Testing the Addition of Ipatasertib to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) for Stage III or IV Epithelial Ovarian Cancer
Active, enrolledPhase 1Results postedLast updated 19 December 2025
What this trial tests
Phase 1 trial testing Biopsy in Fallopian Tube Endometrioid Adenocarcinoma in 25 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, female only, with Fallopian Tube Endometrioid Adenocarcinoma or Fallopian Tube High Grade Serous Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence of Dose Limiting Toxicities (DLTs) During Dose Escalation PhasePrimary· First cycle of 21 days
The incidence of DLTs was assessed based on the number of participants who experienced at least one dose-limiting toxicity (DLT) during the Dose Escalation phase, which was used to estimate the maximum tolerated dose (MTD). A DLT was defined as any protocol-specified adverse event that was possibly, probably, or definitely related to study drug combination and occurred during the first cycle of neoadjuvant chemotherapy, unless the event was clearly unrelated to the study therapy. Adverse events were assessed and graded according to NCI CTCAE v5.0.
Group
Value
95% CI
DL1 Dose Escalation Cohort
1
DL2 Dose Escalation Cohort
2
Incidence of Dose-limiting Toxicities (DLTs) During Dose Expansion PhasePrimary· First cycle of 21 days
The incidence of DLTs was assessed based on the number of participants who experienced at least one DLT during the Dose Expansion phase. This assessment was used to evaluate the feasibility of the treatment regimen at the estimated MTD, specially dose level 1. A DLT was defined as any protocol-specified adverse effect that was possibly, probably, or definitely related to study drug combination and occurred during the first cycle of neoadjuvant chemotherapy, unless the event was clearly unrelated to study therapy. Adverse events were assessed and graded according to NCI CTCAE v.5.0.
Group
Value
95% CI
DL1 Dose Expansion Cohort
2
Incidence of Grade 3 or Higher Adverse Events (AEs)Primary· During treatment period and up to 90 days after the last dose of ipatasertib. The median duration of study treatment was 68 days with a range from 1 day to 90 days.
The incidence of grade 3 or higher AEs was assessed based on the number of participants who experienced at least one grade 3 or higher adverse event. Adverse events were graded and categorized according to NCI CTCAE v5.0.
Group
Value
95% CI
DL1 Dose Escalation Cohort
2
DL1 Dose Expansion-only Cohort
8
DL2 Dose Escalation Cohort
5
Tumor ResponseSecondary· At 3 weeks (+/- 7 days) post Cycle 3 of the study treatment and prior to IDS.
Tumor response was assessed by RECIST 1.1 at 3 weeks (+/- 7 days) post Cycle 3 of the study treatment and prior to interval debulking surgery (IDS), and it could be repeated any other time if clinically indicated based on symptoms or physical signs suggestive of new or progressive disease.
Group
Value
95% CI
DL1 Dose Escalation Cohort
0
DL1 Dose Expansion-only Cohort
1
DL2 Dose Escalation Cohort
0
DL1 Dose Escalation Cohort
3
DL1 Dose Expansion-only Cohort
5
DL2 Dose Escalation Cohort
3
DL1 Dose Escalation Cohort
1
DL1 Dose Expansion-only Cohort
2
DL2 Dose Escalation Cohort
1
DL1 Dose Escalation Cohort
2
DL1 Dose Expansion-only Cohort
3
DL2 Dose Escalation Cohort
0
Adverse events — posted to ClinicalTrials.gov
Time frame: During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
DL1 Dose Escalation Cohort
Serious: 1/7 (14%)
Deaths: 0/7
DL1 Dose Expansion-only Cohort
Serious: 3/13 (23%)
Deaths: 0/13
DL2 Dose Escalation Cohort
Serious: 5/5 (100%)
Deaths: 1/5
Serious adverse events (9 terms)
Reaction
System
DL1 Dose Escalation Cohort
DL1 Dose Expansion-only Co…
DL2 Dose Escalation Cohort
Diarrhea
Gastrointestinal disorders
—
—
—
Neutrophil Count Decreased
Investigations
—
—
—
Cardiac Arrest
Cardiac disorders
—
—
—
Death Nos
General disorders
—
—
—
Sepsis
Infections and infestations
—
—
—
Aspartate Aminotransferase Increased
Investigations
—
—
—
Syncope
Nervous system disorders
—
—
—
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
—
—
—
Thromboembolic Event
Vascular disorders
—
—
—
Other adverse events (113 terms — click to expand)
This phase I/IB trial tests the safety, side effects, and best dose of ipatasertib in combination with paclitaxel and carboplatin in treating patients with stage III or IV epithelial ovarian cancer. Ipatasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Paclitaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving ipatasertib in combination with paclitaxel and carboplatin may lower the chance of the tumor growing or spreading for longer than the paclitaxel and carboplatin alone.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT04092270 — A Study Combining the Peposertib (M3814) Pill With Standard Chemotherapy in Patients With Ovarian Cancer With an Expansi
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 19 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05276973.