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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05611931


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT05611931
Ethics application status
Date submitted
3/11/2022
Date registered
10/11/2022
Date last updated
19/09/2024

Titles & IDs
Public title
Selinexor in Maintenance Therapy After Systemic Therapy for Participants with P53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
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
Secondary ID [1] 0 0
GOG-3083
Secondary ID [2] 0 0
XPORT-EC-042
Universal Trial Number (UTN)
Trial acronym
XPORT-EC-042
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Selinexor
Treatment: Drugs - Matching Placebo for selinexor

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.

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.


Treatment: Drugs: Selinexor
Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral

Treatment: Drugs: Matching Placebo for selinexor
Dose:60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) Assessed by Investigator as per RECIST v1.1
Timepoint [1] 0 0
Time from randomization until disease progression (PD) or death, whichever occurs first (up to 34 months)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 34 months
Secondary outcome [2] 0 0
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Timepoint [2] 0 0
From start of study drug administration up to 34 months
Secondary outcome [3] 0 0
Number of Participants with Clinically Significant Changes in Clinical Laboratory Values, Vital Signs and Physical Examination Reported as an Adverse Event
Timepoint [3] 0 0
From start of study drug administration up to 34 months
Secondary outcome [4] 0 0
Number of Participants With Severity of Adverse Event According to Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0
Timepoint [4] 0 0
From start of study drug administration up to 34 months
Secondary outcome [5] 0 0
Time to First Subsequent Therapy (TFST)
Timepoint [5] 0 0
Time from randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months)
Secondary outcome [6] 0 0
Time to Second Subsequent Therapy (TSST)
Timepoint [6] 0 0
Time from randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months)
Secondary outcome [7] 0 0
Progression-free Survival After Consecutive Treatment (PFS2)
Timepoint [7] 0 0
Time from randomization until the second progression event or death due to any cause, whichever occurs first (up to 34 months)
Secondary outcome [8] 0 0
Progression-free Survival (PFS) Assessed by a Blinded Independent Central Review (BICR), per RECIST v1.1
Timepoint [8] 0 0
Time from randomization until PD or death, whichever occurs first (up to 34 months)
Secondary outcome [9] 0 0
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Timepoint [9] 0 0
Baseline up to 34 months

Eligibility
Key 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 ß-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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2028
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Border Medical Oncology and Haematology - Albury East
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
Central Coast LHD - Gosford & Wyong Hospitals - Gosford
Recruitment hospital [4] 0 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [5] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [6] 0 0
Westmead Hospital - Wentworthville
Recruitment hospital [7] 0 0
ICON Cancer Centre Southport - Southport
Recruitment hospital [8] 0 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [9] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [10] 0 0
Box Hill Hospital - Eastern Health (Oncology) - Box Hill
Recruitment hospital [11] 0 0
Monash Health - Clayton
Recruitment hospital [12] 0 0
Frankston Hospital - Frankston
Recruitment hospital [13] 0 0
Cabrini Health - Malvern
Recruitment hospital [14] 0 0
Peter MacCallum Cancer Centre/RWH/RMH - Melbourne
Recruitment hospital [15] 0 0
The Royal Adelaide Hospital - Southport
Recruitment postcode(s) [1] 0 0
2640 - Albury East
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [5] 0 0
- Saint Leonards
Recruitment postcode(s) [6] 0 0
2145 - Wentworthville
Recruitment postcode(s) [7] 0 0
4215 - Southport
Recruitment postcode(s) [8] 0 0
4350 - Toowoomba
Recruitment postcode(s) [9] 0 0
7000 - Hobart
Recruitment postcode(s) [10] 0 0
3128 - Box Hill
Recruitment postcode(s) [11] 0 0
3168 - Clayton
Recruitment postcode(s) [12] 0 0
3199 - Frankston
Recruitment postcode(s) [13] 0 0
3144 - Malvern
Recruitment postcode(s) [14] 0 0
3000 - Melbourne
Recruitment postcode(s) [15] 0 0
5000 - Southport
Recruitment outside Australia
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Padova
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Pisa
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Prato
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Roma
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Sevilla
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Valencia
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Zaragoza

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Karyopharm Therapeutics Inc
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
GOG Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Belgium and Luxembourg Gynaecological Oncology Group
Address [3] 0 0
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Other
Name [4] 0 0
North Eastern German Society of Gynaecological Oncology
Address [4] 0 0
Country [4] 0 0
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Other
Name [5] 0 0
Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies
Address [5] 0 0
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Other
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Spanish Research Group in Ovarian Cancer
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The Central and Eastern European Gynecologic Oncology Group
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Israeli Society of Gynecologic Oncology
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Other
Name [9] 0 0
Australia New Zealand Gynaecological Oncology Group
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Country [9] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05611931
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Karyopharm Medical Information
Address 0 0
Country 0 0
Phone 0 0
(888) 209-9326
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05611931

Additional trial details provided through ANZCTR
Accrual to date
Recruitment state(s)
Funding & Sponsors
Primary sponsor
Commercial sector/Industry
Primary sponsor name
Karyopharm Therapeutics
Primary sponsor address
85 Wells Avenue, Suite 210, Newton, MA 02459, USA
Primary sponsor country
United States of America
Secondary sponsor category [1] 86
Other Collaborative groups
Name [1] 86
Australian New Zealand Genealogical Oncology Group
Address [1] 86
Level 6, Lifehouse, 119-143 Missenden Road, Camperdown NSW 2050
Country [1] 86
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 67
Monash Health HREC
Address [1] 67
Research Support Services Monash Health Level 2, I Block Monash Medical Centre 246 Clayton Road Clayton Victoria 3168
Country [1] 67
Australia
Date submitted for ethics approval [1] 67
22/08/2023
Approval date [1] 67
13/10/2023
Ethics approval number [1] 67
 
Public notes

Contacts
Principal investigator
Title 397 0
Dr
Name 397 0
Kate Webber
Address 397 0
Country 397 0
Australia
Phone 397 0
Fax 397 0
Email 397 0
Contact person for public queries
Title 398 0
Mr
Name 398 0
John Andrews
Address 398 0
Level 6, Lifehouse, 119-143 Missenden Road, Camperdown NSW 2050
Country 398 0
Australia
Phone 398 0
+61 2 8071 4881
Fax 398 0
Email 398 0
[email protected]
Contact person for scientific queries
Title 399 0
Mr
Name 399 0
John Andrews
Address 399 0
Level 6, Lifehouse, 119-143 Missenden Road, Camperdown NSW 2050
Country 399 0
Australia
Phone 399 0
+61 2 8071 4881
Fax 399 0
Email 399 0
[email protected]