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Clinical Trial 20087

Cancer Type: Gynecological Tumor
Study Type: Treatment
NCT#: NCT03555422

Phase: Phase III
Principal Investigator: Chon, Hye Sook

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Overview

Study Title

A Randomized, Double-Blind, Phase 3 Trial Of Maintenance With Selinexor/Placebo After Combination Chemotherapy For Patients With Advanced Or Recurrent Endometrial Cancer

Summary

Patients with recurrent and advanced endometrial cancer with response after first or second-line chemotherapy will be randomized to maintenance therapy with 80 mg selinexor once weekly or placebo until progression. The purpose of this research study is to see if selinexor can help keep endometrial cancer in remission.

Objective

Primary Objective: To evaluate and compare the efficacy of selinexor compared to placebo, as assessed by the investigator, as maintenance therapy in patients with advanced or recurrent endometrial cancer. Secondary Objectives: To evaluate and compare the efficacy of selinexor compared to placebo, as assessed by a blinded independent central review(BICR), to evaluate and compare selinexor and placebo on survival rates, to evaluate and compare selinexor and placebo for time to subsequent therapies, to evaluate and compare selinexor and placebo for efficacy on subsequent therapy, to evaluate and compare selinexor and placebo for disease control, to evaluate health-related quality of life (HR-QoL) outcomes, to assess the safety and tolerability of selinexor. Exploratory Objectives: To evaluate and compare selinexor and placebo on tumor response rate, to evaluate and compare selinexor and placebo on duration of response, to identify predictive biomarkers of response to treatment and explore treatment mechanism of action using genomics analyses, and to evaluate the pharmacokinetics (PK) of selinexor used as maintenance therapy.

Treatments

Therapies

Therapy (NOS)

Medications

KPT-330 (Selinexor); Placebo (); Selinexor ()

Inclusion Criteria

  • Written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure.
  • 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 or complete remission according to RECIST Version 1.1 for: (a) Primary Stage IV disease, defined per protocol or (b) at first relapse (i.e., relapse after primary therapy including surgery and/or chemotherapy for Stage I-IV disease) as defined per protocol or (c) Had Stage IV disease at diagnosis and received initially chemotherapy with or without surgery and relapsed later. At the time of relapse, patients 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. Patients 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
  • Patients must be be able to initiate study drug 5-8 weeks after completion of their final dose of chemotherapy.
  • ECOG performance status of 0-1
  • Patients must have an adequate bone marrow function and organ function as outlined per protocol
  • Life expectancy of at least 12 weeks
  • Patients must be fit to receive experimental therapy
  • Patient's age > 18 years
  • 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 patients 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.
  • Other criteria may apply

  • Exclusion Criteria

  • Sarcomas, small cell carcinoma with neuroendocrine differentiation, clear cell carcinomas.
  • Concurrent cancer therapy
  • Previous treatment with XPO1 Inhibitor
  • Concurrent treatment with an investigational agent or participation in another clinical trial.
  • Patients 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 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.
  • Major injuries or surgery within the past 14 days prior to start of study treatment with and/or planned surgery during the on-treatment study period.
  • Previous malignant disease, except patients with other malignant disease, for which the patient has been disease-free for at least three years. Concurrent other malignant disease except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
  • Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; however, prophylactic use of these agents is acceptable even if parenteral
  • Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety or compliance with the protocol.
  • Known contraindications to selinexor.
  • Known uncontrolled hypersensitivity to the investigational drugs, or to their excipients
  • History of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 3 months.
  • History of clinically significant haemorrhage in the past 3 months.
  • 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, except alopecia.
  • Active brain metastases (e.g. stable for >Leptomeningeal disease.
  • Unstable cardiovascular function: (a) Symptomatic ischemia, or (b) Uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on anti-arrhythmia are excluded; 1st degree AV block or asymptomatic LAFB/RBBB will not be excluded), or (c) Congestive heart failure (CHF) of NYHA Class ≥3, or (d) Myocardial infarction (MI) within 3 months
  • Pregnancy or breastfeeding. Patients with preserved reproductive capacity, unwilling to use 2 medically acceptable methods of contraception for the duration of the trial and for 3 months afterwards.
  • Active or chronic hepatitis C and/or B infection
  • Patients unable to swallow tablets, patients with malabsorption syndrome, or any other GI disease or GI dysfunction that could interfere with absorption of study treatment 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).
  • Patients unwilling to comply with the protocol.

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