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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05076786
Other study ID # HS-3125
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 27, 2021
Est. completion date October 15, 2024

Study information

Verified date September 2021
Source Peking Union Medical College Hospital
Contact Chunmei Bai, M.D.
Phone 69158706
Email baichunmei1964@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to explore the efficacy and safety of chidamide combined with etoposide and cisplatin/carboplatin in the first-line treatment of advanced extrapulmonary neuroendocrine carcinoma.


Description:

This study is a single-arm, multi-center, two-stage, phase II clinical trial conducted in China. This study adopts Simon's two-stage design, and the inclusion criteria and exclusion criteria of the two stages were consistent. Twelve patients with extrapulmonary neuroendocrine carcinoma will be enrolled in the first stage. If more than four complete or partial responses were seen at planned interim analysis, the additional 16 patients will be recruited in the second stage and a total of 28 patients will be treated.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date October 15, 2024
Est. primary completion date October 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age = 18 years; 2. Histologically confirmed locally advanced and metastatic extrapulmonary neuroendocrine carcinoma; 3. No systematic treatments for neuroendocrine carcinoma are received before enrollment; 4. ECOG = 2; 5. Have at least one measurable lesion according to RECIST version 1.1, and the lesion has not received any local treatments; 6. Absolute neutrophil count = 1.5×109 / L, platelet count = 100×109 / L, hemoglobin = 90 g/L; 7. Have ability to sign a written informed consent. Exclusion Criteria: 1. Have surgery or trauma within 4 weeks before enrollment, or are expected to receive surgical treatment; 2. Previous use of HDAC inhibitors; 3. Allergy to related drug components; 4. Have a medical history of immune deficiency diseases, or organ transplantation; 5. Have uncontrolled or significant cardiovascular disease; 6. Abnormal liver function (total bilirubin > 1.5×upper limit of normal); Transaminases (ALT/AST) >2.5×upper limit of normal (>5x upper limit of normal for patients with liver metastases), abnormal renal function (serum creatinine > 1.5×upper limit of normal); 7. Pregnancy ; 8. Have serious diseases that may endanger the safety of patients, or affect patients to complete the research; 9. Any serious mental or cognitive disorder; 10. Patients are currently enrolled in another drug clinical trial within 4 weeks prior to enrollment; 11. Any other condition which is inappropriate for the study in the opinion of the investigators.

Study Design


Intervention

Drug:
Chidamide
20mg, administered orally. Week 1/2: twice a week (d0, d4, d7, d11); Week 3: stop. Repeat every 3 weeks for 4-6 cycles.
Etoposide + Cisplatin/Carboplatin
Etoposide (100mg/m2; intravenous infusion; d1-3) + Cisplatin (75mg/m2; intravenous infusion; d1). Repeat every 3 weeks for 4-6 cycles. OR Etoposide (100mg/m2; intravenous infusion; d1-3) + Cisplatin (25mg/m2; intravenous infusion; d1-3). Repeat every 3 weeks for 4-6 cycles. OR Etoposide (100mg/m2; intravenous infusion; d1-3) + Carboplatin (AUC=5; intravenous infusion; d1). Repeat every 3 weeks for 4-6 cycles.

Locations

Country Name City State
China Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Beijing Beijing
China Harbin Medical University Cancer Hospital Harbin Heilongjiang
China The First Affiliated Hospital of Xiamen University Xiamen Fujian

Sponsors (3)

Lead Sponsor Collaborator
Peking Union Medical College Hospital Harbin Medical University, The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate (ORR) Percentage of participants with complete response and partial response, assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 Up to 2 years
Secondary Disease Control Rate (DCR) Percentage of participants with complete response, partial response, and stable disease assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 Up to 2 years
Secondary Progression-free Survival (PFS) Time from the date of enrollment until progression or death, whichever is first met Time from the date of enrollment to the earliest of documented disease progression or death, assessed up to 2 years
Secondary Overall Survival (OS) Time from the date of enrollment until death Time from the date of enrollment to the earliest of documented death, assessed up to 3 years
Secondary Treatment-related Adverse Events (Safety) Frequency and grade of adverse events (the grade of adverse events is assessed according to CTCAE v4.03). Up to 2 years
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