Phase II Study of KPT-330 (Selinexor) in Female Patients With Advanced Gynaecologic Malignancies
This trial is active, not recruiting.
|Conditions||ovarian carcinoma, endometrial carcinoma, cervical carcinoma, breast cancer|
|Sponsor||Karyopharm Therapeutics, Inc|
|Start date||January 2014|
|End date||December 2016|
|Trial size||106 participants|
|Trial identifier||NCT02025985, KCP-330-005|
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).
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Leuven, Belgium||UZ Leuven - Universitair ziekenhuis||no longer recruiting|
|Aalborg, Denmark||Aalborg University Hospital||no longer recruiting|
|Copenhagen, Denmark||Rigshospitalet||no longer recruiting|
|Herlev, Denmark||Herlev Hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
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
Evaluate safety and tolerability.
time frame: During treatment and 30 days after treatment.
Determine efficacy of selinexor in advanced or metastatic gynaecological cancers or breast cancer.
time frame: Up to 24 months
Female participants at least 18 years old.
- 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.
- 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.
|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|
|Principal investigator||Ignace Vergote, MD|
|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.|
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