Trial purpose
Cancer treatment
Tumor type
Gynaecological
Age
18+
Clinical summary
Summary
This study is recruiting people with p53 Wild-Type advanced or recurrent endometrial carcinoma who have completed a single line of platinum-based therapy and achieve confirmed partial or complete response. It is evaluating whether giving a drug called Selinexor as maintenance therapy is safe and effective compared to a placebo.
Eligible participants will be randomly allocated (by chance) to either the Experimental or Placebo Comparator arm.
In the Experimental Arm, participants will receive a fixed dose of selinexor (60mg) as an oral tablet once weekly on Days 1, 8, 15, and 22 of each 28-day cycle.
In the Placebo Comparator Arm, participants will receive matching placebo oral tablets once weekly on Days 1, 8, 15, and 22 of each 28-day cycle.
Conditions
This trial is treating patients with p53 Wild Type endometrial carcinoma
Eligibility
Inclusion
- 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.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
- You are able to swallow medication by mouth.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
- NCT05611931 *
- XPORT-EC-042; GOG-3083; ENGOT-EN20; ANZGOG2216/2023
Trial sponsor
Karyopharm Therapeutics Inc
Scientific Title
A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
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