Vevorisertib (ARQ 751) as a Single Agent or in Combination With Other Anti-Cancer Agents, in Solid Tumors With PIK3CA / AKT / PTEN Mutations (MK-4440-001)
Summary
The primary objectives of this study are: Part 1 - Vevorisertib as single agent: To assess the safety and tolerability of vevorisertib in participants with advanced solid tumors with v-Akt murine thymoma viral oncogene homolog (AKT) 1, 2, 3 genetic alterations, activating phosphatidylinositol-3-kinase (PI3K) mutations, phosphatase and tensin homolog deleted on chromosome ten (PTEN)-null, or other known actionable PTEN mutations; Part 2 - Vevorisertib in combination with other anti-cancer agents: To assess the safety and tolerability of vevorisertib in combination with paclitaxel or fulvestrant in participants with advanced, inoperable, metastatic and/or recurrent solid tumors with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) / PTEN actionable mutations and/or AKT genetic alterations.
Timeline
- Start
- 2016-06-26
- Primary completion
- 2021-03-10
- Completion
- 2021-03-10
Outcome
Outcome not reported
Stopped (Business): “Business Reasons”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fulvestrant | Small molecule | 500 mg | Intramuscular |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Vevorisertib | Small molecule | 5 mg | — |
| Subject | Vevorisertib | Small molecule | 10 mg | — |
| Subject | Vevorisertib | Small molecule | 20 mg | — |
| Subject | Vevorisertib | Small molecule | 25 mg | — |
| Subject | Vevorisertib | Small molecule | 50 mg | — |
| Subject | Vevorisertib | Small molecule | 75 mg | — |
| Subject | Vevorisertib | Small molecule | 100 mg | — |