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

Sponsor
National Cancer Institute, Naples
Study ID
NCT07522697
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Inavolisib — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
May 31, 2030
Completion
May 31, 2030

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Objective response rate (ORR) [ 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). ]

Central Contacts

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