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Phase II Study of KPT-330 (Selinexor) in Female Patients With Advanced Gynaecologic Malignancies & Metastatic Breast Cancer (SIGN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02025985
Recruitment Status : Completed
First Posted : January 1, 2014
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

Study Description
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Brief Summary:
The primary trial objective is to determine the efficacy of KPT-330 (selinexor) in patients 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 RECIST 1.1 criteria).

Condition or disease Intervention/treatment Phase
Ovarian Carcinoma Endometrial Carcinoma Cervical Carcinoma Breast Cancer Drug: Selinexor Phase 2

Detailed Description:
There are two different dosing schedules for ovarian cancer patients. Two additional treatment schedules will be explored in the ovarian cohort to optimize the dosing schedule in a patient population with ovarian carcinoma. Two parallel cohorts of patients with breast carcinoma will also be enrolled.
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Determine efficacy of selinexor in advanced or metastatic gynaecological cancers or breast cancer. [ Time Frame: Up to 24 months ]
    Assessed by Overall Survival (OS).


Other Outcome Measures:
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025985


Locations
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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
Sponsors and Collaborators
Karyopharm Therapeutics Inc
Investigators
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Principal Investigator: Ignace Vergote, MD Universitaire Ziekenhuizen Leuven
Principal Investigator: Patrick Neven, MD, PhD Universitaire Ziekenhuizen Leuven
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Karyopharm Therapeutics Inc:
Karyopharm
KPT-330
Selinexor
SIGN
ovarian cancer
 endometrial cancer
cervical cancer
SINE™
breast cancer
HER2 negative
Additional relevant MeSH terms:
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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