A Phase 2 interventional study of Selinexor in Ovarian Carcinoma, Endometrial Carcinoma and Cervical Carcinoma, sponsored by Karyopharm Therapeutics Inc. Completed at 4 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-26.
Sponsored by Karyopharm Therapeutics Inc · Phase 2, Interventional, and Treatment
The primary trial objective is to determine the efficacy of KPT-330 (selinexor) in participants with advanced or metastatic gynaecological cancers by disease control rate (complete response (CR) or partial response (PR) or stable disease (SD) for at least 12 weeks, assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Two-stage Phase 2 study in 3 separate gynecological cancer cohorts, with an additional set of participants in the ovarian cohort randomized into 2 different treatment regimens. The study is divided between a Primary Treatment Phase and a Maintenance Phase with each phase supported by a separate database.
Part 1 - Three parallel cohorts of participants with ovarian (Cohort A), endometrial (Cohort B), or cervical (Cohort C) carcinoma were enrolled.
Part 2 - Based on the observed tolerability and efficacy profile in the ongoing ovarian cohort (Cohort A), 2 additional treatment schedules will be explored to optimize the dosing schedule in a participant population with ovarian carcinoma.
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Adequate hematologic function defined as:
Ovarian, fallopian tube, or peritoneal carcinoma: both platinum refractory* and platinum resistant** participants, who have received ≥1 line of chemotherapy for relapsed disease (i.e., ≥2 lines of chemotherapy in total).
*Platinum refractory is defined as progression during or within 4 weeks of last treatment with a platinum-containing therapy.
**Platinum resistant is defined as relapse 4 weeks to \<6 months after a platinum-containing therapy.
Exclusion Criteria:
Disease-Specific Exclusions:
Unstable cardiovascular function:
Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 milligram per meter square (mg/m\^2) of selinexor oral tablets twice weekly (BIW) (doses at least 36 hours apart) with light meal and 120 milliliters (mL) of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 once weekly (QW). This treatment continued until progression of disease (PD) or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Drug: Selinexor
Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Drug: Selinexor
Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Drug: Selinexor
Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Drug: Selinexor
Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Drug: Selinexor
Route of administration and dosage form: Oral tablet; Doses: 35 mg/m\^2 BIW, 35 mg/m\^2 QW, 50 mg/m\^2 BIW, 50 mg/m\^2 QW, 60 mg/m\^2 BIW, 60 mg/m\^2 QW. Treatment cycles were 4 weeks each i.e., 28 day cycles.
Also known as: KPT-330, XPOVIO
Percentage of Participants With Disease Control Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Disease Control Rate (DCR) was defined as the point estimate of the percentage of participants who had complete response (CR), partial response (PR), or stable disease (SD) for at least 12 weeks, assessed according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Participants without documented disease progression were censored on the date of last radiologic assessment.
Time frame: Baseline up to 30 days after last dose administration, assessed after 6 weeks and 12 weeks (approximately 35 months)
Percentage of Participants With Overall Response According to RECIST v1.1
Overall Response Rate (ORR) was defined as the point estimate of the percentage of participants who had CR or PR, assessed according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Baseline up to the date of progression or recurrence (approximately 35 months)
Percentage of Participants With Disease Control According to Gynecological Cancer Intergroup (GCIG) Response Criteria
DCR was defined as the point estimate of the percentage of participants who had CR, PR, or SD for at least 12 weeks, assessed according to GCIG response criteria (RECIST v1.1 and CA-125).
Time frame: Baseline up to 30 days after last dose administration, assessed after 6 weeks and 12 weeks (approximately 35 months)
Percentage of Participants With Overall Response According to GCIG Response Criteria
ORR was defined as the point estimate of the percentage of participants who had CR or PR, assessed according to GCIG response criteria (RECIST v1.1 and CA-125).
Time frame: Baseline up to the date of progression or recurrence (approximately 35 months)
Progression-free Survival (PFS) According to RECIST v1.1
PFS was defined as the time from date of start of study therapy to the date of tumor disease progression (i.e., radiological only) or date of death due to any cause. Participants without documented disease progression were censored at the time of last radiologic assessment. Participants without any post baseline assessments were censored at date of start of study therapy.
Time frame: From start of study drug administration until PD or discontinuation from the study or death, whichever occurred first (approximately 35 months)
Overall Survival (OS)
OS was defined as time from the date of start of study therapy to the date of death due to any cause. Participants who were alive at the time of the analysis or were lost to follow-up were censored at the day they were last known to be alive. Kaplan-Maier method was used for estimation.
Time frame: From start of study treatment up to the date of death, assessed every 3 months (approximately 35 months)
Percentage of Participants Who Survived at 12 and 24 Months
OS rate was reported as the percentage of participants who were alive at 12 and 24 months. OS was defined as time from the date of start of study therapy to the date of death due to any cause. Participants who were alive at the time of the analysis or are lost to follow-up were censored at the day they were last known to be alive. Survival rate were estimated by Kaplan-Maier method.
Time frame: 12 and 24 months
Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAE) According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product. A serious adverse event (SAE) was defined as an AE that meets one or more of the mentioned criteria, i.e., fatal, life threatening (places the participants at immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events. TEAE was defined as any AE (serious/non-serious) with onset or worsening of a pre-existing condition on or after the first administration of study medication through 30 days following last dose or any event considered drug-related by the investigator through the end of the study.
Time frame: From start of study treatment up to 30 days after the last dose administration (approximately 35 months)
Number of Participants With Treatment-emergent Adverse Events by Severity According to National Cancer Institute Common Terminology Criteria for Adverse Events NCI CTCAE, Version 4.03
AE: any unfavorable and unintended sign, symptom, or disease temporally associated with use of medicinal product, whether or not it is considered related to medicinal product. TEAE: any AE (serious/non-serious) with onset or worsening of a pre-existing condition on or after the first administration of study drug through 30 days following last dose or any event considered drug-related by investigator through end of study. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.
Time frame: From start of study treatment up to 30 days after the last dose administration (approximately 35 months)
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores
EORTC QLQC30: Disease specific indication that rates overall QoL in cancer participants. It consists of 30 general questions from 3 domains; 1) global health status, 2) functioning scales (physical, emotional, cognitive, social and role functioning), 3) symptom scales (fatigue, nausea, vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhea, financial difficulty). Out of 30 questions, 28 questions were scored using scale of 1 to 4, represented answers of 'not at all', 'a little', 'quite a bit', and 'very much'; remaining 2 questions contributed to global health status were scored on scale of 1 to 7, represented range of 'very poor' to 'excellent' that evaluated overall health and QoL. All scales and single-item measures range from 0 to 100, where higher score represented higher response level. Higher score for functional scale, global health status and symptom scale represented high level of functioning, high QoL, and high level of symptoms or problems, respectively.
Time frame: Baseline, End of treatment (EOT) i.e., 30 days after last dose of study drug administration (up to 31 months)
Number of Participants With Individual Clinically Significant Abnormalities in Laboratory Tests
Clinically significant laboratory tests abnormalities were analyzed and reported for this outcome measure.
Time frame: From start of study treatment up to 30 days after the last dose administration (approximately 35 months)
The study was conducted between 09-April-2014 and 29-Mar-2017.
| Milestone | Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIWmg/m^2 | Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW |
|---|---|---|---|---|---|
| Started | 25 | 23 | 25 | 21 | 20 |
| Modified intent-to-treat(mitt)population | 23 | 22 | 25 | 21 | 20 |
| Completed | 0 | 0 | 0 | 0 | 0 |
| Not completed | 25 | 23 | 25 | 21 | 20 |
| Withdrew: Consent withdrawn | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Termination of study by sponsor | 4 | 3 | 1 | 1 | 3 |
| Withdrew: Death | 21 | 20 | 23 | 20 | 17 |
Disease Control Rate (DCR) was defined as the point estimate of the percentage of participants who had complete response (CR), partial response (PR), or stable disease (SD) for at least 12 weeks, assessed according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Participants without documented disease progression were censored on the date of last radiologic assessment.
