A phase II basket study of necitumumab for EGFR amplification positive m etastatic solid tumor : WJOG15021M

Phase 2

Recruiting

• Conditions: Esophageal cancer, gastric cancer, small intestine cancer, urothelial cancer, breast cancer

• Registration Number: JPRN-jRCTs041220070
• Lead Sponsor: Kodera Yasuhiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1)Written consent has been obtained from the pat ient after sufficient explanation of the study contents prior to enrollment in the study.
2)Written consent has been obtained from the patient for the collection of blood for ctDNA analysis after sufficient explanation has been given.
3)The patient's age is 20 years or older at the time of obtaining consent.
4)Histologically or cytologically diagnosed with es ophageal, gastric, small intestinal, urothelial, or breast cancer.
5)Diagnosed as EGFR gene amplification positive by FoundationOne CDx or NCC Oncopanel Syste musing tumor specimens, or by FoundationOne Liquid CDx or Guardant360 using blood specimens.
6)No genetic abnormalities in EGFR(excluding am plification),RAS,BRAF,MAP2K,or ERBB2.
7)Unresectable advanced or recurrent esophagea l, gastric, small intestinal, urothelial, or breast cancer.
8)No metastasis to the symptomatic central nervo us system (brain,spinal cord,or meninges).
9)Has measurable lesion according to RECIST guidelines version 1.1
10)Refractory or intolerant to standard chemotherapy.
Esophageal, small bowel, and urothelial cancer: refractory/intolerant to at least 1 regimen.
Gastric cancer: refractory/intolerant to at least 2 regimens
Hormone receptor negative breast cancer: Prior anthracycline and taxane therapy
Hormone receptor positive breast cancer: refractory to hormone therapy and prior anthracycline and taxane therapy
11)ECOG Performance Status of 0 or 1
12)Expected to survive for at least 3 months
13)Latest laboratory values within 7 days prior to enrollment
(1)Neutrophil count >=1,500/mm3
(2)Hemoglobin >= 8.0 g/dL
(3)Platelet count >= 100,000/mm3
(4)Total bilirubin <= 1.5 mg/dL
(5)AST (GOT) <= 100 IU/L (<= 200 IU/L if liver metastasis is present)
(6)ALT (GPT) <=100 IU/L (<= 200 IU/L for patient s with liver metastases)
(7)Serum creatinine <= 1.5 mg/dL, but serum cre atinine >1.5 mg/dL is also eligible if creatinine clearance (CCr) >= 40 mL/min is met.

Exclusion Criteria

1)Has active multiple cancers
2)Has a local infection or systemic active infection that requires treatment
3)Clinically problematic psychiatric disorders that would make enrollment in the study difficult
4) The patient has the following complications
(1)Renal failure
(2)Liver failure
(3)Interstitial pneumonia/pulmonary fibrosis
(4)Unstable angina pectoris
(5)Other complications that the physician in charg e judges to be serious
5)Known to be HER2 positive
Gastric cancer, breast cancer: HER2 test required (only HER2 negative patients are eligible) Esophageal cancer, small intestine cancer, urothelial cancer: Not ineligible even if HER2 test is not performed.
6)History of treatment with EGFR inhibitors
7)History of severe hypersensitivity
8)Received any of the following treatments within the specified time period prior to enrollment in this study
(1)Prior therapy (chemotherapy, molecular target ed therapy, antibody therapy, hormone therapy, immunotherapy, radiation therapy) within 2 weeks prior to enrollment
(2)Underwent major surgery (minor surgery such as lymph node biopsy, needle biopsy, or portimpl antation is not applicable) within 2 weeks prior to enrollment.
9) Pregnant women, lactating women, women who may be currently pregnant, or men and women who do not intend to use contraception.
10) Other cases deemed inappropriate by the physician in charge.

Study & Design

• Study Type: Interventional
• Study Design: Not specified