Ovarian Cancer Clinical Trial

Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

Summary

The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks of platinum-based therapy. A total of 220 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

At least 18 years of age at the time of signing informed consent.
Histologically confirmed EC including: endometrioid, serous, undifferentiated, and carcinosarcoma.
TP53 wt assessed by next generation sequencing (NGS), evaluated by a central vendor.
Completed a single line, at least 12 weeks of platinum-based therapy (not including adjuvant or neoadjuvant therapy for Stage I-III disease) and achieved confirmed partial or complete response (PR or CR) by imaging, according to RECIST version 1.1. The participants should have received treatment for:

Primary Stage IV disease, defined as:

had a primary or later debulking surgery during first-line platinum-based therapy with R0 resection (R0 resection indicates a macroscopic complete resection of all visible tumor) and achieved CR after at least 12 weeks platinum-based therapy, OR
had a primary or later debulking surgery during first-line platinum-based therapy with R1 resection (R1 resection indicates incomplete removal of all macroscopic disease) and achieved PR or CR after at least 12 weeks platinum-based chemotherapy, OR
had no surgery and achieved PR or CR after at least 12 weeks platinum-based chemotherapy

OR

At first relapse (i.e., relapse after primary therapy including surgery and/or chemotherapy and/or immunotherapy for Stage I-IV disease), defined as:

had Stage I - III disease at diagnosis and received, at initial diagnosis, adjuvant chemotherapy and relapsed later. Participants should have PR or CR after at least 12 weeks of platinum-based chemotherapy compared with the start of this chemotherapy at the time of relapse,
had Stage I-III disease at diagnosis and did not receive adjuvant chemotherapy at initial diagnosis and relapsed later. Participants should have PR or CR after at least 12 weeks of platinum-based chemotherapy compared with the start of this chemotherapy at the time of relapse, OR

had Stage IV disease at diagnosis and received initially chemotherapy with or without surgery and relapsed later. At the time of relapse, participants should have PR or CR after at least 12 weeks of platinum-based chemotherapy compared with the start of this chemotherapy at the time of relapse.

Previous treatment with anti-programmed cell death protein 1(PD-1) or anti-programmed death-ligand 1(PD-L1) monoclonal antibody and concomitant biologic agents (e.g., bevacizumab, trastuzumab) is allowed.
Must be able to initiate study drug 3 to 8 weeks after completion of their final dose of chemotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Participants must have adequate bone marrow function and organ function within 2 weeks before starting study drug as defined by the following laboratory criteria:
Hepatic function: total bilirubin up to less than (<) 3*upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to (<=) 2.5*ULN in participants without liver metastasis. For participants with known liver involvement of their tumor: AST and ALT (<=) 5*ULN
Hematopoietic function within 1 week: Absolute neutrophil count (ANC) greater than or equal to (>=) 1.5*10^9/liter (L); platelet count >= 100*10^9/L; hemoglobin >= 9.0 gram per deciliter (g/dL) per local laboratory results

Renal function: estimated creatinine clearance (CrCl) of >= 20 milliliter per minute (mL/min), calculated using the standard local formula, as applicable

- In the opinion of the Investigator, the participant must:

Have a life expectancy of at least 12 weeks, and

Be fit to receive investigational therapy

Premenopausal females of childbearing potential must have a negative pregnancy test (serum β-human chorionic gonadotropin test) prior to the first dose of study drug. Female participants of childbearing potential must agree to use highly effective methods of contraception throughout the study and for 90 days following the last dose of study drug.
Written informed consent signed in accordance with federal, local, and institutional guidelines prior to the first screening procedure.