| percentage of participants | Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW |
|---|---|---|---|---|---|
| Percentage of Participants With Disease Control Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | 30.4 (13.2 to 52.9) | 36.4 (17.2 to 59.3) | 24.0 (9.4 to 45.1) | 33.3 (14.6 to 57.0) | 30.0 (11.9 to 54.3) |
Overall Response Rate (ORR) was defined as the point estimate of the percentage of participants who had CR or PR, assessed according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
| percentage of participants | Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW |
|---|---|---|---|---|---|
| Percentage of Participants With Overall Response According to RECIST v1.1 | 8.7 (1.1 to 28.0) | 13.6 (2.9 to 34.9) | 4.0 (0.1 to 20.4) | 9.5 (1.2 to 30.4) | 15.0 (3.2 to 37.9) |
DCR was defined as the point estimate of the percentage of participants who had CR, PR, or SD for at least 12 weeks, assessed according to GCIG response criteria (RECIST v1.1 and CA-125).
| percentage of participants | Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW |
|---|---|---|---|
| Percentage of Participants With Disease Control According to Gynecological Cancer Intergroup (GCIG) Response Criteria | 16.0 (4.5 to 36.1) | 23.8 (8.2 to 47.2) | 20.0 (5.7 to 43.7) |
ORR was defined as the point estimate of the percentage of participants who had CR or PR, assessed according to GCIG response criteria (RECIST v1.1 and CA-125).
| percentage of participants | Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW |
|---|---|---|---|
| Percentage of Participants With Overall Response According to GCIG Response Criteria | 4.0 (0.1 to 20.4) | 9.5 (1.2 to 30.4) | 10.0 (1.2 to 31.7) |
PFS was defined as the time from date of start of study therapy to the date of tumor disease progression (i.e., radiological only) or date of death due to any cause. Participants without documented disease progression were censored at the time of last radiologic assessment. Participants without any post baseline assessments were censored at date of start of study therapy.
| days | Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) According to RECIST v1.1 | 79.0 (45.0 to 99.0) | 86.5 (43.0 to 182.0) | 44.0 (43.0 to 141.0) | 85.0 (44.0 to 148.0) | 44.5 (43.0 to 140.0) |
OS was defined as time from the date of start of study therapy to the date of death due to any cause. Participants who were alive at the time of the analysis or were lost to follow-up were censored at the day they were last known to be alive. Kaplan-Maier method was used for estimation.
| days | Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW |
|---|---|---|---|---|---|
| Overall Survival (OS) | 172.0 (62.0 to 372.0) | 226.0 (111.0 to 449.0) | 152.0 (83.0 to 254.0) | 348.0 (149.0 to 401.0) | 173.0 (105.0 to 353.0) |
OS rate was reported as the percentage of participants who were alive at 12 and 24 months. OS was defined as time from the date of start of study therapy to the date of death due to any cause. Participants who were alive at the time of the analysis or are lost to follow-up were censored at the day they were last known to be alive. Survival rate were estimated by Kaplan-Maier method.
| percentage of participants | Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW |
|---|---|---|---|---|---|
| 12 months | 34.8 (16.6 to 53.7) | 31.8 (14.2 to 51.1) | 13.2 (3.4 to 29.9) | 33.3 (14.9 to 53.1) | 25.0 (9.1 to 44.9) |
| 24 months | 21.7 (7.9 to 39.9) | 13.6 (3.4 to 30.9) | 4.4 (0.3 to 18.4) | 19.0 (5.9 to 37.7) | 15.0 (3.7 to 33.5) |
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product. A serious adverse event (SAE) was defined as an AE that meets one or more of the mentioned criteria, i.e., fatal, life threatening (places the participants at immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events. TEAE was defined as any AE (serious/non-serious) with onset or worsening of a pre-existing condition on or after the first administration of study medication through 30 days following last dose or any event considered drug-related by the investigator through the end of the study.
| Participants | Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW |
|---|---|---|---|---|---|
| Participants with TEAE | 25 | 23 | 25 | 21 | 20 |
| Participants with TESAE | 14 | 14 | 6 | 12 | 12 |
AE: any unfavorable and unintended sign, symptom, or disease temporally associated with use of medicinal product, whether or not it is considered related to medicinal product. TEAE: any AE (serious/non-serious) with onset or worsening of a pre-existing condition on or after the first administration of study drug through 30 days following last dose or any event considered drug-related by investigator through end of study. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.
| Participants | Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW |
|---|---|---|---|---|---|
| Mild (Grade 1) | 0 | 0 | 0 | 0 | 0 |
| Moderate (Grade 2) | 3 | 3 | 5 | 5 | 7 |
| Severe (Grade 3) | 19 | 17 | 17 | 15 | 13 |
| Life threatening (Grade 4) | 3 | 2 | 2 | 1 | 0 |
| Fatal (Grade 5) | 0 | 1 | 1 | 0 | 0 |
EORTC QLQC30: Disease specific indication that rates overall QoL in cancer participants. It consists of 30 general questions from 3 domains; 1) global health status, 2) functioning scales (physical, emotional, cognitive, social and role functioning), 3) symptom scales (fatigue, nausea, vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhea, financial difficulty). Out of 30 questions, 28 questions were scored using scale of 1 to 4, represented answers of 'not at all', 'a little', 'quite a bit', and 'very much'; remaining 2 questions contributed to global health status were scored on scale of 1 to 7, represented range of 'very poor' to 'excellent' that evaluated overall health and QoL. All scales and single-item measures range from 0 to 100, where higher score represented higher response level. Higher score for functional scale, global health status and symptom scale represented high level of functioning, high QoL, and high level of symptoms or problems, respectively.
| scores on a scale | Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW |
|---|---|---|---|---|---|
| Global Health Status/ QoL: Baseline | 52.8 ± 22.41 | 59.5 ± 20.63 | 60.2 ± 24.25 | 61.5 ± 22.89 | 57.5 ± 21.95 |
| Global Health Status/ QoL: EOT | -8.3 ± 11.79 | -11.4 ± 29.88 | -14.6 ± 10.49 | -27.4 ± 31.81 | -13.9 ± 15.52 |
| Functioning Scales/ Physical Functioning: Baseline | 69.5 ± 19.16 | 70.9 ± 21.54 | 66.1 ± 26.02 | 67.1 ± 21.14 | 70.7 ± 25.26 |
| Functioning Scales/ Physical Functioning: EOT | -26.7 ± 28.28 | -16.4 ± 27.55 | -24.2 ± 21.32 | -7.6 ± 16.97 | -18.9 ± 14.25 |
| Functioning Scales/ Role Functioning: Baseline | 54.0 ± 29.77 | 59.5 ± 31.87 | 55.6 ± 35.49 | 59.5 ± 28.66 | 63.3 ± 34.45 |
| Functioning Scales/ Role Functioning: EOT | -33.3 ± 47.14 | -3.0 ± 49.90 | -20.8 ± 36.96 | -9.5 ± 39.51 | -25.0 ± 9.13 |
| Functioning Scales/ Emotional Functioning: Baseline | 62.3 ± 24.81 | 69.8 ± 24.65 | 71.2 ± 23.81 | 74.2 ± 19.53 | 66.3 ± 23.33 |
| Functioning Scales/ Emotional Functioning: EOT | -16.7 ± 11.79 | -0.8 ± 38.27 | 12.5 ± 14.43 | -13.9 ± 23.07 | -2.8 ± 17.21 |
| Functioning Scales/ Cognitive Functioning: Baseline | 81.0 ± 22.54 | 86.5 ± 16.35 | 83.3 ± 25.20 | 83.3 ± 19.00 | 80.8 ± 23.12 |
