Clinical Trials List
2024-12-01 - 2028-12-31
Phase III
Recruiting7
ICD-10C54.1
Malignant neoplasm of endometrium
ICD-10C54.2
Malignant neoplasm of myometrium
ICD-10C54.3
Malignant neoplasm of fundus uteri
ICD-10C54.9
Malignant neoplasm of corpus uteri, unspecified
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9182.0
Malignant neoplasm of corpus uteri, except isthmus
A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
-
Trial Applicant
GEORGE CLINICAL ASIA PACIFIC LIMITED
-
Sponsor
Karyopharm Therapeutics Inc.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 王韶靖 Division of Obstetrics & Gynecology
- 黃曉峰 Division of Obstetrics & Gynecology
- 呂亭芳 Division of Obstetrics & Gynecology
- 許世典 Division of Obstetrics & Gynecology
- 吳振豪 Division of Obstetrics & Gynecology
- 孫洛 Division of Obstetrics & Gynecology
- 石宇翔 Division of Obstetrics & Gynecology
- 范鈞婷 Division of Obstetrics & Gynecology
- 劉芝谷 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Cheng-Tao Lin Division of Obstetrics & Gynecology
- 陳威君 Division of Obstetrics & Gynecology
- Chyong-Huey Lai Division of Obstetrics & Gynecology
- Gigin Lin Division of Obstetrics & Gynecology
- 張淑涵 Division of Obstetrics & Gynecology
- Angel Chao Division of Obstetrics & Gynecology
- 周宏學 Division of Obstetrics & Gynecology
- 張宸邠 Division of Obstetrics & Gynecology
- HSIU-JUNG TUNG Division of Obstetrics & Gynecology
- Yun-Hsin Tang Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
2.
Histologically confirmed EC including endometrioid, serous, undifferentiated, and carcinosarcoma.
3.
TP53 wt assessed by NGS, evaluated by a central vendor.
4. Completed at least 12 weeks of platinum-based therapy with or without ICI for Primary Stage IV or at first relapse and achieved confirmed partial or complete response (PR or CR) by imaging, according to RECIST version 1.1.
Treatment for Primary Stage IV disease is defined as:
a.
had first-line platinum-based therapy along with primary or later debulking surgery and achieving an R0 resection (R0 resection indicates a macroscopic complete resection of all visible tumor), and achieved CR after at least 12 weeks platinum-based therapy, and/or continue to have no evidence of disease after at least 12 weeks of chemotherapy and surgery OR
b.
had first-line platinum-based therapy along with primary or later debulking surgery and achieving R1 or R2 resection (incomplete removal of all macroscopic disease) and achieved PR or CR after at least 12 weeks platinum-based chemotherapy, OR
c.
had no surgery and achieved PR or CR after at least 12 weeks platinum-based chemotherapy.
Exclusion Criteria
Has any uterine sarcomas (carcinosarcomas – not excluded), clear cell or small cell carcinoma with neuroendocrine differentiation.
2. Has received a blood or platelet transfusion during the 2 weeks prior to C1D1. Patients’ hemoglobin must be assessed within 2 weeks of screening and at least 1 week post transfusion.
3. Has insufficient time since or not fully recovered from procedures or anti-cancer therapy, defined as:
•
Persisting adverse events from a previous surgery or procedure that has not resolved ≤28 days prior to Day 1 dosing.
4. Has ongoing clinically significant anti-cancer therapy-related toxicities CTCAE Grade >1, with the exception of alopecia. In specific cases, patients whose toxicity has stabilized or with Grade 2 non-hematologic toxicities can be allowed following documented approval by the Sponsor’s Medical Monitor
5. Had palliative radiotherapy within 14 days of the intended C1D1. Palliative radiotherapy may be permitted for symptomatic control of pain from bone metastases, provided that the radiotherapy does not involve target lesions, and the reason for the radiotherapy does not reflect evidence of disease progression.
6. Has any gastrointestinal dysfunctions that could interfere with the absorption of selinexor (eg, bowel obstruction, inability to swallow tablets, malabsorption syndrome, unresolved nausea, vomiting, diarrhea CTCAE v 5.0 > Grade 1).
7. Unable to tolerate two forms of antiemetics prior to each dose for at least 2 cycles will not be eligible for the trial.
8. Has an active, ongoing or uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week of screening.
9. Has a serious psychiatric or medical condition that could interfere with participation in the study or in the opinion of the Investigator would make study involvement unreasonably hazardous.
10. Had previous treatment with an XPO1 inhibitor.
11. Has stable disease or PD on the post-chemotherapy scan or clinical evidence of progression prior to randomization.
12. Has received any systemic anti-cancer therapy including investigational agents ≤3 weeks (or ≤5 half-lives of the drug [whichever is shorter]) prior to C1D1.
13. Has major injuries or any surgery within 14 days prior to C1D1 and/or planned major surgery during the on-treatment study period.
The Estimated Number of Participants
-
Taiwan
20 participants
-
Global
276 participants
