Trials / Terminated
TerminatedNCT02761694
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)
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 78 (actual)
- Sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This study was terminated due to business reasons, and pharmacokinetic (PK) testing was prioritized.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vevorisertib | Administered as an oral dose every day or every other day. |
| DRUG | Fulvestrant | Administered as an intramuscular (IM) injection. |
| DRUG | Paclitaxel | Administered as an intravenous (IV) infusion. |
Timeline
- Start date
- 2016-06-26
- Primary completion
- 2021-03-10
- Completion
- 2021-03-10
- First posted
- 2016-05-04
- Last updated
- 2023-05-06
- Results posted
- 2022-06-15
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02761694. Inclusion in this directory is not an endorsement.