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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Inavolisib
DrugThe 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.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: InavolisibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR)
a complete response (CR) or partial response (PR) by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST1.1) criteria.
Time frame
Every 8 (±1) weeks during the first 2 years, every 12 (±1) weeks therafter, from enrollment until disease progression (up to 48 months).Secondary outcomes
1
progression-free survival (PFS) at 6 months
6 months PFS probability will be calculated using Kaplan-Meyer method and reported with relative 95% CI. PFS is defined as the time elapsing between the registration of the patient and the progression of the disease or the death for any cause, whichever occurs first. Patients alive and without objective disease progression will be censored at the last tumor assessment
Time frame
from enrollment to 6 months2
disease-control rate (DCR)
It will be reported as absolute frequency, percentage e relative 95% CI. DCR is defined as the proportion of subjects with CR, PR, or stable disease (SD) for at least 2 assessements.
Time frame
from enrollment until disease progression (up to 48 months)3
duration of response (DoR)
The DoR analysis will include only responders. DoR will be described according to the Kaplan- Meier method. DoR is defined as the duration from the first documented response to the date of progression or death due to any cause. In case a subject does not have progression or death, DoR is censored at the date of last adequate tumor assessment (defined as an assessment of CR, PR, Non-CR/Non-PD, or SD)
Time frame
from enrollment until disease progression (up to 48 months)4
response rate in patients with different PIK3CA mutations
defined as the proportion of patients with different PIK3CA mutations who experienced a complete or partial response (according to RECIST v 1.1) and reported with its 95% Confidence Interval (95% CI)
Time frame
Every 8 (±1) weeks during the first 2 years, every 12 (±1) weeks therafter, from enrollment until disease progression (up to 48 months).Other outcomes
1
response rate to inavolisib in correlation with molecular characteristics of the tumour
defined as the proportion of patients who experienced a complete or partial response (according to RECIST v 1.1), reported with its 95% Confidence Interval (95% CI), with respect to the molecular characteristcs evaluated on the paraffin embedded sample from the primary surgery/biopsy (chemotherapy - naive patients).
Time frame
Every 8 (±1) weeks during the first 2 years, every 12 (±1) weeks therafter, from enrollment until disease progression (up to 48 months).2
correlation of identified mutations in tumor tissue and blood during therapy
Evaluate the correlation between mutations detected in paraffin embedded samples from the primary surgery/biopsy and tumor fraction and mutations in ctDNA.
Time frame
from enrollment until disease progression (up to 48 months).Sponsors and contacts
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Source ClinicalTrials.gov
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