Ignite Creation Date:
2024-05-06 @ 8:32 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02761694
Status:
TERMINATED
Last Update Posted:
2023-05-06
First Post:
2016-04-29
Brief Title:
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
Sponsor:
ArQule Inc a subsidiary of Merck Sharp Dohme LLC a subsidiary of Merck Co Inc Rahway NJ USA
Organization:
ArQule Inc a subsidiary of Merck Sharp Dohme LLC a subsidiary of Merck Co Inc Rahway NJ USA
Study Overview
Official Title:
A Phase 1b Study of ARQ 751 as a Single Agent or in Combination With Other Anti-cancer Agents in Adult Subjects With Advanced Solid Tumors With PIK3CA AKT PTEN Mutations
Status:
TERMINATED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business Reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor recurrent solid tumors with phosphatidylinositol-45-bisphosphate 3-kinase catalytic subunit alpha PIK3CA PTEN actionable mutations andor AKT genetic alterations
Detailed Description:
This study was terminated due to business reasons and pharmacokinetic PK testing was prioritized
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ARQ 751-101 | OTHER | None | None |
| MK-4440-001 | OTHER | Merck | None |