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Trial record 1 of 1 for:    GOG 3083
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Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma (XPORT-EC-042)

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ClinicalTrials.gov Identifier: NCT05611931
Recruitment Status : Recruiting
First Posted : November 10, 2022
Last Update Posted : April 1, 2024
Sponsor:
Collaborators:
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Belgium and Luxembourg Gynaecological Oncology Group
North Eastern German Society of Gynaecological Oncology
Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies
Spanish Research Group in Ovarian Cancer
The Central and Eastern European Gynecologic Oncology Group
Israeli Society of Gynecologic Oncology
Australia New Zealand Gynaecological Oncology Group
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Drug: Selinexor Drug: Matching Placebo for selinexor Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double blind placebo-controlled study
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 18, 2023
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : January 31, 2028

Resource links provided by the National Library of Medicine

Drug Information available for: Selinexor

Arms and Interventions
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Arm Intervention/treatment
Experimental: Selinexor
Participants will receive a fixed dose of selinexor 60 milligrams (mg) oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle.
 Drug: Selinexor
Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
Other Name: KPT-330
Placebo Comparator: Placebo
Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.
 Drug: Matching Placebo for selinexor
Dose:60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) Assessed by Investigator as per RECIST v1.1 [ Time Frame: Time from randomization until disease progression (PD) or death, whichever occurs first (up to 34 months) ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 34 months ]
  2. Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs [ Time Frame: From start of study drug administration up to 34 months ]
  3. Number of Participants with Clinically Significant Changes in Clinical Laboratory Values, Vital Signs and Physical Examination Reported as an Adverse Event [ Time Frame: From start of study drug administration up to 34 months ]
  4. Number of Participants With Severity of Adverse Event According to Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0 [ Time Frame: From start of study drug administration up to 34 months ]
  5. Time to First Subsequent Therapy (TFST) [ Time Frame: Time from randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months) ]
  6. Time to Second Subsequent Therapy (TSST) [ Time Frame: Time from randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months) ]
  7. Progression-free Survival After Consecutive Treatment (PFS2) [ Time Frame: Time from randomization until the second progression event or death due to any cause, whichever occurs first (up to 34 months) ]
  8. Progression-free Survival (PFS) Assessed by a Blinded Independent Central Review (BICR), per RECIST v1.1 [ Time Frame: Time from randomization until PD or death, whichever occurs first (up to 34 months) ]
  9. European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) [ Time Frame: Baseline up to 34 months ]
    EQ-5D-5L is a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05611931


Contacts
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Contact: Karyopharm Medical Information (888) 209-9326 clinicaltrials@karyopharm.com

Locations
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Sponsors and Collaborators
Karyopharm Therapeutics Inc
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Belgium and Luxembourg Gynaecological Oncology Group
North Eastern German Society of Gynaecological Oncology
Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies
Spanish Research Group in Ovarian Cancer
The Central and Eastern European Gynecologic Oncology Group
Israeli Society of Gynecologic Oncology
Australia New Zealand Gynaecological Oncology Group
More Information
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Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT05611931    
Other Study ID Numbers: XPORT-EC-042
GOG-3083 ( Other Identifier: The GOG Foundation, Inc. )
ENGOT-EN20 ( Other Identifier: European Network of Gynaecological Oncological Trial )
First Posted: November 10, 2022    Key Record Dates
Last Update Posted: April 1, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Karyopharm Therapeutics Inc:
Selinexor
KPT-330
Advanced or Recurrent Endometrial Carcinoma
XPORT-EC
ENGOT-EN20
 GOG-3083
XPORT-EC-042
p53 wild-type
Tumor protein 53 wild-type
Additional relevant MeSH terms:
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Carcinoma
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases