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Glutaminase Inhibitor
IACS-6274 +/− Bevacizumab/Paclitaxel for Cancer
Phase 1
Recruiting
Led By Timothy A Yap, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with ARID1A mutant clear cell ovarian cancer
Female patients of childbearing potential, who are not post-menopausal or surgically sterile and intent to be sexually active with a non-sterile male partner, are required to use one form of highly effective contraception combined with a barrier method
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days
Awards & highlights
Study Summary
This trial is testing a new drug to see if it's safe and effective in treating patients with advanced solid tumors. The new drug, IACS-6274, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving IACS-6274 with or without pembrolizumab may help to control the disease.
Who is the study for?
Adults with advanced solid tumors, including specific types of ovarian, uterine, head and neck cancers, melanoma, and chondrosarcoma. Participants must have adequate organ function and no severe recent illnesses or treatments that could interfere with the study. They should not be at high risk for bleeding or infection and must use effective contraception if applicable.Check my eligibility
What is being tested?
The trial is testing IACS-6274 alone or in combination with other drugs like bevacizumab (which inhibits blood vessel growth in tumors), paclitaxel (a chemotherapy drug), or capivasertib (targets cancer cell growth). The goal is to find the highest dose patients can tolerate without significant side effects.See study design
What are the potential side effects?
Potential side effects include typical reactions to chemotherapy such as nausea, fatigue, hair loss; increased risk of infections; possible allergic reactions; issues related to liver function; nerve damage manifesting as numbness or tingling; and complications from affecting normal blood vessel formation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ovarian cancer is ARID1A mutant clear cell type.
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I am a woman able to have children, not menopausal or surgically sterile, and will use effective birth control.
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My ovarian cancer is high-grade, non-mucinous, platinum-resistant, and I've had less than 5 treatments.
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I am mostly active and haven't gotten worse in the past 2 weeks.
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I finished any cancer treatments 3 weeks ago or longer, and my side effects are minimal or stable.
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I will use a condom during the trial and for 16 weeks after if I'm sexually active.
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My cancer has low ASNS expression levels.
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I have head and neck cancer that has returned or continued after platinum-based chemotherapy.
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I've had at least one treatment for my advanced disease and can't use or didn't respond to standard treatments.
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My cancer is confirmed to be advanced and not just in one place.
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My organ functions are within normal ranges according to recent tests.
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My tumor has specific genetic changes (KEAP1/NFE2L2/STK11/NF1).
Select...
I have at least one tumor that can be measured by scans.
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I have been diagnosed with chondrosarcoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AEs)
Trial Design
3Treatment groups
Experimental Treatment
Group I: Part B (IACS-6274, bevacizumab, paclitaxel)Experimental Treatment3 Interventions
Patients receive IACS-6274 PO, paclitaxel IV, and bevacizumab IV throughout the study.
Group II: Part A (IACS-6274)Experimental Treatment1 Intervention
Patients receive IACS-6274 PO throughout the study.
