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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03092934 | A Study of AK-01 (LY3295668) in Solid Tumors | PHASE1 | COMPLETED | 13 | — | — | May 29, 2017 | Apr 20, 2020 | Jul 2, 2021 | 3 | Canada |
Maximum Tolerated Dose (MTD) was defined as the dose immediately below the dose at which ≥2/3, ≥2/6, or ≥3/9 participants in a cohort experienced a dose limiting toxicity (DLT) during the first 21 days of treatment (Cycle 1) in Phase 1.
Objective response rate (ORR) was defined as a percentage of responders who achieved complete response or partial response (CR+PR) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1). Complete response (CR) is defined as disappearance of all target (and non-target) lesions, and no appearance of new lesion. Partial response (PR) was defined as at least a 30% decrease in the sum of longest diameters (LD) of target lesions, taking as reference the baseline sum of LD, no progression of non-target lesions, and no appearance of new lesions.
| Arm | Type | Description |
|---|---|---|
| 25 milligrams (mg) LY3295668 (Phase 1) | EXPERIMENTAL | 25 milligrams (mg) LY3295668 twice daily (BID) administered orally in 21-day cycles. |
| 50 mg LY3295668 (Phase 1) | EXPERIMENTAL | 50 mg LY3295668 BID administered orally in 21-day cycles. |
| 75 mg LY3295668 (Phase 1) | EXPERIMENTAL | 75 mg LY3295668 BID administered orally in 21-day cycles. |
| 25 mg LY3295668 (Phase 2) | EXPERIMENTAL | 25 mg LY3295668 BID administered orally in 21-day cycles. |
| Name | Type | Description |
|---|---|---|
| LY3295668 | DRUG | Oral capsules |
Inclusion Criteria: * Have received at least 1 but no more than 4 prior systemic therapies * Have adequate organ function * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale * Have estimated life expectancy greater than or equal to (≥)12 weeks * Have fully r...