Exclusion Criteria:

Participants meeting any of the following exclusion criteria are not eligible to enroll in this study:
Has any uterine sarcomas (carcinosarcomas - not excluded), clear cell or small cell carcinoma with neuroendocrine differentiation
Received a blood or platelet transfusion during the 2 weeks prior to Cycle 1 Day 1 (C1D1). Participants' hemoglobin must be assessed within 2 weeks of screening and at least 1 week post transfusion
Concurrent systemic steroid therapy higher than physiologic dose (> 10 milligram per day [mg/day] of prednisone or equivalent). Systemic steroid therapy as pre-medication for taxane is allowed

Insufficient time since or not recovered from procedures or anti-cancer therapy, defined as:

Not recovered from major surgery <= 28 days prior to Day 1 dosing. Minor procedures, such as biopsies, dental work, or placement of a port or intravenous (IV) line for infusion are permitted
Having ongoing clinically significant anti-cancer therapy-related toxicities CTCAE Grade > 1, with the exception of alopecia. In specific cases, participants whose toxicity has stabilized or with Grade 2 non-hematologic toxicities can be allowed following documented approval by the Sponsor's Medical Monitor
Palliative radiotherapy within 14 days of the intended C1D1. Palliative radiotherapy may be permitted for symptomatic control of pain from bone metastases, provided that the radiotherapy does not involve target lesions, and the reason for the radiotherapy does not reflect evidence of disease progression.
Any gastrointestinal dysfunctions that could interfere with the absorption of selinexor (e.g., bowel obstruction, inability to swallow tablets, malabsorption syndrome, unresolved nausea, vomiting, diarrhea CTCAE v 5.0 > grade 1).
Participants unable to tolerate two forms of antiemetics for at least 2 cycles will not be eligible for the trial.
Active, ongoing or uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week of screening.
Serious psychiatric or medical condition that could interfere with participation in the study or in the opinion of the Investigator would make study involvement unreasonably hazardous.
Previous treatment with an XPO1 inhibitor.
Stable disease or PD on the post-chemotherapy scan or clinical evidence of progression prior to randomization.
Participants who received any systemic anticancer therapy including investigational agents <= 3 weeks (or <= 5 half-lives of the drug [whichever is shorter]) prior to C1D1.
Major injuries or surgery within 14 days prior to C1D1 and/or planned major surgery during the on-treatment study period.
Other malignant disease with disease-free <= 3 years except: curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or ductal carcinoma in situ (DCIS) of the breast.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to selinexor, or other agents used in the study.
Active brain metastases (e.g., stable for < 8 weeks, no adequate previous treatment with radiotherapy and/or surgery, symptomatic, requiring treatment with anti-convulsant therapy. Corticoid therapy is allowed if administered as stable dose for at least 1 month before randomization).
Females who are pregnant or lactating.
Any other life-threatening illness, active medical condition, organ system dysfunction, or serious active psychiatric issue which, in the Investigator's opinion, could compromise the participant's safety or the participant's ability to remain compliant with study procedures.

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

220

Study ID:

NCT05611931

Recruitment Status:

Recruiting

Sponsor:

Karyopharm Therapeutics Inc

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There are 25 Locations for this study

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Honor Health
Phoenix Arizona, 85016, United States More Info
Mei Yu
Contact
[email protected]
Bradley Monk
Principal Investigator
Mount Sinai Comprehensive Cancer Center
Miami Beach Florida, 33140, United States More Info
Krystal Olivera
Contact
305-674-2625
[email protected]
Brian Slomovitz
Principal Investigator
Illinois Cancer Specialists
Arlington Heights Illinois, 60005, United States More Info
Laura Lozano
Contact
[email protected]
Urszula Sobol
Principal Investigator
St Vincent Hospital
Indianapolis Indiana, 46260, United States More Info
Cynthia Cruz Rivera
Contact
317-415-6747
[email protected]
Michael Callahan
Principal Investigator
Our Lady of the Lake Hospital, Inc.
Baton Rouge Louisiana, 70808, United States More Info
Tammy Hines
Contact
225-924-8394
[email protected]
Sobia Ozair
Principal Investigator
Trials365, LLC
Shreveport Louisiana, 71133, United States More Info
Carrie Kay
Contact
318-408-1198
[email protected]
Destin Black
Principal Investigator
St. Dominic's Gynecologic Oncology
Jackson Mississippi, 39216, United States More Info
Khadijra Lockwood
Contact
601-200-4479
[email protected]
Christen Haygood
Principal Investigator
Midwest Ventures Group HCA Mid America Division
Kansas City Missouri, 64132, United States More Info
Megan Werner
Contact
[email protected]
Kristopher (Shawn) LyBarger
Principal Investigator
Center Of Hope
Reno Nevada, 89511, United States More Info
Shannon Pierpoint
Contact
775-327-4673
[email protected]
Peter Lim
Principal Investigator
Women's Cancer Care Associates, LLC
Albany New York, 12208, United States More Info
Nicolina Suriano
Contact
518-458-1390
[email protected]
Joyce Barlin
Principal Investigator
NYU Langone Hospital-Long Island
Mineola New York, 11501, United States More Info
Karen Estok
Contact
212-404-4434
[email protected]
Bhavana Pothuri
Principal Investigator
Perlmutter Cancer Center at NYU Langone Health
New York New York, 10016, United States More Info
Keith Kallas
Contact
929-455-2433
[email protected]
Bhavana Pothuri
Principal Investigator
Chattanooga's Program in Women's Oncology
Chattanooga Tennessee, 37403, United States More Info
Kimberly Donelson
Contact
423-266-3636
[email protected]
Stephen DePasquale
Principal Investigator
University of Tennessee Medical Center
Knoxville Tennessee, 37920, United States More Info
Krissy Bolig
Contact
865-305-7469
[email protected]
Larry Kilgore
Principal Investigator
Texas Oncology - Dallas
Dallas Texas, 75246, United States More Info
Dominique Marquez
Contact
[email protected]
Brandon Sawyer
Principal Investigator
Texas Oncology - Fort Worth
Fort Worth Texas, 76104, United States More Info
Nori Sullivan
Contact
[email protected]
Noelle Cloven
Principal Investigator
Texas Oncology - The Woodlands
The Woodlands Texas, 77380, United States More Info
Taryn Davis
Contact
[email protected]
Christine Lee
Principal Investigator
University of Wisconsin Hospital and Clinics
Madison Wisconsin, 53792, United States More Info
Claire Kostechka
Contact
608-263-0796
[email protected]
Ellen Hartenbach
Principal Investigator
Hillel-Yaffe Medical Center
Hadera , 38100, Israel More Info
Kasanesh Redai
Contact
+972-52-4397690
[email protected]
Ilan Bruchim
Principal Investigator
Wolfson Medical Center
Holon , , Israel More Info
Gali Borntnik
Contact
+972-52-2358460
[email protected]
Tally Levy
Principal Investigator
Hadassah Medical Center
Jerusalem , 91120, Israel More Info
Rivka Ashlem
Contact
+972-50-9888604
[email protected]
Aviad Zick
Principal Investigator
Sheba Medical Center
Ramat Gan , 52621, Israel More Info
Revital Levit
Contact
[email protected]
Limor Helpman
Principal Investigator
Hospital Universitario Donostia
Gipuzkoa , 20014, Spain More Info
Maria Hidalgo
Contact
003434 943 328151
[email protected]
Cristina Churruca
Principal Investigator
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain More Info
Maria Canton
Contact
[email protected]
Eva Maria Guerra
Principal Investigator
Hospital Universitario Virgen del Rocío
Sevilla , 41013, Spain More Info
Laura Bernal
Contact
0034955013068
[email protected]
Purificacion Estevez Garcia
Principal Investigator
Hospital LaFe Uacenlia
Valencia , 46026, Spain More Info
Marian Lavin
Contact
[email protected]
Helena De la Cueva
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

220

Study ID:

NCT05611931

Recruitment Status:

Recruiting

Sponsor:


Karyopharm Therapeutics Inc

How clear is this clinincal trial information?

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