DRUG
Ipatasertib
Ipatasertib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 28 days)
Status
Active, not recruiting
Phase
Phase 2
Enrollment
176
Locations
41
Results
Not posted
Publications
1
Study summary
This study will evaluate the efficacy and safety of multiple biomarker-selected treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase.
Interventions
DRUG
Ipatasertib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 28 days)
DRUG
Cobimetinib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length=28 days)
DRUG
Trastuzumab Emtansine will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
DRUG
Atezolizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
DRUG
Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
DRUG
Paclitaxel will be administered intravenously on Days 1, 8, and 15 of each cycle. (Cycle length=28 days)
DRUG
Giredestrant will be administered by mouth once a day on Days 1-28 of each cycle (Cycle length=28 days)
DRUG
Abemaciclib will be administered by mouth twice a day during each 28-day cycle
DRUG
Inavolisib will be administered by mouth once a day on Days 1-28 of each 28-day cycle
DRUG
Palbociclib will be administered by mouth once a day on Days 1-21 of each 28-day cycle
DRUG
Letrozole will be administered by mouth once a day on Days 1-28 of each 28-day cycle
DRUG
Olaparib will be administered by mouth twice a day on Days 1-28 of each 28-day cycle
Timeline
First posted
Jun 18, 2021
Study start
Oct 7, 2021
Primary completion
Feb 28, 2028
Study completion
May 30, 2028
Results posted
Not reported
Registry updated
Jun 8, 2026
Outcomes
Confirmed Objective Response Rate (ORR)
Time frame · Up to approximately 5 years
Confirmed ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) (demonstrated on two consecutive occasions \>=4 weeks apart), as determined by the investigator according to RECIST v1.1.
Duration of Response (DOR)
Time frame · Up to approximately 5 years
DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
Disease Contral Rate (DCR)
Time frame · Up to approximately 5 years
DCR is defined as the proportion of participants with a confirmed CR or PR, or stable disease maintained for at least 16 weeks, as determined by the investigator according to RECIST v1.1.
Progression Free Survival (PFS)
Time frame · Up to approximately 5 years
PFS after start of treatment is defined as the time from start of treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
6-Month PFS Rate
Time frame · Up to 6 month
6-month PFS rate is defined as the proportion of participants who remained alive and progression-free at 6 months after start of treatment, as determined by the investigator according to RECIST v1.1.
Overall Survival (OS)
Time frame · Up to approximately 5 years
OS after start of treatment is defined as the time from start of treatment to death from any cause.
Confirmed ORR as Determined by IRC (Independent Review Committee)
Time frame · Up to approximately 5 years
Confirmed ORR, as determined by the IRC according to RECIST v1.1.
DOR as Determined by IRC
Time frame · Up to approximately 5 years
DOR, as determined by the IRC according to RECIST v1.1
DCR as Determined by IRC
Time frame · Up to approximately 5 years
DCR, as determined by the IRC according to RECIST v1.1
PFS as Determined by IRC
Time frame · Up to approximately 5 years
PFS, as determined by the IRC according to RECIST v1.1
Percentage of Participants With Adverse Events
Time frame · Up to approximately 5 years
Percentage of participants with adverse events.
Eligibility
Inclusion Criteria: * Persistent or recurrent EOC that meets the following criteria: Histologically confirmed non-high-grade serous, non-high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer, including but not limited to low-grade serous ovarian carcinoma, clear cell carcinoma, mucinous carcinoma, carcinosarcoma, undifferentiated carcinoma, seromucinous carcinoma, malignant Brenner tumors, Grades 1 or 2 endometrioid carcinoma, mesonephric-like adenocarcinoma and small cell carcinoma of the ovary, hypercalcemic type (SCCOHT). Disease that is not amenable to curative surgery * Measurable disease (at least one target lesion) according to RECIST v1.1 * Previous treatment with one to four lines of therapy, at least one of which was platinum-based. Hormonal therapy does not count as a line of therapy. * Platinum-resistant disease, defined as disease progression during or within 6 months of last platinum therapy, with the following exception: Participants with primary platinum-refractory disease are excluded. * Submission of a representative tumor specimen that is suitable for next-generation sequencing (NGS) testing and estrogen receptor immunohistochemistry (ER IHC) to determine treatment arm assignment and for central pathology review. * Submission of the local pathology report and, if available, any associated stained slides that supported the local diagnosis of the histology (to be used for central pathology review) * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Adequate hematologic and end-organ function * For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs (if applicable) * In addition to the general inclusion criteria above, participants must meet all of the arm-specific inclusion criteria for the respective arm General Exclusion Criteria: * Pregnant or breastfeeding, or intending to become pregnant or breastfeed during the study * Primary platinum-refractory disease, defined as progression during or within 4 weeks after the last dose of the first-line platinum treatment * Histologic diagnosis of high-grade serous or high-grade endometrioid ovarian, fallopian tube, or primary peritoneal cancer * Current diagnosis of solely borderline epithelial ovarian tumor * Current diagnosis of non-epithelial ovarian tumors * Current diagnosis of synchronous primary endometrial cancer * Prior history of primary endometrial cancer, with the following exception: a prior diagnosis of primary endometrial cancer is permitted if it meets all of the following conditions: Stage IA, no lymphovascular invasion, International Federation of Gynecology and Obstetrics Grade 1 or 2, not a high-grade subtype. * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * Symptomatic, untreated, or actively progressing CNS metastases * Severe infection within 4 weeks prior to initiation of study treatment * Treatment with chemotherapy, radiotherapy, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, or investigational therapy within 28 days prior to initiation of study treatment * Treatment with hormonal therapy within 14 days prior to initiation of study treatment * In addition to the general exclusion criteria above, participants can not meet any of the arm-specific exclusion criteria for the respective arm
Study locations
Australia · Canada · Czechia · France · Germany · Italy · Russia · South Korea · Spain · Switzerland · Turkey (Türkiye) · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
UCSF Helen Diller Family CCC
San Francisco, California, United States
Washington University School of Medicine
St Louis, Missouri, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Texas Oncology - Gulf Coast
The Woodlands, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, United States
Cabrini Hospital
Malvern, Victoria, Australia
Princess Margaret Cancer Center
Toronto, Ontario, Canada
McGill University Health Centre - Glen Site
Montreal, Quebec, Canada
Gynekologicko-porodnicka klinika
Prague, Czechia
CHU Besançon - Hôpital Jean Minjoz
Besançon, France
Centre Francois Baclesse
Caen, France
Centre Leon Berard
Lyon, France
Groupe Hospitalier Diaconesses
Paris, France
Centre Eugène Marquis
Rennes, France
ICO - Site René Gauducheau
Saint-Herblain, France
Institut Claudius Regaud
Toulouse, France
Gustave Roussy
Villejuif, France
Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie
Essen, Germany
Universitätsklinikum Mannheim
Mannheim, Germany
A.O. U. Consorziale Policlinico di Bari
Bari, Apulia, Italy
Istituto Tumori Napoli
Naples, Campania, Italy
Publications
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