A Phase I/II Study Using Cabozantinib and Lanreotide as Treatment for Advanced Gastroenteropancreatic Neuroendocrine Tumors That Failed Molecular Targeted Therapies or Chemotherapy (SCALET)

Who is this study for? Patients with advanced gastroenteropancreatic neuroendocrine tumors
What treatments are being studied? Cabozantinib+Lanreotide
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This is an Open-Label Phase I/II Study of daily cabozantinib plus lanreotide every 4 w eeks to treat advanced G1-2 gastroentero-pancreatic neuroendocrine tumor (GEP-NET) patients who failed to one line or more than one line of small molecule kinase inhibitor or well-differentiated (W-D) G3 GEP-NET who failed to one line of small molecule kinase inhibitor or chemotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• Pathologically confirmed G1 or G2 NET of GEP origin with locally advanced or metastatic stage who failed to one line or more than one line of small molecular kinase inhibitor (mTOR inhibitor or other targeted kinase inhibitor) or W-D G3 NET of GEP origin with locally advanced or metastatic stage who failed to one line or more than one line of chemotherapy or small molecule kinase inhibitor.

• Radiologic progression within 12 months of entry

• Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically non-significant and/or stable on supportive therapy.

• Age≥ 20 years old and ECOG Performance Status ≤ 1.

• Adequate organ and marrow function, based upon meeting all the following laboratory criteria within 14 days before first dose of study treatment:

∙ Absolute neutrophil count (ANC) ≥ 1500/µL without granulocyte colony- stimulating factor support.

‣ White blood cell count ≥ 2500/µL.

‣ Platelets ≥ 100,000/µL without transfusion.

‣ Hemoglobin ≥ 9 g/dL (≥ 90 g/L).

‣ Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x upper limit of normal (ULN). If there is liver metastasis, AST, ALT ≤ 5 x ULN. ALP ≤ 5 x ULN with documented bone metastases.

‣ Total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert's disease ≤ 3 x ULN).

‣ Serum albumin ≥ 2.8 g/dl

‣ (PT)/INR or partial thromboplastin time (PTT) test \< 1.3 x the laboratory ULN

‣ Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 50 mL/min (≥ 0.5 mL/sec) using the Cockcroft-Gault equation:

∙ Males: (140 - age) x weight (kg)/(serum creatinine \[mg/dL\] × 72) Females: \[(140 - age) x weight (kg)/(serum creatinine \[mg/dL\] ×72)\] × 0.85

∙ Urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol), or 24-h urine protein ≤ 1 g

• At least one measurable lesion according to RECIST 1.1 over non-locally treated site, such as RT, TAE (TACE), or RFA.

• Life expectancy greater than 12 weeks.

• Capable of understanding and complying with the protocol requirements and must have signed informed consent document.

• Female subjects of childbearing potential (i.e. less than or equal to 2 years post-menopause and not surgically sterile) and their partners must agree to use highly effective methods of contraception (that alone or in combination result in a failure rate of less than 1% per year when used consistently and correctly during the course of the study and for 4 months after the last dose of study treatment.

• \* Effective methods of birth control include:

⁃ Hormonal contraception (oral, injectable, implantable, transdermal) plus a barrier method;

⁃ intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) plus a barrier method;

⁃ bilateral tubal occlusion (females);

⁃ vasectomized partner (males).

⁃ Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria are met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \< 55 years-of-age must have a serum follicle stimulating (FSH) level \> 40 mIU/mL to confirm menopause). Note: Documentation may include review of medical records, medical examinations, or medical history interview by study site.

Locations
Other Locations
Taiwan
Changhua Christian Hospital
RECRUITING
Changhua
Chang Gung Medical Foundation
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
China Medical University Hospital
RECRUITING
Taichung
Taichung Veterans General Hospital
RECRUITING
Taichung
National Cheng Kung University Hospita
RECRUITING
Tainan
Mackay Memorial Hospital
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Tri-Service General Hospital
RECRUITING
Taipei
Chang Gung Medical Foundation
RECRUITING
Taoyuan District
Contact Information
Primary
Ya-Ling Wu, BS
yalin@nhri.edu.tw
886-3-7206166
Backup
Hui-Jen Tsai, PhD
hjtsai@nhri.org.tw
886-6-2353535
Time Frame
Start Date: 2021-09-17
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 49
Treatments
Experimental: Cabozantinib and Lanreotide
Oral cabozantinib 40-60 mg/day and lanreotide 120mg deep subcutaneous injection (SC) in day 1 every 4 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Mackay Memorial Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Taichung Veterans General Hospital, Taipei Veterans General Hospital, Taiwan, Changhua Christian Hospital, National Taiwan University Hospital, China Medical University Hospital, National Cheng-Kung University Hospital, Tri-Service General Hospital
Leads: National Health Research Institutes, Taiwan

This content was sourced from clinicaltrials.gov