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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 12 months.
Awards & highlights

Study Summary

This trial will study if a drug combo is safe and effective with the goal of reducing side effects.

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.Check my eligibility
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.See study design
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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I have recurrent or persistent endometrial cancer of specific cell types.
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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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My ovarian cancer is the same type as described in Cohort 1b.
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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 cancer has returned and was confirmed by a lab test.
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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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My tumor has a PIK3CA mutation.
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My cancer is adenocarcinoma located in the colon or rectum.
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I am 18 years old or older.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohorts 1a/1b: Evaluate compliance
Cohorts 1a/1b: Evaluate safety
Impacted tooth
+3 more
Secondary outcome measures
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 outcome measures
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

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
~70

Find a Location

Who is running the clinical trial?

Faeth TherapeuticsLead Sponsor
2 Previous Clinical Trials
60 Total Patients Enrolled
Vicky MakkerPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
28 Total Patients Enrolled

Media Library

Serabelisib (PI3K inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05300048 — Phase 1
PTEN Mutation Research Study Groups: Cohort 1a - Dose Modification without nab-paclitaxel, Cohort 1b - Dose Modification with Nab-Paclitaxel, Cohort 2 - Expansion Colorectal Cancer, Cohort 3 - Expansion Endometrial Cancer, Cohort 4 - Expansion Ovarian Clear Cell or Ovarian Endometrioid Carcinoma
PTEN Mutation Clinical Trial 2023: Serabelisib Highlights & Side Effects. Trial Name: NCT05300048 — Phase 1
Serabelisib (PI3K inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05300048 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI
~12 spots leftby Sep 2024