NCT06505395
Recruiting
Phase 2
A Phase Ⅱ Randomized, Parallel-group, Open-label, Active-controlled Trial to Assess the Efficacy, Safety and Pharmacokinetics of the Long-acting Octreotide Subcutaneous Injection (SYHX2008) Versus Octreotide Microspheres (Sandostatin LAR@) in Patients With GEP-NET
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 site in 1 country90 target enrollmentStarted: July 30, 2024Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC)
Overview
Brief Summary
The purpose of this study is to compare the effectiveness, safety, pharmacokinetics (PK) of SYHX2008 vs Octreotide Microspheres (Sandostatin LAR@) in patients with advanced, well-differentiated GEP-NET.
Detailed Description
This is a Phase II, open-label randomized study to assess the PK, efficacy, and safety of SYHX2008 in adult patients with well-differentiated GEP-NET. Patients will be randomized to SYHX2008 cohort or Octreotide Microspheres cohort (Sandostatin LAR@).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female patient ≥18 years old;
- •Histologically confirmed, advanced GEP-NET;
- •At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1;
- •Previous treatment with ≤2 systemic antitumor drugs;
- •Patients who do not have liver metastasis, with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and alkaline phosphatase (ALP) levels ≤ 2.5 times the upper limit of normal (ULN) ; and who do have liver metastasis, with ALT and AST ≤ 5 times ULN; Serum total bilirubin \<1.5 times the ULN; absolute neutrophil count (ANC) of ≥1.5×10\^9/L, platelet count of ≥90×10\^9/L, and hemoglobin ≥9 g/dL; or International Normalized Ratio (INR) ≤1.5 ULN and activated partial thromboplastin time (APTT) ≤1.5 ULN;
- •ECOG performance status of 0 to 1
- •Have expected survival of more than 3 months;
- •Adequately understand the study and voluntarily sign the Informed Consent Form;
- •Females patients with reproductive potential must agree to use an effective contraceptive method, for example, intrauterine devices, birth control medicine or condoms, during the study and within 3 months after study treatment discontinuation; or serum pregnancy tests negative and must be non-lactating participants; or males should agree contraception during the study and for within 3 months after study treatment discontinuation.
Exclusion Criteria
- •Uncontrolled or severe diarrhea with significant dehydration;
- •Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection;
- •Anti-tumor therapy received within 4 weeks prior to the initiation of the investigational treatment, for example mammalian target of rapamycin (mTOR) inhibitors or multi-target tyrosine kinase inhibitors (TKI); or short-acting octreotide acetate was received subcutaneously or intravenously within 1 weeks prior to the initiation of the investigational treatment;
- •Interferon was received within 4 weeks prior to the initiation of the investigational treatment; or chemotherapy was received within 4 weeks prior to the initiation of the investigational treatment; or transarterial chemoembolization was received within 12 months prior to screening; or previously received peptide receptor radionuclide therapy (PRRT) at any time; or received radiation therapy, anti-tumor traditional Chinese medicine treatment, hepatic artery intervention embolization, liver metastasis cryoablation or radiofrequency ablation, and other systemic anti-tumor drug treatments within 4 weeks prior to the initiation of the investigational treatment; or had participated in other clinical trials within 30 days prior to screening
- •Surgery (except biopsy) within 28 days prior to the initiation of investigational treatment or unhealed surgical incision;
- •Glycated hemoglobin (HbA1c) \> 8.5%;
- •Patients have symptomatic cholelithiasis or a history of symptomatic cholelithiasis at screening, but with no performed surgery treatment;
- •Patients with active brain metastases or cancerous meningitis meet any of the following criteria: a) Patients with prior brain metastases, imaging within 4 weeks prior to the first use of investigational drug show progression of the original lesion, or new brain metastases; b) Clinical symptoms associated with central nervous system metastasis did not recovery to baseline; c) Use cortisols, radiotherapy and other drugs to control the symptoms of central nervous system metastasis within 4 weeks before the first use of the investigational drug;
- •The adverse reactions of previous antitumor therapy have not returned to ≤ grade 1 according to CTCAE V5.0 (except that the investigators evaluate no safety risk, such as hair loss, grade 2 peripheral neuropathy or dysfunction);
- •Any clinically significant uncontrolled neurological, gastrointestinal, renal (serum creatinine \> 1.5 ULN), pulmonary, or other significant disease requiring exclusion assessed in the opinion of the Investigator;
Arms & Interventions
SYHX2008 injection
Experimental
Intervention: SYHX2008 injection (Drug)
Octreotide Microspheres cohort (Sandostatin LAR@)
Active Comparator
Intervention: Sandostatin LAR@ (Drug)
Outcomes
Primary Outcomes
Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC)
Time Frame: Up to 1 years following the last patient enrolled
PFS is defined as time from the date of randomization to the date of the first documented disease progression as per RECIST 1.1 or death due to any cause (whichever occurs first)
Secondary Outcomes
- Overall response rate(ORR)(Up to 1 years following the last patient enrolled)
- Overall survival (OS)(Up to 1 years following the last patient enrolled)
- Duration of response (DOR)(Up to 1 years following the last patient enrolled)
- PFS as assessed by local Investigators(Up to 1 years following the last patient enrolled)
- Disease control rate (DCR)(Up to 1 years following the last patient enrolled)
- Control of cancer-like symptoms (diarrhea and/or flushing)(Up to 1 years following the last patient enrolled)
- Time to Tomor Progression(TTP)(Up to 1 years following the last patient enrolled)
- Incidence of treatment-emergent adverse events(Up to 1 years following the last patient enrolled)
Investigators
Study Sites (1)
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