Ipatasertib for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a drug called ipatasertib to determine its effectiveness in treating cancers with specific genetic changes known as AKT mutations. Ipatasertib aims to stop cancer cells from growing and potentially kill them. Suitable candidates for this trial have cancer with an AKT mutation, excluding breast cancer, and should not have certain other genetic mutations like KRAS or BRAF. The trial excludes individuals with a history of inflammatory bowel diseases or those who have previously taken similar treatments. Participants will take ipatasertib daily in cycles and undergo regular scans and tests to monitor progress. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot have taken strong inhibitors or inducers of CYP3A4/5 within 2 weeks before starting the study. If you have castration-resistant prostate cancer, you should continue your current treatment with GnRH agonists or surgical castration, and you can continue abiraterone acetate/prednisone if you just progressed on it.
Is there any evidence suggesting that ipatasertib is likely to be safe for humans?
Research has shown that ipatasertib is generally well-tolerated by patients. One study found that when combined with treatments like palbociclib and fulvestrant, the side effects were expected and manageable with standard care.
Another study involving patients with specific genetic mutations reported that most of the 50 participants tolerated the treatment without severe issues. Although some side effects occurred, they were manageable for most.
Ipatasertib has also been tested in men with prostate cancer. When combined with abiraterone, it effectively slowed disease progression. The side effects were significant but expected, and doctors managed them well.
Overall, ipatasertib has demonstrated a consistent safety record across different studies. While side effects can occur, they are usually manageable. Patients should consult a healthcare provider to understand how this treatment might affect them.12345Why do researchers think this study treatment might be promising?
Ipatasertib is unique because it targets a specific protein called Akt, which is involved in cancer cell growth and survival. Unlike traditional chemotherapy, which attacks rapidly dividing cells indiscriminately, ipatasertib is more selective, potentially leading to fewer side effects. Researchers are excited about this treatment because it offers a more targeted approach, potentially improving outcomes for patients with certain cancers that have been resistant to other treatments.
What evidence suggests that ipatasertib might be an effective treatment for cancer?
Research has shown that ipatasertib, the treatment under study in this trial, may help treat certain cancers with AKT mutations. In previous studies, adding ipatasertib to other cancer treatments reduced the risk of progression in prostate cancer patients. It also prolonged the period before breast cancer worsened when combined with fulvestrant. Evidence indicates that it works well against some cancers, such as endometrial cancer, when tumors have specific AKT mutations. These findings suggest that ipatasertib could be effective for certain cancers with these genetic changes.24678
Who Is on the Research Team?
Kevin M Kalinsky
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
This trial is for cancer patients with AKT genetic changes. It's open to those with multiple myeloma, various types of lymphoma, or solid tumors. Participants must have specific mutations and meet other health criteria not specified here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ipatasertib orally once daily on days 1-28 of each 28-day cycle. Cycles repeat in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up includes imaging and clinical assessments.
What Are the Treatments Tested in This Trial?
Interventions
- Ipatasertib
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor