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NCT05300048 · ClinicalTrials.gov registry record · Phase 1

Combination of Serabelisib and Insulin Suppressing Diet With or Without Nab-paclitaxel in Subjects With Advanced Solid Tumors With PIK3CA Mutations

A Phase 1 study, sponsored by Faeth Therapeutics.

Terminated
Registry status
Phase 1
Development phase
34
Enrollment target

NCT05300048: Clinical Trial Phase 1 study, sponsored by Faeth Therapeutics.

NCT05300048 is a Phase 1 study that was terminated before completion, run by Faeth Therapeutics. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05300048, a Phase 1 study, was terminated before completion, sponsored by Faeth Therapeutics.

TERMINATED
Registry status
Phase 1
Development phase
34 participants
Enrollment target

Study Summary

This study will evaluate the feasibility of optimizing the safety and tolerability of serabelisib (an investigational PI3K inhibitor) when combined with an ISD and with or without nab-paclitaxel with a goal of reducing side effects and enhancing anticancer activity.

Primary Outcome

Incidence of related AEs

Interventions

  • DRUG Nab paclitaxel
  • DRUG Serabelisib
  • OTHER Insulin Suppressing Diet

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2022-04-22
Est. Completion 2025-04-30
Phase Phase 1
Faeth Therapeutics

5 total trials

Why NCT05300048 stopped before completion

NCT05300048 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).

The record links to 0 conditions, and to 3 interventions - of which Nab paclitaxel is the first listed.

NCT05300048 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05300048 about?

NCT05300048 is a clinical study titled "Combination of Serabelisib and Insulin Suppressing Diet With or Without Nab-paclitaxel in Subjects With Advanced Solid Tumors With PIK3CA Mutations". This study will evaluate the feasibility of optimizing the safety and tolerability of serabelisib (an investigational PI3K inhibitor) when combined with an ISD and with or without nab-paclitaxel with a goal of reducing side effects and enhancing anticancer activity.

What is the current status of trial NCT05300048?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2022-04-22. Estimated completion is 2025-04-30.

What interventions are being tested in trial NCT05300048?

The interventions under investigation include: Nab paclitaxel (DRUG), Serabelisib (DRUG), Insulin Suppressing Diet (OTHER).

Who is sponsoring clinical trial NCT05300048?

This trial is sponsored by Faeth Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05300048's enrollment target sits among peer trials

34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05300048, the US trial registry maintained by the National Library of Medicine. NCT05300048 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.