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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00415636 | Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer | PHASE1 | COMPLETED | 31 | — | — | Jan 1, 2007 | Jul 1, 2010 | Oct 19, 2018 | 1 | United States |
Summary tables of serious AEs (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.
| Arm | Type | Description |
|---|---|---|
| LY2603618 40 mg/m^2 (4.5-hour infusion) | EXPERIMENTAL | LY2603618 40 milligrams per square meter (mg/m\^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed. |
| LY2603618 40 mg/m^2 (1-hour infusion) | EXPERIMENTAL | Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m\^2 \[4.5-hour infusion\]), the LY2603618 40 mg/m\^2 dose in Cohort 2 (LY2603618 40 mg/m\^2 \[1-hour infusion\]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed. |
| LY2603618 70 mg/m^2 | EXPERIMENTAL | Beginning with Cohort 3 (LY2603618 70 mg/m\^2), dose modifications were allowed. LY2603618 70 mg/m\^2 was administered over the course of 1 hour. |
| LY2603618 105 mg/m^2 | EXPERIMENTAL | Cohort 4: LY2603618 105 mg/m\^2 administered over the duration of 1 hour. |
| LY2603618 150 mg/m^2 | EXPERIMENTAL | Cohort 5: LY2603618 150 mg/m\^2 administered over the duration of 1 hour. |
| LY2603618 195 mg/m^2 | EXPERIMENTAL | Cohort 6: LY2603618 195 mg/m\^2 administered over the duration of 1 hour. |
| Name | Type | Description |
|---|---|---|
| IC83/LY2603618 | DRUG | 40 mg/m\^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles. Dose finding study: dose is escalated after a minimum of 6 participants receive 40 mg/m\^2. |
| pemetrexed | DRUG | pemetrexed 500 mg/m\^2, intravenous (IV), Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles |
Inclusion Criteria: * Has at least one lesion that can be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) * Has fully recovered from all toxicities due to the following: 1. Local radiation therapy that ended at least 14 days prior to Cycle 1, Day 1. 2. Surgery. * Has a life ...
| 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 |