Purpose of this Study
We are doing this study to find out if combining a drug called ipatasertib with the chemotherapy drug paclitaxel can help shrink or control solid tumors that have AKT gene mutations.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are enrolled in the ComboMATCH Registration Protocol (EAY191)</li>
<li>Have have locally advanced, unresectable, or metastatic malignancy</li>
<li>Have an activating AKT gene mutation (AKT1, AKT2, or AKT3)</li>
<li>Do not have an activating KRAS, NRAS, HRAS, or BRAF mutation</li></ul>
For more information about who can join this study, please contact the study team at nick.jeffries@duke.edu.
<li>Are enrolled in the ComboMATCH Registration Protocol (EAY191)</li>
<li>Have have locally advanced, unresectable, or metastatic malignancy</li>
<li>Have an activating AKT gene mutation (AKT1, AKT2, or AKT3)</li>
<li>Do not have an activating KRAS, NRAS, HRAS, or BRAF mutation</li></ul>
For more information about who can join this study, please contact the study team at nick.jeffries@duke.edu.
What is Involved?
If you choose to join this study, you will take ipatasertib by mouth days 1-21 of each drug cycle. You will also receive paclitaxel through a vein in your arm (IV) on days 1, 8, and 15 of each drug cycle. Each cycle lasts for 28 days. The number of cycles you do in this study will depend on how you respond to the study drug regimen.
Study Details
Full Title
EAY191-S3: Phase 2 Study of Paclitaxel (NSC #673089) + Ipatasertib (NSC #781451) in Taxane-Refractory Participants with AKT-Altered Advanced Non-Breast Solid Tumors: A ComboMATCH Treatment Trial
Principal Investigator
Niharika
Mettu
Protocol Number
PRO00114179
NCT ID
NCT05554380
Phase
II
Enrollment Status
Open to Enrollment