Testing the Addition of Ipatasertib to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) for Stage III or IV Epithelial Ovarian Cancer
Phase I/IB Safety and Pharmacodynamic Study of Neoadjuvant (NACT) Paclitaxel and Carboplatin With Ipatasertib as Initial Therapy of Ovarian Cancer PTMA 100805
3 other identifiers
interventional
25
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2022
Typical duration for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2022
CompletedFirst Posted
Study publicly available on registry
March 14, 2022
CompletedStudy Start
First participant enrolled
September 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2025
CompletedResults Posted
Study results publicly available
December 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2026
CompletedDecember 19, 2025
October 1, 2025
2.4 years
March 11, 2022
October 10, 2025
December 9, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Incidence of Dose Limiting Toxicities (DLTs) During Dose Escalation Phase
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.
First cycle of 21 days
Incidence of Dose-limiting Toxicities (DLTs) During Dose Expansion Phase
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.
First cycle of 21 days
Incidence of Grade 3 or Higher Adverse Events (AEs)
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.
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.
Secondary Outcomes (1)
Tumor Response
At 3 weeks (+/- 7 days) post Cycle 3 of the study treatment and prior to IDS.
Other Outcomes (5)
Phosphorylated (p)PRAS40 Expression in Tumor
Up to 90 days
Measurements of Tissue and Blood Pharmacokinetics for Ipatasertib
Up to day of surgery
Tumor Response
Up to 90 days
- +2 more other outcomes
Study Arms (1)
Treatment (paclitaxel, carboplatin, ipatasertib)
EXPERIMENTALPatients receive paclitaxel IV at 175mg/m2 over 3 hours and carboplatin IV at AUC 5 over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ipatasertib PO QD until 24 hours before surgery in the absence of disease progression or unacceptable toxicity.
Interventions
Undergo biopsy
Given IV
Given PO
Given IV
Eligibility Criteria
You may qualify if:
- Pathologically proven diagnosis of ovarian cancer (ovarian cancer = fallopian tube cancer, ovarian cancer, primary peritoneal cancer). Required data element: submission of pathology report. Patients with the following histologic cell types are eligible:
- High grade serous
- Endometrioid adenocarcinoma, grade 3 Genomic/genetic testing results will be a data collection element if performed as part of usual care (germline genetic testing, tumor genomic testing, homologous recombination deficiency \[HRD\] testing). Genetic/genomic testing results should be uploaded if they become available anytime during conduct of the study
- Appropriate stage for study entry defined as stage III or stage IV based on the following diagnostic workup:
- History/physical examination within 14 days prior to registration
- Imaging with computed tomography (CT) chest/abdomen/pelvis (C/A/P) within 28 days prior to registration
- Patients must have evaluable disease or measurable disease defined by RECIST version (v) 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be \>= 10 mm when measured by CT or magnetic resonance imaging (MRI). Lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI
- Pre-treatment formalin-fixed, paraffin-embedded (FFPE) tumor block collected from laparoscopy (preferred) or five 18G cores by radiology/interventional radiology (acceptable) must be available for submission
- Disease must be considered unresectable via primary debulking surgery and in need of neoadjuvant chemotherapy (NACT) prior to debulking surgery. This assessment of unresectability can be made via imaging or laparoscopic scoring
- No prior therapy directed at ovarian cancer
- Age \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 within 14 days prior to registration
- Absolute neutrophil count \>= 1,000/mcl (within 14 days prior to registration)
- Platelets \>= 100,000/mcl (within 14 days prior to registration)
- Creatinine =\< institutional/laboratory upper limit of normal (ULN) or creatinine clearance (CrCL) or estimated glomerular filtration rate (eGFR) of \>= 60 mL/min estimated using either the Cockcroft-Gault equation, the Modification of Diet in Renal Disease Study, or as reported in the comprehensive metabolic panel/basic metabolic panel (eGFR) (within 14 days prior to registration)
- +10 more criteria
You may not qualify if:
- Prior treatment with agent(s) targeting PI3K/AKT/mTor pathway
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ipatasertib, paclitaxel or carboplatin
- Currently receiving any other investigational agents or has received an investigational agent within 4 weeks of study registration
- Abnormal gastrointestinal function. This includes gastrointestinal (GI) obstruction or bleeding or signs/symptoms thereof within 3 months of study registration
- Patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula
- Received prior radiotherapy to any portion of the abdominal cavity or pelvis
- Patients with uncontrolled intercurrent illness
- Patients with psychiatric illness/social situations that would limit compliance with study requirements
- Patients with active infections requiring intravenous antibiotics
- Patients with diabetes either requiring insulin therapy or with a baseline fasting glucose \>= 160 mg/dL and/or high glycosylated hemoglobin (HbA1c) (\> 8), suggesting poorly controlled diabetes. Fasting is defined as abstaining from food and drink (with the exception of water) for at least 8 hours
- Patients with grade \>= 2 uncontrolled or untreated hypercholesterolemia (\> 300 mg/dL) or hypertriglyceridemia (\> 300 mg/dL) would be an ineligible
- History of or active inflammatory bowel disease (e.g., Crohn's disease and/or ulcerative colitis) or active bowel inflammation (e.g., diverticulitis)
- Lung disease: Pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia)
- Patients with known brain metastases or leptomeningeal disease are not eligible, as prior treatment directed at ovarian cancer is not allowed
- Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to registration
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- NRG Oncologycollaborator
Study Sites (8)
UCSF Medical Center-Mission Bay
San Francisco, California, 94158, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Helen Huang on behalf of Wei Deng, PhD.
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine C Fuh
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2022
First Posted
March 14, 2022
Study Start
September 8, 2022
Primary Completion
January 30, 2025
Study Completion
February 26, 2026
Last Updated
December 19, 2025
Results First Posted
December 19, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.