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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01648764 | A Study of LY2334737 in Participants With Cancer That is Advanced and/or Has Spread | PHASE1 | COMPLETED | 73 | — | — | Sep 1, 2008 | Nov 1, 2012 | Jun 17, 2019 | 4 | United States, France +1 |
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). The MTD was the highest dose level at which \<2 out of 6 participants experienced a dose-limiting toxicity (DLT) in Cycle 1. DLT was an adverse event (AE) during Cycle 1 that was likely related to LY2334737 and fulfilled any of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 nonhematological (except nausea/vomiting controlled with treatment); Grade 3 neutropenia with fever or any Grade 4 neutropenia with or without fever; Grade 3 thrombocytopenia with ≥Grade 2 bleeding or Grade 4 thrombocytopenia with or without bleeding; A recovery period longer than 14 days from last dose of LY2334737 to values allowing Cycle 2 to start; Other significant drug-related toxicity deemed by investigator to be dose limiting or that caused the participant to withdraw from the study. Pharmacokinetics and pharmacodynamics (PK/PD) were also taken into consideration for Phase 2 recommended dose.
| Arm | Type | Description |
|---|---|---|
| LY2334737 - Arm A | EXPERIMENTAL | LY2334737 administered orally at escalating doses \[40 milligrams (mg) - 200 mg\] every other day for 21 days followed by 7 days without study drug (28 day treatment cycle). Participants may receive additional treatment cycles until discontinuation criterion is met. |
| LY2334737 - Arm B | EXPERIMENTAL | LY2334737 administered orally at escalating doses (40 mg - 200 mg) every day for 7 days followed by 7 days without study drug then repeated (28 day treatment cycle). Participants may receive additional treatment cycles until discontinuation criterion is met. |
| Name | Type | Description |
|---|---|---|
| LY2334737 | DRUG | Administered orally |
Inclusion Criteria: * Diagnosis of advanced and/or metastatic cancer (including lymphoma) for which no treatment of higher priority exists * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Estimated life expectancy of more than 12 weeks * Have discontinued all previous therapies ...