Group III: PART C: (IACS-6274) with capivasertibExperimental Treatment2 Interventions
Patients receive IACS-627 PO, with capivasertib PO throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Paclitaxel
2011
Completed Phase 4
~5380
Capivasertib
2021
Completed Phase 1
~130
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,263 Total Patients Enrolled
22 Trials studying Endometrial Cancer
5,454 Patients Enrolled for Endometrial Cancer
Timothy A Yap, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
Timothy A YapPrincipal InvestigatorM.D. Anderson Cancer Center
9 Previous Clinical Trials
482 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received radiotherapy within the required timeframe before starting the study drug.You have had serious allergic reactions to monoclonal antibodies, a history of anaphylaxis, or uncontrolled asthma.My ovarian cancer is ARID1A mutant clear cell type.I am legally unable to make my own decisions.You have high levels of alkaline phosphatase in your blood.You have significant problems with how your body processes sugar.I have had immunotherapy for melanoma for at least 12 weeks.I have not had palliative radiotherapy recently.I am a woman able to have children, not menopausal or surgically sterile, and will use effective birth control.My ovarian cancer is high-grade, non-mucinous, platinum-resistant, and I've had less than 5 treatments.I do not have any serious heart conditions.I am not at a higher risk of bleeding due to other health conditions.I do not have any recent serious illnesses, especially heart-related.I haven't had major surgery in the last 28 days and don't expect any during the study.I am currently dealing with a serious infection.I am not on any cancer treatments or medications that could affect the study.I am HIV-positive but meet specific health criteria.I am mostly active and haven't gotten worse in the past 2 weeks.I finished any cancer treatments 3 weeks ago or longer, and my side effects are minimal or stable.I do not have severe or uncontrolled liver disease.I haven't taken strong drugs affecting liver enzymes recently.I will use a condom during the trial and for 16 weeks after if I'm sexually active.I haven't had cancer in the last 2 years, except for certain curable types.I cannot swallow pills without changing their form.You have had allergic reactions to similar drugs or substances as those used in the study.I am willing to follow all study requirements.I have not needed fluid removed from my abdomen in the last 2 weeks.I do not have any serious heart conditions.My cancer has low ASNS expression levels.I have head and neck cancer that has returned or continued after platinum-based chemotherapy.I've had at least one treatment for my advanced disease and can't use or didn't respond to standard treatments.I am a woman who cannot become pregnant.I can provide recent or stored tumor samples for testing.I do not have an active tuberculosis infection.You have a history of problems with alcohol or drug use.I haven't needed steroids for spinal or brain lining issues in the last 4 weeks.My cancer is confirmed to be advanced and not just in one place.My organ functions are within normal ranges according to recent tests.I do not have pre-existing nerve damage in my hands or feet.I do not have ongoing side effects from past cancer treatments.I have a primary brain tumor or symptoms from brain metastases.I am 18 or older and agree to participate in the study.My tumor has specific genetic changes (KEAP1/NFE2L2/STK11/NF1).I have at least one tumor that can be measured by scans.I have never had bowel obstruction, abdominal fistula, gastrointestinal perforation, or abscesses.I have not had another cancer, or if I have, it was treated over 5 years ago with no recurrence.I do not have an active hepatitis infection.I have been diagnosed with chondrosarcoma.You are allergic to the ingredients in capivasertib or any other parts of the product.You are allergic to paclitaxel or components of bevacizumab.You have too much protein in your urine, as shown by a specific test or urine dipstick.
Research Study Groups:
This trial has the following groups:- Group 1: Part B (IACS-6274, bevacizumab, paclitaxel)
- Group 2: PART C: (IACS-6274) with capivasertib
- Group 3: Part A (IACS-6274)
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.
How many individuals are participating in the experiment?
"Correct. Per the info on clinicaltrials.gov, this trial is in search of 36 participants at a single site and was first published on September 9th 2021 before being updated most recently on November 21st 2022."
Answered by AI
Could you outline the other experiments conducted with Glutaminase Inhibitor IPN60090?
"Globally, there are 961 studies associated with Glutaminase Inhibitor IPN60090. Of those trials, 122 have entered Phase 3 and are being conducted in Houston, Texas; however, 35731 other locations worldwide have opened up their facilities for this medication's clinical trial."
Answered by AI
What kind of adverse effects might one expect when taking Glutaminase Inhibitor IPN60090?
"The safety of this Glutaminase Inhibitor IPN60090 is only supported by limited data, prompting our team to assign it a score of 1."
Answered by AI
Is enrollment currently available for this experiment?
"Affirmative. Data from clinicaltrials.gov verifies that this research project, posted on 9/9/2021 and recently modified 11/21/2022 is currently seeking enrolment. In total 36 participants are needed at 1 site for the study to continue."
Answered by AI
What is the chief application of Glutaminase Inhibitor IPN60090?
"Glutaminase Inhibitor IPN60090 is frequently utilized to combat malignant neoplasms. Other illnesses that may benefit from this medication include microsatellite instability high, progressive disease after chemotherapy administration, and unresectable melanoma."
Answered by AI
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