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Adjusted LOA
ML Risk
Also known as sotrastuarin
AEB071 · 9 trials · 9 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 has been studied in several conditions, including CD79 mutant or ABC-subtype diffuse large B-cell lymphoma, uveal melanoma, moderate and severe plaque psoriasis, and uveitis. It is an investigational small molecule developed by Novartis AG and is not approved for any indication.
AEB071 is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is the sponsor of the clinical trials evaluating AEB071 in lymphoma, uveal melanoma, psoriasis, and uveitis.
AEB071 is in Phase 1 and Phase 2 clinical development. The most advanced completed trials were Phase 2 studies in plaque psoriasis and uveitis, while the lymphoma and uveal melanoma studies were Phase 1. No active trials are currently listed.
AEB071 has been evaluated in completed trials including NCT01854606 in CD79 mutant or ABC-subtype diffuse large B-cell lymphoma, NCT01430416 in metastatic uveal melanoma, NCT00885196 in moderate and severe plaque psoriasis, and NCT00615693 in uveitis. All four studies have been completed.
AEB071 is not approved by the FDA. It remains an investigational small molecule in clinical development, with completed Phase 1 and Phase 2 trials in lymphoma, uveal melanoma, psoriasis, and uveitis. No regulatory approval has been granted for any indication.
AEB071 was studied in patients with CD79 mutant or ABC-subtype diffuse large B-cell lymphoma in a completed Phase 1 trial, NCT01854606, which enrolled 31 patients across the United States, Europe, and Asia. The study evaluated AEB071 in combination with everolimus.