Inavolisib for PIK3CA Mutated Advanced Endometrial Cancer: MITO END-4
ConditionEndometrial Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNational Cancer Institute, Naples
About this trial
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.
Eligibility criteria
Qualifiers
Signed informed consent prior to any study specific procedures.
Female, age ≥ 18 years at time of signing informed consent.
Patients with histologically or cytologically confirmed diagnosis of advanced, recurrent or metastatic endometrial carcinoma (endometrioid, serous, clear cell, carcinosarcoma or mixed histology).
Biomarker eligibility: valid results from testing of tumor tissue documenting PIK3CA mutations listed below (a-m); however, activating PIK3CA mutations not listed may also be included, capped at 20% of the study population.
Disqualifiers
Endometrial tumors with the following histologies: squamous carcinomas, sarcomas.
Prior treatment in locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K/AKT/mTOR pathway.
Any history of Type 1 diabetes and Type 2 diabetics patients with fasting blood glucose >140 and HbA1C ≥6.5%, and/or those that require 2 or more anti-diabetic agents should be excluded.
Subjects known to be positive for Human Immunodeficiency Virus (HIV).
Trial design
Treatments tested in this trial
- Inavolisib
Treatment groups
48 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov