- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05276973
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
Study Overview
Status
Conditions
- Ovarian Endometrioid Adenocarcinoma
- Primary Peritoneal High Grade Serous Adenocarcinoma
- Fallopian Tube Endometrioid Adenocarcinoma
- Ovarian High Grade Serous Adenocarcinoma
- Fallopian Tube High Grade Serous Adenocarcinoma
- Primary Peritoneal Endometrioid Adenocarcinoma
- Stage III Fallopian Tube Cancer AJCC v8
- Stage III Ovarian Cancer AJCC v8
- Stage III Primary Peritoneal Cancer AJCC v8
- Stage IV Fallopian Tube Cancer AJCC v8
- Stage IV Ovarian Cancer AJCC v8
- Stage IV Primary Peritoneal Cancer AJCC v8
- Unresectable Fallopian Tube Endometrioid Adenocarcinoma
- Unresectable Fallopian Tube High Grade Serous Adenocarcinoma
- Unresectable Ovarian Endometrioid Adenocarcinoma
- Unresectable Ovarian High Grade Serous Adenocarcinoma
- Unresectable Primary Peritoneal Endometrioid Adenocarcinoma
- Unresectable Primary Peritoneal High Grade Serous Adenocarcinoma
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To estimate the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of ipatasertib in combination with paclitaxel and carboplatin as neoadjuvant chemotherapy for ovarian cancer.
II. To determine the feasibility of the treatment regimen once the MTD is estimated.
III. To assess the toxicities of ipatasertib in combination with paclitaxel and carboplatin by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
SECONDARY OBJECTIVE:
I. Objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 prior to interval debulking surgery (IDS).
TRANSLATIONAL RESEARCH OBJECTIVES:
I. To evaluate the change of phosphorylated (p)PRAS40 expression in the pre-treatment tumor versus (vs.) on-treatment tumor.
II. To identify the pharmacokinetics of ipatasertib in the tissue and blood. III. To correlate antitumor response with genomic alterations in PI3K pathway genes (PTEN, PIK3CA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1).
IV. To correlate antitumor response with transcriptomic alterations in PI3K pathway genes (PTEN, PIK3CA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1).
V. To correlate response with PTEN loss.
OUTLINE: This is a dose-escalation study of ipatasertib followed by a dose-expansion study.
Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV 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 orally (PO) once daily (QD) until 24 hours before surgery in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 and 90 days.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94158
- Recruiting
- UCSF Medical Center-Mission Bay
-
Contact:
- Site Public Contact
- Phone Number: 877-827-3222
- Email: cancertrials@ucsf.edu
-
Principal Investigator:
- Katherine C. Fuh
-
-
Georgia
-
Augusta, Georgia, United States, 30912
- Recruiting
- Augusta University Medical Center
-
Principal Investigator:
- Sharad A. Ghamande
-
Contact:
- Site Public Contact
- Phone Number: 706-721-2388
- Email: ga_cares@augusta.edu
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic Foundation
-
Contact:
- Site Public Contact
- Phone Number: 866-223-8100
- Email: TaussigResearch@ccf.org
-
Principal Investigator:
- Peter G. Rose
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- University of Oklahoma Health Sciences Center
-
Contact:
- Site Public Contact
- Phone Number: 405-271-8777
- Email: ou-clinical-trials@ouhsc.edu
-
Principal Investigator:
- Lauren E. Dockery
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19111
- Recruiting
- Fox Chase Cancer Center
-
Principal Investigator:
- Gina M. Mantia Smaldone
-
Contact:
- Site Public Contact
- Phone Number: 215-728-4790
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02905
- Recruiting
- Women and Infants Hospital
-
Contact:
- Site Public Contact
- Phone Number: 401-274-1122
-
Principal Investigator:
- Cara A. Mathews
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonwealth University/Massey Cancer Center
-
Contact:
- Site Public Contact
- Email: CTOclinops@vcu.edu
-
Principal Investigator:
- Leslie M. Randall
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Medical College of Wisconsin
-
Contact:
- Site Public Contact
- Phone Number: 414-805-3666
-
Principal Investigator:
- William H. Bradley
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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)
- Total bilirubin =< 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level =< 3 x ULN may be enrolled) (within 14 days prior to registration)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x ULN (within 14 days prior to registration)
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
- Women of childbearing potential (WOCBP) must agree to use two forms of birth control (hormonal or barrier method of birth control; abstinence) agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 28 days after the last dose of ipatasertib and agreement to refrain from donating eggs during this same period
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
- Ability to understand and willingness to sign an institutional review board (IRB) approved written informed consent document (or that of legally authorized representative, if applicable)
Exclusion Criteria:
- 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
- Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
- Known clinically significant history of liver disease consistent with Child Pugh class B or C, including active viral or other hepatitis, current drug or alcohol abuse, or cirrhosis
- Pregnant women are excluded from this study because ipatasertib is an oral AKT inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ipatasertib, breastfeeding should be discontinued if the mother is treated with ipatasertib. These potential risks may also apply to other agents used in this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (paclitaxel, carboplatin, ipatasertib)
Patients receive paclitaxel IV over 3 hours and carboplatin IV 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.
|
Given IV
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Undergo biopsy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of dose limiting toxicities (dose escalation phase)
Time Frame: Within the first cycle of neoadjuvant chemotherapy (1 cycle = 21 days)
|
The number of patients with dose limiting toxicities will be summarized by dose level.
|
Within the first cycle of neoadjuvant chemotherapy (1 cycle = 21 days)
|
Incidence of dose limiting toxicities (dose expansion phase)
Time Frame: Within the first cycle of neoadjuvant chemotherapy (1 cycle = 21 days)
|
Within the first cycle of neoadjuvant chemotherapy (1 cycle = 21 days)
|
|
Incidence of adverse events
Time Frame: Up to 90 days after last dose of study drug
|
Frequency and severity of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5 will be tabulated as descriptive statistics.
|
Up to 90 days after last dose of study drug
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor response
Time Frame: Up to day of surgery
|
Tumor response is assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and will be summarized by dose level.
The proportion of patients with objective tumor response will be estimated with their corresponding 90% confidence interval for expansion phase.
|
Up to day of surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phosphorylated (p)PRAS40 expression in tumor
Time Frame: Up to 90 days
|
Will be summarized by collection time point and dose level.
Wilcoxon signed rank test will be used to explore the change of pPRAS40 expression in the pre-treatment versus on-treatment tumor in the patients who have been treated at the maximum tolerated dose and have evaluable biopsy specimen.
|
Up to 90 days
|
Measurements of tissue and blood pharmacokinetics for ipatasertib
Time Frame: Up to day of surgery
|
Descriptive statistics (e.g., mean, standard deviation) will be given for the ipatasertib pharmacokinetics measured in the tissue and blood.
Graphs and non-linear model techniques will be used to describe and identify the maximum plasma concentration (Cmax) and the time to observed Cmax (Tmax) for ipatasertib whenever these are applied.
|
Up to day of surgery
|
Tumor response
Time Frame: Up to 90 days
|
Assessed by RECIST 1.1, and measurements for genomic alterations in PI3K Pathway genes (PTEN, PI3KCA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1).
Summary statistics (or graphs) for PTEN loss, genomic alterations in PI3K pathway genes (PTEN, PI3KCA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1), transcriptomic alterations in PI3K Pathway genes (PTEN, PI3KCA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1) will be given.
The association of objective tumor response with each of these biomarkers will be explored by appropriate statistical methods, e.g., Spearman's rank correlation coefficient for ordinal or interval type of biomarker data, chi-squared test for nominal type of biomarker data.
|
Up to 90 days
|
Tumor response
Time Frame: Up to 90 days
|
Assessed by RECIST 1.1, and measurements for transcriptomic alterations in PI3K Pathway genes (PTEN, PI3KCA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1).
Summary statistics (or graphs) for PTEN loss, genomic alterations in PI3K pathway genes (PTEN, PI3KCA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1), transcriptomic alterations in PI3K Pathway genes (PTEN, PI3KCA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1) will be given.
The association of objective tumor response with each of these biomarkers will be explored by appropriate statistical methods, e.g., Spearman's rank correlation coefficient for ordinal or interval type of biomarker data, chi-squared test for nominal type of biomarker data.
|
Up to 90 days
|
Tumor response
Time Frame: Up to 90 days
|
Assessed by RECIST 1.1, and measurement for PTEN loss.
Summary statistics (or graphs) for PTEN loss, genomic alterations in PI3K pathway genes (PTEN, PI3KCA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1), transcriptomic alterations in PI3K Pathway genes (PTEN, PI3KCA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1) will be given.
The association of objective tumor response with each of these biomarkers will be explored by appropriate statistical methods, e.g., Spearman's rank correlation coefficient for ordinal or interval type of biomarker data, chi-squared test for nominal type of biomarker data.
|
Up to 90 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Katherine C Fuh, NRG Oncology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Peritoneal Diseases
- Uterine Neoplasms
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Abdominal Neoplasms
- Cystadenocarcinoma
- Neoplasms, Cystic, Mucinous, and Serous
- Endometrial Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Adenocarcinoma
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Carcinoma, Ovarian Epithelial
- Cystadenocarcinoma, Serous
- Carcinoma, Endometrioid
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Protein Kinase Inhibitors
- Carboplatin
- Paclitaxel
- Albumin-Bound Paclitaxel
- Ipatasertib
Other Study ID Numbers
- NCI-2022-01930 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA180868 (U.S. NIH Grant/Contract)
- NRG-GY027 (Other Identifier: CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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