Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AVL-292 · 2 trials · 4 indications
Number of participants with adverse events
Maximum observed concentration in plasma
Area under the plasma concentration-time curve
| Arm | Type | Description |
|---|---|---|
| 50 mg of AVL-292 and Placebo | EXPERIMENTAL | 50 mg AVL-292 (2 x 25 mg AVL-292 capsules and 6 placebo capsules) once daily for 7 days administered orally under fasted condition |
| 100 mg of AVL-292 and Placebo | EXPERIMENTAL | 100 mg AVL-292 (4 x 25 mg AVL-292 capsules and 4 placebo capsules) once daily for 7 days administered orally under fasted condition |
| 200 mg AVL-292 | EXPERIMENTAL | 8 x 25 mg AVL-292 capsules orally once daily for 7 days under fasted condition |
| 350 mg of AVL-292 | EXPERIMENTAL | 350 mg AVL-292 (14 x 25 mg AVL-292 capsules) once daily for 7 days administered orally under fasted condition |
| Placebo - 8 capsules | PLACEBO_COMPARATOR | 8 placebo capsules once daily for 7 days administered orally under fasted condition |
| Placebo - 14 capsules | PLACEBO_COMPARATOR | 14 placebo capsules once daily for 7 days administered orally under fasted condition |
| AVL-292 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 50 mg AVL-292 | DRUG | - |
| 100 mg AVL-292 | DRUG | - |
| 200 mg AVL-292 | DRUG | - |
| 350 mg AVL-292 | DRUG | - |
| Placebo capsules | DRUG | - |
| AVL-292 | DRUG | 125 mg to 625 mg orally, once a day, for 28 days (28 days equals 1 cycle). Number of cycles: until progression or unacceptable toxicity develops |
Inclusion Criteria: * Healthy male or female subjects of any ethnic origin between ages of 18 and 65 with a body mass index between 18 and 33 Exclusion Criteria: * Recent history (i.e., within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, card...
AVL-292 is an investigational small molecule being studied for use in B Cell Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia. It has also been studied in healthy volunteers to assess safety and pharmacokinetics. The drug is in Phase 1 clinical development and is not yet approved.
AVL-292 is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with certain B cell malignancies.
AVL-292 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in patients with relapsed or refractory B cell malignancies and another in healthy volunteers. The drug is investigational and has not received regulatory approval.
AVL-292 has been studied in two completed Phase 1 trials. NCT01351935 evaluated escalating doses in patients with relapsed or refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia. NCT01692184 assessed safety and pharmacokinetics following multiple doses and the effect of food in healthy volunteers.
AVL-292 is a distinct investigational small molecule developed by Bristol-Myers Squibb. No alternative names for AVL-292 have been reported in the clinical trial data. It is being studied specifically for B cell malignancies and in healthy volunteer pharmacokinetic studies.