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Inavolisib for PIK3CA Mutated Advanced Endometrial Cancer: MITO END-4

NCT07522697 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-04-13

No results posted yet for this study

Summary

MITO END-4 is a prospective, single arm, multicentric phase II trial aiming to assess whether Inavolisib is effective in the treatment of advanced endometrial carcinoma with pathogenic PIK3CA mutation. Approximately 48 patients with PIK3CA mutation will be overall enrolled in the study.

Conditions

Interventions

DRUG

Inavolisib

The planned starting dose for inavolisib will be 9 mg PO QD taken on Days 1-28 of each 28-day cycle. Dosing will continue until disease progression, unacceptable toxicity, or death. Specifically, the recommended starting dosage of inavolisib for patients with moderate renal impairment (CrCL 30 to \<60 mL/min) is 6 mg orally once daily.

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Anna Passarelli · National Cancer Institute, Naples

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2030-05-31
Completion
2030-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07522697 on ClinicalTrials.gov