Not Yet RecruitingPhase 2

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

Italy48 participantsStarted 2026-05

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Is not a Women of Childbearing Potential (WOCBP) A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis).
✓. Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the intervention period and for at least 1 weeks after the final dose of inavolisib. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
✓. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) within 24 hours before the first dose of study intervention.

Exclusion criteria

✕. Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible
✕. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.

What they're measuring

Objective response rate (ORR)

Timeframe: Every 8 (±1) weeks during the first 2 years, every 12 (±1) weeks therafter, from enrollment until disease progression (up to 48 months).

Trial details

NCT IDNCT07522697

SponsorNational Cancer Institute, Naples

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-05

Contact for this trial

Maria Lucia Iacovino

+39 08117770692 marialucia.iacovino@istitutotumori.na.it

View on ClinicalTrials.gov More Endometrial Cancer trials