 48 | Capivasertib 480, 240, 360 mg bid | Significant percentage reductions in biomarkers −39% (P = 0.006) for pGSK3β and −50% (P < 0.0001) for pPRAS40 and percentage reduction in ki67 at 480 mg dose bid Milder dose- and concentration-dependent reductions in the biomarkers at doses of 240 and 360 mg bid |
[15] |
| NCT04712396 | 1 | Healthy Volunteers | 11 | Capivasertib plus Itraconazole | Not Reported | – | |
| [42] | NCT01353781 | 1 | Advanced Solid Tumors | 41 | Capivasertib 80, 240, 320, 400 mg bid continuously or 360, 480 mg bid 4-days-on/3-days-off or 640 mg bid 2-days-on/5-days-off | (2/37) had PR; 27% (10/37) had SD with duration of 46–360 days. TRAEs (97.6%): diarrhea (78%), hyperglycemia (68.3%), nausea (56.1%), maculopapular rash (56.1%), pyrexia (48.8%), stomatitis (41.5%) TRAEs grade3/4 (63.4%): hyperglycemia (39%), diarrhea (17.1%) |
[33] |
| ComPAKT | NCT02338622 | 1 | Advanced Solid Tumors | 64 | Capivasertib 320, 400, 480 mg bid 4-days-on/3-days-off and 480 mg, 560 mg and 640 mg bid 2-days-on/5-days-off plus Olaparib | 400 mg bid 4/3 and 640 mg bid 2/5 were chosen for the dose expansion phase 8/18 (44%) achieved clinical benefit; 6 patients had PR and 2 patients had SD. Median DOR: 38.2 (14.9–80.9) 5/7 of BRCA1/2 mutated patients achieved clinical benefit; Median DOR: 39.1 (14.9–80.9) TRAEs: nausea (67%), diarrhea (55%), vomiting (41%), fatigue (51%), anemia |
[37] |
| OAK trial | NCT01895946 | 1 | Advanced Solid Tumors | 33 | Capivasertib 480 mg bid 4-days-on/3-days-off tablet or capsule in a fast or fed state | Faster absorption from the tablet than from the capsule (tmax: 1.0 (0.6–2) vs 2.0 (1–4) Similar AUCτ and Cmax between the AZD5363 tablet and capsule Lower absorption rate in the fed vs fasted state (tmax: 2.0 (2–4.3) Vs 0.6 (0.5–4)) Lower and later peak concentrations in the fed vs fasted state |
[16] |
AE: adverse event; TRAE: treatment-related adverse event; bid: twice a day; PR: partial response; CR: complete response; SD: stable disease; HR: hazard ratio; CI: confidence interval; OS: overall survival; DOR: duration of response; Ref.:reference.