Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AEB071 · 11 trials · 10 indications
Estimate the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of the AEB071and EVEROLIMUS combination therapy in patients with DLBCL.
Assess the preliminary evidence for anti-tumor activity at RP2D for AEB071 and EVEROLIMUS in patients with a CD79 mutation and those wild-type for the mutation but of the ABC subtype
| Arm | Type | Description |
|---|---|---|
| AEB071 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| AEB071 200 mg BID | EXPERIMENTAL | - |
| AEB071 400 mg OD | EXPERIMENTAL | - |
| AEB071 300 mg BID | EXPERIMENTAL | - |
| Placebo BID | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| Neoral | ACTIVE_COMPARATOR | - |
| AEB071 high dose with Cetican reduced dose | ACTIVE_COMPARATOR | - |
| AEB071 low dose with Cetican standard dose | ACTIVE_COMPARATOR | - |
| AEB071 and EVEROLIMUS | EXPERIMENTAL | AEB071 and EVEROLIMUS will be taken together in this open-label non-randomized study |
| Mycophenolic Acid / tacrolimus | ACTIVE_COMPARATOR | - |
| AEB071 / tacrolimus arm 1 | EXPERIMENTAL | - |
| AEB071 / tacrolimus arm 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AEB071 | DRUG | - |
| Placebo | DRUG | - |
| Certican | DRUG | twice daily |
| Neoral | DRUG | twice daily |
| Everolimus | DRUG | mTOR inhibitor |
| Mycophenolic Acid | DRUG | - |
Inclusion Criteria: * 18-75 years males and females * Female subjects of childbearing potential must be using two methods of contraception * Active, moderate to severe disease * Poor response to or no toleration of conventional therapy (e.g. steroids, mesalamine) * Good communication with the inves...
AEB071 is an investigational small molecule being studied for multiple conditions, including uveal melanoma, moderate and severe plaque psoriasis, de novo liver transplantation, uveitis, CD79 mutant or ABC-subtype diffuse large B-cell lymphoma, and kidney transplantation. It has been evaluated in clinical trials for these indications, though it is not approved.
AEB071 is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS. The company has sponsored clinical trials to investigate the safety and efficacy of AEB071 across various patient populations.
AEB071 has been studied in Phase 1 and Phase 2 clinical trials. The most advanced trials completed are Phase 2 studies for uveitis and plaque psoriasis. However, AEB071 remains investigational and is not approved for any use. All three completed trials are finished, with no active trials currently ongoing.
AEB071 has been evaluated in three completed clinical trials. NCT00416546 was a Phase 1 safety study in healthy volunteers. NCT00615693 was a Phase 2 trial for uveitis. NCT00885196 was a Phase 2 dose-finding study in plaque psoriasis. Additionally, NCT01430416 was a Phase 1 trial in metastatic uveal melanoma.
AEB071 is also known as sotrastaurin. This compound has been investigated under both names in clinical research. It is a small molecule that has been studied for its potential effects in various immune-mediated and oncologic conditions, though it is not yet approved.