Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01300026 | AMG 319 Lymphoid Malignancy FIH | PHASE1 | COMPLETED | 28 | — | — | Apr 1, 2011 | Dec 1, 2016 | Feb 9, 2017 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| Part II Dose Expansion | EXPERIMENTAL | Dose selected from Part I dose exploration |
| Part I Dose Exploration | EXPERIMENTAL | The AMG 319 doses proposed for this study are 25, 50, 100, 200, 300 and 400 mg administered by mouth once daily. |
| Name | Type | Description |
|---|---|---|
| AMG 319 | DRUG | AMG 319 is a highly selective, orally bioavailable and potent small molecule inhibitor of PI3Kδ. |
Inclusion Criteria: \- Part 1 (Dose Exploration): Relapsed or refractory lymphoid malignancy of the following type for which standard treatment does not exist or is no longer effective: B-cell Chronic Lymphocytic Leukemia (CLL) confirmed by immunophenotype or Non-Hodgkin Lymphoma: Low or intermedi...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520 / GEH200521 - Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | — | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |