Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms

NCT05316480 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: PTCA199-1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The phase II study is performed to assess the efficacy and safety of Nimotuzumab in patients with stage IV pancreatic neuroendocrine neoplasms and EGFR overexpression.

Conditions

Pancreatic Neuroendocrine Neoplasm

Keywords

EGFR; nimotuzumab; Pancreatic Neuroendocrine Neoplasm

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Overall Response rate was defined as the proportion of patients with a best overall response of complete response or partial response, based on investigator's assessment as per RECIST criteria version 1.1.

  Baseline to 6 months

Secondary Outcomes (3)

• Disease control rate (DCR)

  Baseline to 6 months

• Progression free survival (PFS)

  Patients will be followed until disease progression, estimating around 12months

• Overall survival (OS)

  Patients will be followed until disease progression, estimating around 12months

Study Arms (1)

Nimotuzumab

EXPERIMENTAL

nimotuzumab 200mg/week

Drug: Nimotuzumab

Interventions

Nimotuzumab DRUG

nimotuzumab 200mg/week

Nimotuzumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically proven diagnosis of pancreatic neuroendocrine tumors (pNET) with well and moderately differentiated with evidence of unresectable disease or metastatic disease. Locally advanced disease must not be amendable to resection or radiation therapy with curative intent.
• Overexpression of EGFR in tumor tissue sample from tumor biopsy or prior primary tumor resection. Therefore availability of paraffin-embedding tumor tissue sample is needed.
• Documented progression of the disease by CT scan, MRI, or Octreoscan within 12 months prior to baseline.
• Measurable disease as per RECIST. Measurable lesions that have been previously radiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
• Male or female, 18 years of age or older.
• ECOG performance status less than 2.
• Life expectancy greater than 12 weeks.
• The definitions of minimum adequacy for organ function required prior to study entry are as follows.
• Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) \< 2.5 x upper limit of normal (ULN), or AST and ALT \< 5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin \< 1.5 x ULN Serum albumin \> 3.0 g/dL Absolute neutrophil count (ANC) \> 1500/L Hemoglobin \> 9.0 g/dL Creatinin clearance \< 40 mL/min
• Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

You may not qualify if:

• Active second primary malignancy or history of second primary malignancy.
• Current treatment on another clinical trial.
• Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus.
• Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to randomization.
• Pathological confirmed to be poor differentiated tumor of pancreatic neuroendocrine neoplasms.
• Patients who are unwilling or unable to comply with study procedures.
• Prior targeted treatment on EGFR.
• Low expression or absence of EGFR in tumor tissue sample from tumor biopsy or prior primary tumor resection.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Adenoma, Islet Cell

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 7, 2022
• Study Start: May 1, 2022
• Primary Completion: April 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 7, 2022

Record last verified: 2022-03

Locations

CN (1)