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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01214668 | Dose-Escalation Study of LY573636-sodium and Liposomal Doxorubicin in Patients With Advanced Solid Tumors | PHASE1 | COMPLETED | 31 | — | — | Jan 1, 2009 | Feb 1, 2012 | Jan 4, 2019 | 5 | United States |
| NCT01215916 | A Phase 1 Study in Patients With Solid Tumors | PHASE1 | COMPLETED | 39 | — | — | Feb 1, 2008 | Dec 1, 2011 | Mar 15, 2019 | 1 | United States |
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD), which is corrected for the participant's predose albumin to identify the albumin-corrected exposure range of LY 573636 when combined with liposomal doxorubicin. MTD is the highest dose with \<33% of participants having a dose-limiting toxicity (DLT) in the first 28-day cycle of treatment. DLT is an adverse event (AE) that is likely related to the study drug or combination and fulfills any 1 of the following: Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 hematologic toxicity; Gr 3 nonhematologic toxicity (excluding controllable nausea/vomiting or diarrhea and alopecia); Gr 3 electrolyte toxicity that is not resolved with standard treatments. Those who enter the study with Gr 2 hepatic enzyme abnormalities, DLT for an isolated Gr 3 hepatic enzyme abnormality is determined by investigators; a DLT can be declared if a participant experiences increasing toxicity during treatment.
| Arm | Type | Description |
|---|---|---|
| LY573636 + Liposomal Doxorubicin | EXPERIMENTAL | - |
| Experimental: Pemetrexed followed by LY573636 | EXPERIMENTAL | Pemetrexed on Day 1 followed by LY573636 on Day 4 |
| Experimental: LY573636 followed by Pemetrexed | EXPERIMENTAL | LY573636 on Day 1, pemetrexed on Day 4 |
| Experimental: LY573636 and Pemetrexed on Day 1 | EXPERIMENTAL | LY573636 and Pemetrexed on Day 1 |
| Name | Type | Description |
|---|---|---|
| LY573636-sodium | DRUG | Individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28-day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, cumulative dose of 550 milligrams per square meter (mg/m²) of liposomal doxorubicin or doxorubicin is reached, or other withdrawal criterion is met. |
| Liposomal Doxorubicin | DRUG | 40 mg/m² on Day 1, given intravenously of each 28-day cycle Participants may continue on study drug until disease progression, unacceptable toxicity, cumulative dose of 550 mg/m² of liposomal doxorubicin or doxorubicin is reached, or other withdrawal criterion are met. |
| LY573636 | DRUG | Individualized dose is dependent on a patient's height, weight, and gender and is adjusted to target a specific exposure range corrected for a patient's laboratory parameters. Intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days). Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Patients are pretreated with folic acid \[350 micrograms (µg) to 1000 µg orally, daily\], Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone \[4 milligrams (mg) orally, twice daily or equivalent\]. |
| Pemetrexed | DRUG | 375 to 500 milligrams per square meter (mg/m\^2), intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days). Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Patients are pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). |
Inclusion Criteria: * You must have a histologically confirmed solid malignancy that is unresectable and/or metastatic which has progressed after receiving standard approved chemotherapy * You must have a solid malignancy for which an anthracycline-based regimen is felt to be a reasonable treatment...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |