Brief Summary
This is a prospective, multicenter, double-blind, placebo-controlled, randomized Phase 3 study. The purpose of the study is to obtain evidence of efficacy for maintenance selinexor in participants with advanced or recurrent endometrial cancer. Participants with primary stage IV or recurrent disease who are in partial or complete response after having completed a single line of at least 12 weeks of taxane-platinum combo therapy will be randomized in a 2:1 manner to maintenance therapy with 80 milligram (mg) with selinexor once weekly (QW) or placebo until progression.
Brief Title
Maintenance with Selinexor/Placebo After Combination Chemotherapy in Participants with Endometrial Cancer [SIENDO]
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Endometrial Cancer
Eligibility Criteria
Inclusion Criteria:
* Female, at least 18 years of age at the time of informed consent.
* Histological confirmed endometrial cancer of the endometrioid, serous, or undifferentiated type. Carcinosarcoma of the uterus is also allowed.
* Completed a single line of at least 12 weeks of taxane-platinum combination therapy (not including adjuvant or neoadjuvant therapy), and achieved partial remission (PR) or complete remission (CR) according to RECIST version 1.1 for:
* Primary Stage IV disease, defined as:
* had a primary or later debulking surgery during first-line taxane-platinum therapy with R0 resection (R0 resection indicates a macroscopic complete resection of all visible tumor) and achieved CR after at least 12 weeks taxane-platinum chemotherapy, OR
* had a primary or later debulking surgery during first-line taxane-platinum therapy with R1 resection (R1 resection indicates incomplete removal of all macroscopic disease,) and achieved PR or CR after at least 12 weeks taxane-platinum chemotherapy, OR
* had no surgery and achieved PR or CR after at least 12 weeks taxane-platinum chemotherapy.
OR
* At first relapse (i.e., relapse after primary therapy including surgery and/or chemotherapy therapy 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 taxane-platinum chemotherapy compared with the start of this chemotherapy at the time of relapse, OR
* 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 taxane-platinum 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 taxane-platinum chemotherapy compared with the start of this chemotherapy at the time of relapse.
Participants that required their chemotherapy dose held during the 12-week therapy may be considered if they meet the other criteria above and achieve PR or CR per RECIST V1.1.
* Must be able to initiate study drug 5 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 1.5\*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.
* Hematopoetic function: Absolute neutrophil count (ANC) greater than or equal to (≥) 1.5\*10\^9/L; platelet count ≥100\*10\^9 per liter (/L); hemoglobin ≥9.0 gram per deciliter (g/dL).
* Renal function: estimated creatinine clearance (CrCl) of ≥20 milliliter per minute (mL/min), calculated using the Cockroft Gault formula.
* In the opinion of the Investigator, the participant must:
* Have a life expectancy of at least 12 weeks, and
* Be fit to receive experimental 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 1 week following the last dose of study drug.
* Written informed consent in accordance with federal, local, and institutional guidelines. The participant must provide informed consent prior to the first Screening procedure.
Exclusion Criteria:
* Has any sarcomas, small cell carcinoma with neuroendocrine differentiation, or clear cell carcinomas.
* Received a blood or platelet transfusion during 4 weeks prior to randomization.
* Being treated with a concurrent cancer therapy.
* Previous treatment with an exportin 1 (XPO1) inhibitor.
* Previous treatment with anti- programmed cell death protein 1 (PD-1) or anti-programmed cell death ligand-1 (PD-L1) immunotherapy (e.g., pembrolizumab).
* Concurrent treatment with an investigational agent or participation in another clinical trial.
* Participants who received any systemic anticancer therapy including investigational agents or radiation ≤3 weeks (or ≤5 half-lives of the drug \[whichever is shorter\]) prior to cycle 1 day 1 (C1D1). Palliative radiotherapy may be permitted for symptomatic control of pain from bone metastases in extremities, provided that the radiotherapy does not involve target lesions, and the reason for the radiotherapy does not reflect progressive disease (PD).
* Major injuries or surgery within 14 days prior to C1D1 and/or planned surgery during the on-treatment study period.
* Previous malignant disease, except participants with other malignant disease, for which the participant has been disease-free for at least 3 years. Concurrent other malignant disease except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
* Any life-threatening illness, medical condition or organ system dysfunction, which, in the investigator's opinion, could compromise the participant's safety or compliance with the protocol.
* Known contraindications to selinexor.
* Known uncontrolled hypersensitivity to the investigational drug, or to its excipients.
* Radiotherapy to the target lesion within the past 3 months prior to baseline imaging.
* Persistent Grade 3 or 4 toxicity from previous chemotherapy and/or radiotherapy, with the exception of alopecia.
* Active brain metastases (e.g., stable for \<8 weeks, no adequate previous treatment with radiotherapy and/or surgery, symptomatic, requiring treatment with anti-convulsants. Corticoid therapy is allowed if administered as stable dose for at least 1 month before randomization).
* Known unstable cardiovascular function:
* Symptomatic ischemia, or
* Uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on anti-arrhythmia are excluded; 1st degree atrioventricular block or asymptomatic left anterior fascicular block /right bundle branch block will not be excluded), or
* Congestive heart failure of New York Heart Association Class ≥3, or
* Myocardial infarction within 3 months
* Females who are pregnant or actively breastfeeding.
* Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to first dose; however, prophylactic use of these agents is acceptable even if parenteral.
* Active hepatitis C and/or B infection.
* Participants unable to swallow tablets, participants with malabsorption syndrome, or any other gastrointestinal (GI) disease or GI dysfunction that could interfere with absorption of study drug. A history of bowel obstruction requiring a nasogastric tube or intravenous infusion during the past 2 months is not allowed (except when this obstruction is caused by surgery or other non-malignant causes).
* Psychiatric illness or substance use that would prevent the participant from giving informed consent or being compliant with the study procedures.
* Participants unwilling or unable to comply with the protocol.
* Persons who have been committed to an institution by official or judicial order.
* Participants with dependency on the Sponsor, Investigator or study site.
* Female, at least 18 years of age at the time of informed consent.
* Histological confirmed endometrial cancer of the endometrioid, serous, or undifferentiated type. Carcinosarcoma of the uterus is also allowed.
* Completed a single line of at least 12 weeks of taxane-platinum combination therapy (not including adjuvant or neoadjuvant therapy), and achieved partial remission (PR) or complete remission (CR) according to RECIST version 1.1 for:
* Primary Stage IV disease, defined as:
* had a primary or later debulking surgery during first-line taxane-platinum therapy with R0 resection (R0 resection indicates a macroscopic complete resection of all visible tumor) and achieved CR after at least 12 weeks taxane-platinum chemotherapy, OR
* had a primary or later debulking surgery during first-line taxane-platinum therapy with R1 resection (R1 resection indicates incomplete removal of all macroscopic disease,) and achieved PR or CR after at least 12 weeks taxane-platinum chemotherapy, OR
* had no surgery and achieved PR or CR after at least 12 weeks taxane-platinum chemotherapy.
OR
* At first relapse (i.e., relapse after primary therapy including surgery and/or chemotherapy therapy 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 taxane-platinum chemotherapy compared with the start of this chemotherapy at the time of relapse, OR
* 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 taxane-platinum 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 taxane-platinum chemotherapy compared with the start of this chemotherapy at the time of relapse.
Participants that required their chemotherapy dose held during the 12-week therapy may be considered if they meet the other criteria above and achieve PR or CR per RECIST V1.1.
* Must be able to initiate study drug 5 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 1.5\*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.
* Hematopoetic function: Absolute neutrophil count (ANC) greater than or equal to (≥) 1.5\*10\^9/L; platelet count ≥100\*10\^9 per liter (/L); hemoglobin ≥9.0 gram per deciliter (g/dL).
* Renal function: estimated creatinine clearance (CrCl) of ≥20 milliliter per minute (mL/min), calculated using the Cockroft Gault formula.
* In the opinion of the Investigator, the participant must:
* Have a life expectancy of at least 12 weeks, and
* Be fit to receive experimental 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 1 week following the last dose of study drug.
* Written informed consent in accordance with federal, local, and institutional guidelines. The participant must provide informed consent prior to the first Screening procedure.
Exclusion Criteria:
* Has any sarcomas, small cell carcinoma with neuroendocrine differentiation, or clear cell carcinomas.
* Received a blood or platelet transfusion during 4 weeks prior to randomization.
* Being treated with a concurrent cancer therapy.
* Previous treatment with an exportin 1 (XPO1) inhibitor.
* Previous treatment with anti- programmed cell death protein 1 (PD-1) or anti-programmed cell death ligand-1 (PD-L1) immunotherapy (e.g., pembrolizumab).
* Concurrent treatment with an investigational agent or participation in another clinical trial.
* Participants who received any systemic anticancer therapy including investigational agents or radiation ≤3 weeks (or ≤5 half-lives of the drug \[whichever is shorter\]) prior to cycle 1 day 1 (C1D1). Palliative radiotherapy may be permitted for symptomatic control of pain from bone metastases in extremities, provided that the radiotherapy does not involve target lesions, and the reason for the radiotherapy does not reflect progressive disease (PD).
* Major injuries or surgery within 14 days prior to C1D1 and/or planned surgery during the on-treatment study period.
* Previous malignant disease, except participants with other malignant disease, for which the participant has been disease-free for at least 3 years. Concurrent other malignant disease except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
* Any life-threatening illness, medical condition or organ system dysfunction, which, in the investigator's opinion, could compromise the participant's safety or compliance with the protocol.
* Known contraindications to selinexor.
* Known uncontrolled hypersensitivity to the investigational drug, or to its excipients.
* Radiotherapy to the target lesion within the past 3 months prior to baseline imaging.
* Persistent Grade 3 or 4 toxicity from previous chemotherapy and/or radiotherapy, with the exception of alopecia.
* Active brain metastases (e.g., stable for \<8 weeks, no adequate previous treatment with radiotherapy and/or surgery, symptomatic, requiring treatment with anti-convulsants. Corticoid therapy is allowed if administered as stable dose for at least 1 month before randomization).
* Known unstable cardiovascular function:
* Symptomatic ischemia, or
* Uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on anti-arrhythmia are excluded; 1st degree atrioventricular block or asymptomatic left anterior fascicular block /right bundle branch block will not be excluded), or
* Congestive heart failure of New York Heart Association Class ≥3, or
* Myocardial infarction within 3 months
* Females who are pregnant or actively breastfeeding.
* Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to first dose; however, prophylactic use of these agents is acceptable even if parenteral.
* Active hepatitis C and/or B infection.
* Participants unable to swallow tablets, participants with malabsorption syndrome, or any other gastrointestinal (GI) disease or GI dysfunction that could interfere with absorption of study drug. A history of bowel obstruction requiring a nasogastric tube or intravenous infusion during the past 2 months is not allowed (except when this obstruction is caused by surgery or other non-malignant causes).
* Psychiatric illness or substance use that would prevent the participant from giving informed consent or being compliant with the study procedures.
* Participants unwilling or unable to comply with the protocol.
* Persons who have been committed to an institution by official or judicial order.
* Participants with dependency on the Sponsor, Investigator or study site.
Inclusion Criteria
Inclusion Criteria:
* Female, at least 18 years of age at the time of informed consent.
* Histological confirmed endometrial cancer of the endometrioid, serous, or undifferentiated type. Carcinosarcoma of the uterus is also allowed.
* Completed a single line of at least 12 weeks of taxane-platinum combination therapy (not including adjuvant or neoadjuvant therapy), and achieved partial remission (PR) or complete remission (CR) according to RECIST version 1.1 for:
* Primary Stage IV disease, defined as:
* had a primary or later debulking surgery during first-line taxane-platinum therapy with R0 resection (R0 resection indicates a macroscopic complete resection of all visible tumor) and achieved CR after at least 12 weeks taxane-platinum chemotherapy, OR
* had a primary or later debulking surgery during first-line taxane-platinum therapy with R1 resection (R1 resection indicates incomplete removal of all macroscopic disease,) and achieved PR or CR after at least 12 weeks taxane-platinum chemotherapy, OR
* had no surgery and achieved PR or CR after at least 12 weeks taxane-platinum chemotherapy.
OR
* At first relapse (i.e., relapse after primary therapy including surgery and/or chemotherapy therapy 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 taxane-platinum chemotherapy compared with the start of this chemotherapy at the time of relapse, OR
* 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 taxane-platinum 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 taxane-platinum chemotherapy compared with the start of this chemotherapy at the time of relapse.
Participants that required their chemotherapy dose held during the 12-week therapy may be considered if they meet the other criteria above and achieve PR or CR per RECIST V1.1.
* Must be able to initiate study drug 5 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 1.5\*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.
* Hematopoetic function: Absolute neutrophil count (ANC) greater than or equal to (≥) 1.5\*10\^9/L; platelet count ≥100\*10\^9 per liter (/L); hemoglobin ≥9.0 gram per deciliter (g/dL).
* Renal function: estimated creatinine clearance (CrCl) of ≥20 milliliter per minute (mL/min), calculated using the Cockroft Gault formula.
* In the opinion of the Investigator, the participant must:
* Have a life expectancy of at least 12 weeks, and
* Be fit to receive experimental 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 1 week following the last dose of study drug.
* Written informed consent in accordance with federal, local, and institutional guidelines. The participant must provide informed consent prior to the first Screening procedure.
* Female, at least 18 years of age at the time of informed consent.
* Histological confirmed endometrial cancer of the endometrioid, serous, or undifferentiated type. Carcinosarcoma of the uterus is also allowed.
* Completed a single line of at least 12 weeks of taxane-platinum combination therapy (not including adjuvant or neoadjuvant therapy), and achieved partial remission (PR) or complete remission (CR) according to RECIST version 1.1 for:
* Primary Stage IV disease, defined as:
* had a primary or later debulking surgery during first-line taxane-platinum therapy with R0 resection (R0 resection indicates a macroscopic complete resection of all visible tumor) and achieved CR after at least 12 weeks taxane-platinum chemotherapy, OR
* had a primary or later debulking surgery during first-line taxane-platinum therapy with R1 resection (R1 resection indicates incomplete removal of all macroscopic disease,) and achieved PR or CR after at least 12 weeks taxane-platinum chemotherapy, OR
* had no surgery and achieved PR or CR after at least 12 weeks taxane-platinum chemotherapy.
OR
* At first relapse (i.e., relapse after primary therapy including surgery and/or chemotherapy therapy 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 taxane-platinum chemotherapy compared with the start of this chemotherapy at the time of relapse, OR
* 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 taxane-platinum 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 taxane-platinum chemotherapy compared with the start of this chemotherapy at the time of relapse.
Participants that required their chemotherapy dose held during the 12-week therapy may be considered if they meet the other criteria above and achieve PR or CR per RECIST V1.1.
* Must be able to initiate study drug 5 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 1.5\*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.
* Hematopoetic function: Absolute neutrophil count (ANC) greater than or equal to (≥) 1.5\*10\^9/L; platelet count ≥100\*10\^9 per liter (/L); hemoglobin ≥9.0 gram per deciliter (g/dL).
* Renal function: estimated creatinine clearance (CrCl) of ≥20 milliliter per minute (mL/min), calculated using the Cockroft Gault formula.
* In the opinion of the Investigator, the participant must:
* Have a life expectancy of at least 12 weeks, and
* Be fit to receive experimental 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 1 week following the last dose of study drug.
* Written informed consent in accordance with federal, local, and institutional guidelines. The participant must provide informed consent prior to the first Screening procedure.
Gender
Female
Gender Based
false
Keywords
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases
Female
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03555422
Org Class
Industry
Org Full Name
Karyopharm Therapeutics Inc
Org Study Id
KCP-330-024
Overall Status
Active, not recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Randomized, Double-Blind, Phase 3 Trial of Maintenance with Selinexor/ Placebo After Combination Chemotherapy for Patients with Advanced or Recurrent Endometrial Cancer
Primary Outcomes
Outcome Description
Compare progression free survival of the two treatment arms as assessed by the investigator, per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Outcome Measure
Progression Free Survival (PFS)
Outcome Time Frame
Time from randomization until disease progression (PD) or death, whichever occurs first (approximately 12 months after the last participant enrolled)
Secondary Ids
Secondary Id
ENGOT-EN5
Secondary Id
BGOG-EN5
Secondary Id
2017-000607-25
Secondary Outcomes
Outcome Description
Time from randomization until documented PD or death due to any cause, whichever occurs first. Documented PD will be based on BICR assessments.
