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Anti-metabolites
Ipatasertib + Chemotherapy for Cancer
Phase 2
Recruiting
Led By Reva K Basho
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial tests if adding a targeted therapy to chemotherapy can help people with solid tumor cancers.
Who is the study for?
Adults with solid tumors that can't be surgically removed, have spread, and show an AKT genetic mutation. They must have progressed after taxane-based therapy within 6 months and meet specific health criteria including organ function tests. Excluded are those who've had prior AKT inhibitors, certain mutations, uncontrolled illnesses or bowel inflammation, or are pregnant.Check my eligibility
What is being tested?
The trial is testing the combination of chemotherapy (paclitaxel) with a targeted drug called Ipatasertib in patients whose solid tumors carry an AKT mutation. The goal is to see if this combo can shrink these cancers or stop their growth more effectively than standard treatments.See study design
What are the potential side effects?
Possible side effects include reactions to Ipatasertib such as diarrhea and rash; paclitaxel may cause nerve damage, allergic reactions, muscle pain. Both drugs could potentially affect blood counts leading to increased infection risk and might cause liver issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Duration of response
Overall survival
Progression free survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (paclitaxel, ipatasertib)Experimental Treatment6 Interventions
Patients receive paclitaxel IV on days 1, 8, and 15 and ipatasertib PO on days 1-21. Treatment repeats every 28 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI and blood collection throughout the trial. Patients also undergo a tumor biopsy during screening and follow-up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Biopsy
2014
Completed Phase 4
~1090
Ipatasertib
2011
Completed Phase 3
~2320
Paclitaxel
2011
Completed Phase 4
~5380
Biospecimen Collection
2004
Completed Phase 2
~1700
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,664 Previous Clinical Trials
40,925,973 Total Patients Enrolled
Reva K BashoPrincipal InvestigatorSWOG Cancer Research Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can swallow pills without any issues.My condition did not worsen within 6 months after receiving taxane-based therapy.I have not been diagnosed with a solid tumor cancer other than breast cancer.I am not planning to receive any other cancer treatments while on this study.I do not have spinal cord compression or brain tumors, or they are being successfully treated.I am not taking drugs that affect CYP3A enzyme activity.My heart is functioning well.I had a physical exam within the last 28 days.I do not have active inflammation in my intestines.I have never taken AKT inhibitor medications.My cancer is not advanced or spread to the point where surgery isn't possible.I do not have cancer that has spread to the lining of my brain and spinal cord.I am 18 years old or older.My fasting blood sugar was below 160 mg/dL in the last 28 days.I do not have any other cancer that could affect this treatment's safety or results.I do not have a severe ongoing illness that is not under control.I can take care of myself and am up and about more than 50% of my waking hours.My kidneys are functioning well, with a creatinine clearance rate of at least 50 mL/min.I had hepatitis C but am now cured or have no detectable virus.My cancer has an AKT mutation according to the ComboMATCH test.I agree to a biopsy or have tissue samples from the last 12 months.My neuropathy symptoms are mild or have improved within the last two weeks.I do not have lung disease needing ongoing treatment that increases my risk from study treatments.My brain metastases have not worsened in the last 42 days.I do not have uncontrolled high cholesterol or triglycerides.I have chronic hepatitis B but my viral load is undetectable.My cancer does not have mutations in KRAS, NRAS, HRAS, or BRAF genes.My side effects from previous treatments are mild or gone, except for hair loss.I do not have any ongoing infections needing strong medication or procedures.I do not have any specific liver conditions.I am enrolled in EAY191 and assigned to ComboMATCH for EAY191-S3 due to a specific mutation.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (paclitaxel, ipatasertib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment still occurring for this scientific experiment?
"According to the information on clinicaltrials.gov, this trial is actively recruiting participants. It was initially posted on March 6th 2023 and most recently modified a week later on March 16th of that same year."
Answered by AI
How many participants have taken part in this trial up to now?
"Yes, according to the information provided on clinicaltrials.gov this study is still actively recruiting patients. It was first announced on March 6th 2023 and its most recent update took place just 10 days later. Currently 33 participants are being sought between 2 different enrolled sites."
Answered by AI
Are patients at risk of any adverse effects from the combination of paclitaxel and ipatasertib?
"Our internal evaluation has concluded that Treatment (paclitaxel, ipatasertib) can be considered moderately safe since it is only in Phase 2 of clinical trials. While safety data exists, there are no findings yet regarding its efficacy."
Answered by AI
Who else is applying?
What state do they live in?
Washington
What site did they apply to?
Valley Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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