| Functioning Scales/ Cognitive Functioning: EOT | -33.3 ± 23.57 | -6.1 ± 29.13 | 4.2 ± 20.97 | -16.7 ± 38.49 | 0.0 ± 0.00 |
| Functioning Scales/ Social Functioning: Baseline | 61.1 ± 29.97 | 76.2 ± 32.31 | 72.7 ± 28.89 | 69.0 ± 30.86 | 77.5 ± 29.75 |
| Functioning Scales/ Social Functioning: EOT | -33.3 ± 0.00 | -6.1 ± 48.46 | -20.8 ± 20.97 | -7.1 ± 18.90 | -30.6 ± 32.35 |
| Symptom Scales/Items/ Fatigue: Baseline | 46.6 ± 27.80 | 43.4 ± 27.42 | 44.9 ± 27.75 | 46.0 ± 27.28 | 41.7 ± 27.89 |
| Symptom Scales/Items/ Fatigue: EOT | 33.3 ± 47.14 | 6.1 ± 41.09 | 1.4 ± 17.20 | 23.8 ± 30.38 | 16.7 ± 11.65 |
| Symptom Scales/Items/ Nausea And Vomiting: Baseline | 13.5 ± 24.51 | 17.5 ± 30.04 | 9.8 ± 15.99 | 5.6 ± 14.27 | 10.8 ± 21.81 |
| Symptom Scales/Items/ Nausea And Vomiting: EOT | 8.3 ± 11.79 | -0.0 ± 40.82 | 16.7 ± 19.25 | 9.5 ± 23.29 | 13.9 ± 16.39 |
| Symptom Scales/Items/ Pain: Baseline | 34.9 ± 27.84 | 37.3 ± 27.34 | 32.6 ± 27.93 | 31.0 ± 29.48 | 32.5 ± 26.75 |
| Symptom Scales/Items/ Pain: EOT | -8.3 ± 11.79 | -4.5 ± 21.20 | 4.2 ± 8.33 | -2.4 ± 17.82 | 2.8 ± 26.70 |
| Symptom Scales/Items/ Dyspnoea: Baseline | 23.8 ± 31.87 | 30.2 ± 36.37 | 19.7 ± 30.27 | 33.3 ± 38.01 | 21.7 ± 29.17 |
| Symptom Scales/Items/ Dyspnoea: EOT | 50.0 ± 23.57 | 6.1 ± 32.72 | 8.3 ± 16.67 | -0.0 ± 47.14 | 16.7 ± 18.26 |
| Symptom Scales/Items/ Insomnia: Baseline | 31.7 ± 34.12 | 36.5 ± 31.46 | 30.3 ± 32.38 | 20.6 ± 26.82 | 38.3 ± 29.17 |
| Symptom Scales/Items/ Insomnia: EOT | -16.7 ± 23.57 | -9.1 ± 30.15 | -16.7 ± 33.33 | -19.0 ± 26.23 | 5.6 ± 32.77 |
| Symptom Scales/Items/ Appetite Loss: Baseline | 25.4 ± 31.46 | 34.9 ± 32.45 | 30.3 ± 36.96 | 23.8 ± 28.17 | 15.0 ± 27.52 |
| Symptom Scales/Items/ Appetite Loss: EOT | 16.7 ± 23.57 | 0.0 ± 53.75 | 16.7 ± 43.03 | 33.3 ± 47.14 | 16.7 ± 34.96 |
| Symptom Scales/Items/ Constipation: Baseline | 27.0 ± 27.12 | 15.9 ± 24.99 | 15.2 ± 26.68 | 17.5 ± 30.95 | 11.7 ± 16.31 |
| Symptom Scales/Items/ Constipation: EOT | 0.0 ± 47.14 | 6.7 ± 43.89 | 8.3 ± 16.67 | 9.5 ± 31.71 | -5.6 ± 13.61 |
| Symptom Scales/Items/ Diarrhoea: Baseline | 17.5 ± 30.95 | 9.5 ± 26.13 | 18.2 ± 24.62 | 18.3 ± 31.48 | 8.3 ± 14.81 |
| Symptom Scales/Items/ Diarrhoea: EOT | 0.0 ± 0.00 | -3.0 ± 34.82 | 0.0 ± 27.22 | 23.8 ± 25.20 | 27.8 ± 32.77 |
| Symptom Scales/Items/ Financial Difficulties: Baseline | 7.9 ± 17.97 | 4.8 ± 15.94 | 16.7 ± 26.73 | 9.5 ± 18.69 | 5.0 ± 12.21 |
| Symptom Scales/Items/ Financial Difficulties: EOT | 16.7 ± 23.57 | 3.0 ± 17.98 | 0.0 ± 0.00 | 4.8 ± 29.99 | -5.6 ± 13.61 |
Clinically significant laboratory tests abnormalities were analyzed and reported for this outcome measure.
