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Serabelisib + Diet/Nab-paclitaxel for Solid Cancers
Study Summary
This trial will study if a drug combo is safe and effective with the goal of reducing side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have had 3 or fewer chemotherapy treatments for ovarian cancer.I have colorectal cancer and have had 2 or fewer treatments for it since it spread.My cancer has come back and was confirmed by a lab test.My liver function tests are within the required range.I have recurrent or persistent endometrial cancer of a specific cell type.I have been treated with a PI3K inhibitor.I have advanced cancer and cannot or will not use standard treatments.I have a solid tumor outside of the brain.I had chemotherapy or radiation less than 3 weeks ago and still have significant side effects.I have recurrent or persistent endometrial cancer of specific cell types.You have different types of solid tumors, such as endometrial adenocarcinoma or ovarian cancer, with specific histologic cell types.My ovarian cancer is the same type as described in Cohort 1b.I am fully active or can carry out light work.I have tried or can't take up to 3 treatments for my advanced cancer, or I refused standard treatment.I have tried or cannot try up to 3 treatments for my advanced cancer, or I refused standard treatment.I have severe gout that isn't controlled by treatment.I have used or might need to use acid reflux medication recently or during the study.I haven't taken antacids within 4 hours before starting serabelisib or don't expect to need them often during the study.I have had severe kidney stones that needed treatment by a specialist.My diabetes is not well-managed, with high blood sugar or HbA1c levels.I have a heart condition or significant heart disease.I have moderate to severe numbness, pain, or weakness in my hands or feet.I have severe constipation or a condition where worsening constipation would be harmful.You have experienced a severe allergic reaction in the past, particularly to certain foods, or have a medical condition (like celiac disease) that requires you to avoid certain foods.I have a specific type of recurrent or persistent endometrial or ovarian cancer.I am not pregnant and will use birth control during and after the study as advised.I haven't had a heart attack, stent placement, or severe chest pain in the last 6 months.My organs are working well.My cancer has returned and was confirmed by a lab test.I have refused all standard treatments available to me.I can take pills and follow the study's treatment plan.I have been diagnosed with a primary brain tumor.I have brain metastases or leptomeningeal disease that is either causing symptoms or has not been treated.I haven't taken strong CYP3A4 drugs in the last 7 days.I have taken H2 blockers within the last 24 hours.I have a serious blood vessel problem in my arms or legs.I have untreated or poorly controlled acid reflux.I do not have poorly controlled HIV, HBV, or HCV.A sample of your tumor tissue is needed for laboratory analysis to check for certain markers. If you agree to future studies, a few more tissue slides will be needed.You have other major health problems that could impact your ability to participate in the study.I use insulin or similar medications for my diabetes.You have been diagnosed with an eating disorder within the last 10 years.I haven't had treatment for another cancer, except some exceptions, in the last 2 years.I took nitrosoureas or mitomycin C less than 6 weeks ago, or a monoclonal antibody less than its half-life or 4 weeks ago.I have endometrial cancer and have had 3 or fewer chemotherapy treatments.My blood counts meet the required levels for neutrophils, platelets, and hemoglobin.My kidney function, measured by creatinine, is within normal limits.My blood clotting time is within the normal range, or properly managed if I'm on blood thinners.I am a man who is either surgically sterile or will use approved birth control during and for 3 months after the study.I am not on long-term steroids higher than 5 mg of prednisone daily, except for adrenal insufficiency.I have symptoms of not absorbing nutrients well.You are able to read and sign a document that explains the study and your participation in it.My cancer is in the colon or rectum.You are expected to live for at least 3 more months.You have severe malnutrition or an eating disorder that would make it difficult for you to follow a strict diet plan for a long period of time. Additionally, if your body mass index (BMI) is below 18.5, you will not be eligible.My tumor has a PIK3CA mutation.You have difficulty chewing, swallowing, or digesting most foods and liquids used in the study.My ovarian cancer is the same type as described in Cohort 1b.I am not willing to eat non-vegan or non-vegetarian food.My cancer is adenocarcinoma located in the colon or rectum.I am 18 years old or older.You have recently started a weight loss or diet plan in the past 10 days before starting the study drug.I am 18 years old or older.My tumor has a PIK3CA mutation, with or without PTEN loss.
- Group 1: Cohort 1a - Dose Modification without nab-paclitaxel
- Group 2: Cohort 1b - Dose Modification with Nab-Paclitaxel
- Group 3: Cohort 2 - Expansion Colorectal Cancer
- Group 4: Cohort 3 - Expansion Endometrial Cancer
- Group 5: Cohort 4 - Expansion Ovarian Clear Cell or Ovarian Endometrioid Carcinoma
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What number of health centers are administering this experiment?
"This trial is hosted at 13 different medical sites, such as Baptist Hospitals of Southeast Texas in Beaumont, University of Pennsylvania Health System, Perelman Center for Advanced Medicine in Philadelphia and Women's Cancer Research Network in Fresno."
What is the current participation rate in this research project?
"In order for this medical trial to commence, Faeth Therapeutics needs a total of 68 eligible patients. The study will be conducted at Baptist Hospitals of Southeast Texas in Beaumont, TX and the University of Pennsylvania Health System's Perelman Center for Advanced Medicine in Philadelphia, PA."
Has Serabelisib received regulatory authorization from the FDA?
"The safety rating of Serabelisib is 1, since it has only undergone Phase 1 trials and thus the efficacy and security data are still limited."
Are there any vacancies for participants in this research endeavor?
"Yes, the research team is actively searching for volunteers. The initial posting of this clinical trial occurred on April 22nd 2022 and it was last edited on October 6th 2022. 68 candidates are needed at 13 medical centres across the country."
What are the expected results of this research?
"The primary intent of this investigation, which will be tracked for up to 12 months until completion, is to evaluate the pharmacokinetic influence by measuring AUC in cohorts 1a/1b. Secondary goals include assessing population PK and intra-tumoural serabelisib concentration in tumour tissue (cohorts 2, 3, 4), antitumor efficacy via PFS measurement (Cohorts 1a/1b) and assessment of DCR - or disease control rate defined as CR + PR + stable disease (whichever occurs first)."
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