What side effects are associated with this type of intervention?

Common side effects of treatments for PTEN mutations, particularly with PI3K inhibitors like Serabelisib, include gastrointestinal issues such as diarrhea and nausea, skin reactions like rash, and metabolic disturbances including hyperglycemia. These side effects are consistent with those observed in other PI3K inhibitors and targeted therapies.

What prior FDA approvals exist?

There are no specific FDA approvals mentioned in the provided context for the treatment of PTEN mutations using PI3K inhibitors like serabelisib. However, PI3K inhibitors are a class of drugs being investigated for their potential in treating various cancers with mutations in the PI3K pathway, which includes PTEN mutations. Other drugs in this class, such as alpelisib, have been approved for use in combination with endocrine therapy for certain types of breast cancer with PIK3CA mutations, which are related to the PI3K pathway.

What other types of research exist?

Promising alternatives to Serabelisib for PTEN mutation patients include mTOR inhibitors like Everolimus, AKT inhibitors such as Capivasertib, and immunotherapies targeting PD-1/PD-L1 pathways, including Pembrolizumab and Nivolumab. These treatments have shown potential in clinical trials and may offer effective options for patients with PTEN mutations.

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PI3K inhibitor

Serabelisib + Diet/Nab-paclitaxel for Solid Cancers

Phase 1

Waitlist Available

Led By Vicky Makker

Research Sponsored by Faeth Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cohort 2 (subjects with colorectal cancer): Have failed no more than 2 prior LOT for metastatic CRC.

Histologically or cytologically confirmed recurrent solid tumors.

Must not have

Has had serabelisib, alpelisib, or other PI3K inhibitor.

Is less than 21 days from therapeutic radiation or chemotherapy prior to the first day of dosing with Study Drug and has not recovered to Grade ≤ 1 from all clinically significant toxicities related to prior therapies.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 12 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug called serabelisib with a special diet that lowers insulin levels, and sometimes with another drug called nab-paclitaxel. nab-Paclitaxel is used for treating triple-negative breast cancer. It targets cancer patients who suffer from severe side effects of current treatments. The goal is to block cancer growth pathways and lower insulin to reduce side effects and improve treatment effectiveness.

Who is the study for?

Adults with advanced solid tumors harboring PIK3CA mutations, who have tried and failed or were intolerant to a limited number of previous treatments. They must be able to consent, have a life expectancy over 3 months, adequate organ function, and no severe comorbidities. Women must not be pregnant and agree to use birth control; men must also agree to contraception.

What is being tested?

The trial is testing the combination of Serabelisib (a PI3K inhibitor) with an Insulin Suppressing Diet (ISD), both alone and alongside Nab-paclitaxel chemotherapy. The goal is to improve safety, reduce side effects, and enhance cancer-fighting efficacy in patients with specific genetic tumor profiles.

What are the potential side effects?

Potential side effects include those common to chemotherapy like fatigue, hair loss, nerve damage (neuropathy), as well as possible digestive issues from the ISD. Serabelisib may cause immune-related reactions or worsen diabetes control due to its effect on insulin levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have colorectal cancer and have had 2 or fewer treatments for it since it spread.

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My cancer has come back and was confirmed by a lab test.

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My liver function tests are within the required range.

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I have a solid tumor outside of the brain.

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You have different types of solid tumors, such as endometrial adenocarcinoma or ovarian cancer, with specific histologic cell types.

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I am fully active or can carry out light work.

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I have tried or can't take up to 3 treatments for my advanced cancer, or I refused standard treatment.

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I have a specific type of recurrent or persistent endometrial or ovarian cancer.

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My blood counts meet the required levels for neutrophils, platelets, and hemoglobin.

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My kidney function, measured by creatinine, is within normal limits.

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My cancer is in the colon or rectum.

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I am 18 years old or older.

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My tumor has a PIK3CA mutation, with or without PTEN loss.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with a PI3K inhibitor.

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I had chemotherapy or radiation less than 3 weeks ago and still have significant side effects.

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I have severe gout that isn't controlled by treatment.