| Participants | Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW |
|---|---|---|---|---|---|
| Number of Participants With Individual Clinically Significant Abnormalities in Laboratory Tests | 21 | 20 | 19 | 14 | 11 |
Collected over From start of study treatment up to 30 days after last dose administration (approximately 35 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW | 21/25 (84%) | 14/25 (56%) | 25/25 (100%) |
| Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW | 20/23 (87%) | 14/23 (60.9%) | 23/23 (100%) |
| Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW | 23/25 (92%) | 6/25 (24%) | 25/25 (100%) |
| Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW | 20/21 (95.2%) | 12/21 (57.1%) | 21/21 (100%) |
| Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW | 17/20 (85%) | 12/20 (60%) | 20/20 (100%) |
| Event | Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW |
|---|---|---|---|---|---|
| VomitingGastrointestinal disorders | 5/25 | 1/23 | 0/25 | 0/21 | 0/20 |
| AscitesGastrointestinal disorders | 2/25 | 0/23 | 0/25 | 0/21 | 4/20 |
| NauseaGastrointestinal disorders | 0/25 | 1/23 | 1/25 | 0/21 | 2/20 |
| General Physical Health DeteriorationGeneral disorders | 0/25 | 0/23 | 0/25 | 0/21 | 2/20 |
| HyponatraemiaMetabolism and nutrition disorders | 0/25 | 2/23 | 0/25 | 0/21 | 0/20 |
| Deep Vein ThrombosisVascular disorders | 0/25 | 2/23 | 0/25 | 0/21 | 1/20 |
| IleusGastrointestinal disorders | 2/25 | 0/23 | 0/25 | 1/21 | 0/20 |
| DehydrationMetabolism and nutrition disorders | 2/25 | 1/23 | 0/25 | 1/21 | 0/20 |
| HyperglycaemiaMetabolism and nutrition disorders | 2/25 | 1/23 | 0/25 | 0/21 | 0/20 |
| Pleural EffusionRespiratory, thoracic and mediastinal disorders | 2/25 | 0/23 | 0/25 | 0/21 | 1/20 |
| Event | Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW |
|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 22/25 | 15/23 | 17/25 | 17/21 | 15/20 |
| Decreased AppetiteMetabolism and nutrition disorders | 12/25 | 18/23 | 12/25 | 16/21 | 10/20 |
| VomitingGastrointestinal disorders | 18/25 | 14/23 | 11/25 | 13/21 | 12/20 |
| Weight DecreasedInvestigations | 12/25 | 13/23 | 18/25 | 11/21 | 6/20 |
| FatigueGeneral disorders | 12/25 | 15/23 | 15/25 | 14/21 | 14/20 |
| AnaemiaBlood and lymphatic system disorders | 13/25 | 11/23 | 14/25 | 9/21 | 5/20 |
| ConstipationGastrointestinal disorders | 7/25 | 6/23 | 6/25 | 11/21 | 7/20 |
| ThrombocytopeniaBlood and lymphatic system disorders | 12/25 | 10/23 | 13/25 | 4/21 | 1/20 |
| DiarrhoeaGastrointestinal disorders | 6/25 | 7/23 | 6/25 | 10/21 | 8/20 |
| DysgeusiaNervous system disorders | 7/25 | 5/23 | 11/25 | 4/21 | 6/20 |
Baseline analysis was performed on safety population that included all participants who had received any amount of study drug.
| Age, Categorical(Participants) | Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 17 | 6 | 20 | 13 | 14 | 70 |
| >=65 years | 8 | 17 | 5 | 8 | 6 | 44 |
| Sex: Female, Male(Participants) | Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW | Total |
|---|---|---|---|---|---|---|
| Female | 25 | 23 | 25 | 21 | 20 | 114 |
| Male | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 25 | 23 | 25 | 21 | 20 | 114 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW | Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW | Total |
|---|---|---|---|---|---|---|
| Race — White | 25 | 23 | 24 | 21 | 20 | 113 |
| Race — Other-unspecified | 0 | 0 | 1 | 0 | 0 | 1 |
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Studies of the drug tested here: Selinexor