Phase II Study of KPT-330 (Selinexor) in Female Patients With Advanced Gynaecologic Malignancies & Metastatic Breast Cancer (SIGN)
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ClinicalTrials.gov Identifier: NCT02025985 |
Recruitment Status :
Completed
First Posted : January 1, 2014
Last Update Posted : July 3, 2018
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Condition or disease | Intervention/treatment | Phase |
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Ovarian Carcinoma Endometrial Carcinoma Cervical Carcinoma Breast Cancer | Drug: Selinexor | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 116 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Open-label Study of Efficacy and Safety of the Selective Inhibitor of Nuclear Export/SINE™ Compound KPT-330 (Selinexor) in Patients With Advanced Gynaecologic Malignancies and Metastatic Breast Cancer |
Study Start Date : | January 2014 |
Actual Primary Completion Date : | February 13, 2017 |
Actual Study Completion Date : | March 22, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Part 1, Selinexor 50mg/m2 twice weekly
3 Cohorts of patients with ovarian, endometrial, or cervical carcinoma will receive oral Selinexor 50 mg/m2 twice weekly.
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Drug: Selinexor
35 mg/m2 twice weekly, 50 mg/m2 twice weekly, 50 mg/m2 once weekly, or 60 mg/m2 twice weekly. Cycles are 4 weeks.
Other Name: KPT-330 |
Experimental: Part 2, Schedule 1, Selinexor 35 mg/m2 twice weekly
Ongoing ovarian carcinoma cohort will receive oral Selinexor 35 mg/m2 twice weekly.
|
Drug: Selinexor
35 mg/m2 twice weekly, 50 mg/m2 twice weekly, 50 mg/m2 once weekly, or 60 mg/m2 twice weekly. Cycles are 4 weeks.
Other Name: KPT-330 |
Experimental: Part 2, Schedule 2, Selinexor 50 mg/m2 once weekly
Ongoing ovarian carcinoma cohort will receive oral Selinexor 50 mg/m2 once weekly.
|
Drug: Selinexor
35 mg/m2 twice weekly, 50 mg/m2 twice weekly, 50 mg/m2 once weekly, or 60 mg/m2 twice weekly. Cycles are 4 weeks.
Other Name: KPT-330 |
Experimental: Part 3, Selinexor 60 mg twice weekly
Breast cancer cohorts will receive oral Selinexor 60 mg twice weekly.
|
Drug: Selinexor
35 mg/m2 twice weekly, 50 mg/m2 twice weekly, 50 mg/m2 once weekly, or 60 mg/m2 twice weekly. Cycles are 4 weeks.
Other Name: KPT-330 |
- Determine the efficacy of KPT-330 (selinexor) by disease control rate (complete response (CR) or partial response (PR) or stable disease (SD), assessed according to RECIST 1.1 criteria). [ Time Frame: 12 weeks ]PET/CT or CT/MRI after12 weeks on treatment and/or until the patient discontinues treatment due to disease progression, death or withdrawal of informed consent.
- Evaluate safety and tolerability. [ Time Frame: During treatment and 30 days after treatment. ]Safety assessments will be based on adverse events, laboratory data, concomitant medications, and the results of physical examinations and vital signs.
- Determine efficacy of selinexor in advanced or metastatic gynaecological cancers or breast cancer. [ Time Frame: Up to 24 months ]Assessed by Overall Survival (OS).
- Evaluate Quality of Life (QoL) [ Time Frame: Change from baseline on the EORTC QLW-C30 after 6 weeks of treatment, after 12 weeks on treatment and approximately every 8 weeks thereafter ]Will be evaluated after 6 weeks of treatment, after 12 weeks on treatment and approximately every 8 weeks thereafter

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ovarian, fallopian tube or peritoneal carcinoma: both platinum refractory and platinum resistant patients, who have received ≥ 1 lines of chemotherapy for relapsed disease (i.e., ≥2 lines of chemotherapy in total).
- Endometrial carcinoma: patients must have received ≥ 1 line of chemotherapy for relapsed or advanced (stage IV, IIIc) disease.
- Cervical carcinoma: patients must have received ≥ 1 lines of chemotherapy for relapsed or advanced (stage IVb) disease.
- Breast cancer: adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection or any other curative treatment.
- Breast cancer: Patients must have received ≥ 1 line of endocrine treatment or chemotherapy for metastatic disease as applicable for the respective breast cancer subtype.
- Breast cancer: Patient must have either triple negative cancer or be hormone receptor positive (i.e., ER+ and/or PR+) and HER2 negative.
- Must have either measurable disease (RECIST 1.1) or evaluable disease outside irradiated field on CT/MRI. A rise in CA-125 or other tumor marker alone is not sufficient.
- ECOG performance status of 0-1.
- Life expectancy of at least 12 weeks.
- Able to swallow and retain oral medication.
Exclusion Criteria:
- Evidence of complete or partial bowel obstruction.
- Gynecological cancer: All non-epithelial cancers of the ovary, fallopian tube, peritoneum, endometrium or cervix as well as neuro-endocrine tumors are excluded.
- Radiation (except planned or ongoing palliative radiation to bone outside of the region of measurable disease) ≤ 3 weeks prior to C1D1.
- Chemotherapy, immunotherapy or systemic anticancer therapy ≤ 3 weeks prior to C1D1.

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): NCT02025985
Belgium | |
UZ Leuven - Universitair ziekenhuis | |
Leuven, Belgium, B-3000 | |
Denmark | |
Aalborg University Hospital | |
Aalborg, Denmark, DK-9100 | |
Rigshospitalet | |
Copenhagen, Denmark, DK-2100 | |
Herlev Hospital | |
Herlev, Denmark, DK-2730 |
Principal Investigator: | Ignace Vergote, MD | Universitaire Ziekenhuizen Leuven | |
Principal Investigator: | Patrick Neven, MD, PhD | Universitaire Ziekenhuizen Leuven |
Responsible Party: | Karyopharm Therapeutics Inc |
ClinicalTrials.gov Identifier: | NCT02025985 |
Other Study ID Numbers: |
KCP-330-005 |
First Posted: | January 1, 2014 Key Record Dates |
Last Update Posted: | July 3, 2018 |
Last Verified: | July 2018 |
Karyopharm KPT-330 Selinexor SIGN ovarian cancer |
endometrial cancer cervical cancer SINE™ breast cancer HER2 negative |
Carcinoma Breast Neoplasms Endometrial Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site |
Breast Diseases Skin Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Diseases |