Outcome Time Frame
Time from randomization until PD or death, whichever occurs first (approximately 12 months after the last participant enrolled)
Outcome Measure
Progression Free Survival: Assessed by Blinded Independent Central Review (BICR), per RECIST v1.1
Outcome Description
Time from randomization until date of death from endometrial cancer.
Outcome Time Frame
Time from randomization until death from endometrial cancer (approximately 12 months after the last participant enrolled)
Outcome Measure
Disease Specific Survival (DSS)
Outcome Description
Time from randomization until date of death from any cause.
Outcome Time Frame
Time from randomization until death (approximately 12 months after the last participant enrolled)
Outcome Measure
Overall Survival (OS)
Outcome Description
Time from randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first.
Outcome Time Frame
Time from randomization until first therapy initiation after discontinuation of study drug or death, whichever occurs first (approximately 12 months after the last participant enrolled)
Outcome Measure
Time to First Subsequent Treatment (TFST)
Outcome Description
Time from randomization until the second documented disease progression or death due to any cause by any cause on any subsequent line of anticancer therapy.
Outcome Time Frame
Time from randomization until second documented PD or death (approximately 12 months after the last participant enrolled)
Outcome Measure
Progression-free Survival After Subsequent Treatment (PFS2)
Outcome Description
Time from randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first.
Outcome Time Frame
Time from randomization until second therapy initiation after discontinuation of study drug or death, whichever occurs first (approximately 12 months after the last participant enrolled)
Outcome Measure
Time to Second Subsequent Treatment (TSST)
Outcome Description
Best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) among patients with PR as best response to prior chemotherapy.
Outcome Time Frame
Time from randomization up to approximately 16 weeks
Outcome Measure
Disease Control Rate (DCR)
Outcome Description
Patient-reported outcomes will be measured by the EORTC QLQ C30 questionnaire.
Outcome Time Frame
Every 12 weeks during study period, at PD and post PD at 3 and 6 months (approximately 12 months after the last participant enrolled)
Outcome Measure
Health-Related Quality of Life (HR-QoL): Measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
Outcome Description
Patient-reported outcomes will be measured by the EORTC QLQ-EN24 questionnaire.
Outcome Time Frame
Every 12 weeks during study period, at PD and post PD at 3 and 6 months (approximately 12 months after the last participant enrolled)
Outcome Measure
Health-Related Quality of Life: Measured by EORTC QLQ-EN24
Outcome Description
Patient-reported outcomes will be measured by the EORTC EQ-5D-5L.
Outcome Time Frame
Every 12 weeks during study period, at PD and post PD at 3 and 6 months (approximately 12 months after the last participant enrolled)
Outcome Measure
Health-Related Quality of Life: Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Outcome Time Frame
From first drug administration up to 30 days after last dose (approximately 12 months after the last patient enrolled)
Outcome Measure
Number of Participants with Treatment Emergent Adverse Events (TEAEs), Occurrence, Nature, and Severity of AEs
Outcome Time Frame
From first drug administration up to 30 days after last dose (approximately 12 months after the last patient enrolled)
Outcome Measure
Number of Participants with Significant Physical Examination, Clinical Laboratory, and Vital Signs Results
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Nicole Nevadunsky
Investigator Email
nnevadun@montefiore.org
Investigator Phone
718-405-8082
Categories Mesh Debug
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Gynecologic Cancers --- UTERINE DISEASES
Prostate Cancer --- UROGENITAL NEOPLASMS
MeSH Terms
ENDOMETRIAL NEOPLASMS
UTERINE NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
UTERINE DISEASES
GENITAL DISEASES
GENITAL NEOPLASMS, FEMALE
UROGENITAL NEOPLASMS
GENITAL DISEASES, FEMALE
FEMALE UROGENITAL DISEASES
FEMALE UROGENITAL DISEASES AND PREGNANCY COMPLICATIONS
UROGENITAL DISEASES
SELINEXOR