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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01705847 | A Phase 1b Study Evaluating GS-9820 in Subjects With Lymphoid Malignancies | PHASE1 | COMPLETED | 39 | — | — | Nov 1, 2012 | May 1, 2016 | May 17, 2016 | 4 | Netherlands |
MTD will be assessed to determine the appropriate dosing regimens for use in future clinical trials of GS-9820 in subjects with lymphoid malignancies.
| Arm | Type | Description |
|---|---|---|
| GS-9820 | EXPERIMENTAL | Participants will be sequentially enrolled at progressively higher dose levels to receive GS-9820 administered twice a day. Escalation will proceed to the maximum tolerated dose (MTD), defined as the highest tested dose associated with a rate of dose-limiting toxicities (DLT) of \< 33% during the first 4 weeks of therapy. |
| Name | Type | Description |
|---|---|---|
| GS-9820 | DRUG | GS-9820 tablets containing 200 mg of GS-9820 administered orally |
Inclusion Criteria: * Previously treated recurrent B-cell iNHL, DLBCL, MCL, HL or CLL * Measurable lymphadenopathy * Requires therapy Exclusion Criteria: * Recent history of a major non-lymphoid malignancy * Evidence of ongoing infection * Concurrent participation in another therapeutic clinical ...