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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02100852 | TGR-1202, a PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL) | PHASE1 | COMPLETED | 19 | — | — | Mar 12, 2014 | Nov 1, 2017 | Oct 2, 2019 | 2 | United States |
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
| Arm | Type | Description |
|---|---|---|
| TGR-1202 + Obinutuzumab + Chlorambucil | EXPERIMENTAL | TGR-1202 is an oral daily dose with obinutuzumab at a fixed IV infusion and chlorambucil as an oral dose on specified days. |
| Name | Type | Description |
|---|---|---|
| TGR-1202 + Obinutuzumab + Chlorambucil | DRUG | TGR-1202: Oral dose Obinutuzumab: IV infusion Chlorambucil: Oral dose |
Inclusion Criteria: * Confirmed Chronic Lymphocytic Leukemia (CLL) * Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 * Ability to swallow oral medication Exclusion Criteria: * Known hepatitis B virus, hepatitis C virus or HIV infection * Primary central nervous system lymphoma or known ...