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I have used or might need to use acid reflux medication recently or during the study.

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I have had severe kidney stones that needed treatment by a specialist.

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My diabetes is not well-managed, with high blood sugar or HbA1c levels.

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I have a heart condition or significant heart disease.

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I have moderate to severe numbness, pain, or weakness in my hands or feet.

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I have severe constipation or a condition where worsening constipation would be harmful.

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I haven't had a heart attack, stent placement, or severe chest pain in the last 6 months.

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I have been diagnosed with a primary brain tumor.

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I have brain metastases or leptomeningeal disease that is either causing symptoms or has not been treated.

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I haven't taken strong CYP3A4 drugs in the last 7 days.

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I have a serious blood vessel problem in my arms or legs.

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I have untreated or poorly controlled acid reflux.

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I do not have poorly controlled HIV, HBV, or HCV.

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I use insulin or similar medications for my diabetes.

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I am not on long-term steroids higher than 5 mg of prednisone daily, except for adrenal insufficiency.

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I have symptoms of not absorbing nutrients well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 12 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 12 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 12 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cohorts 1a/1b: Evaluate compliance

Cohorts 1a/1b: Evaluate safety

Impacted tooth

+3 more

Secondary study objectives

Cohort 2, 3, 4: Additional assessments of antitumor efficacy of study intervention (Measuring DCR).

Cohort 2, 3, 4: Additional assessments of antitumor efficacy of study intervention (Measuring DoR).

Cohort 2, 3, 4: Additional assessments of antitumor efficacy of study intervention (Measuring OS).

+9 more

Other study objectives

Cohorts 1a/1b, 2, 3, 4: Assessment of PD of study intervention.

Cohorts 1a/1b, 2, 3, 4: Assessment of genetic predictors of efficacy.

Cohorts 1a/1b, 2, 3, 4: Assessment of genetic predictors of toxicity.

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Cohort 4 - Expansion Ovarian Clear Cell or Ovarian Endometrioid CarcinomaExperimental Treatment3 Interventions

Subjects will receive dose of serabelisib as determined from Cohorts 1a and 1b, and will consume Insulin Suppressing Diet for up to 12 months. If results from Cohort 1b show a favorable risk-benefit ratio, nab-paclitaxel will be administered intravenously weekly.

Group II: Cohort 3 - Expansion Endometrial CancerExperimental Treatment3 Interventions

Subjects will receive dose of serabelisib as determined from Cohort 1a and 1b, and will consume Insulin Suppressing Diet for up to 12 months. If results from Cohort 1b show a favorable risk-benefit ratio, nab-paclitaxel will be administered intravenously weekly.

Group III: Cohort 2 - Expansion Colorectal CancerExperimental Treatment2 Interventions

Subjects will receive dose of serabelisib as determined from Cohort 1a and 1b, and will consume Insulin Suppressing Diet for up to 12 months

Group IV: Cohort 1b - Dose Modification with Nab-PaclitaxelExperimental Treatment3 Interventions

Subjects with endometrial cancer, ovarian clear cell or ovarian endometriod carcinoma will receive multiple doses of serabelisib administered orally and will consume Insulin Suppressing Diet for up to 12 months. In addition, these subjects will receive nab-paclitaxel intravenously weekly.

Group V: Cohort 1a - Dose Modification without nab-paclitaxelExperimental Treatment2 Interventions

Subjects with any solid tumor will receive multiple doses of serabelisib administered orally and will consume Insulin Suppressing Diet for up to 12 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nab paclitaxel

2014

Completed Phase 2

~580

0 / 32Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

PTEN mutations often lead to the activation of the PI3K/AKT/mTOR pathway, promoting tumor growth and survival. Treatments targeting this pathway, such as PI3K inhibitors like Serabelisib, work by inhibiting the PI3K enzyme, thereby reducing downstream signaling that drives cancer cell proliferation and survival. This is crucial for PTEN mutation patients as it directly addresses the aberrant signaling caused by the loss of PTEN function, potentially leading to better control of tumor growth and improved clinical outcomes.