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

JRCT ID: jRCTs041220070

Registered date:07/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer, gastric cancer, small intestine cancer, urothelial cancer, breast cancer
• Date of first enrollment: 30/11/2022
• Target sample size: 22
• Study type: Interventional
• Intervention(s): Necitumumab 800 mg, IV over 60 minutes, given o n days 1 and 8, repeated every 3 weeks

Outcome(s)

• Primary Outcome: Objective response rate: ORR

Secondary Outcome

Duration of response: DoR
Progression-free survival: PFS
Overall survival: OS
Time to treatment failure: TTF
Disease control rate: DCR
Incidence of adverse events
The rate of tumor shrinkage
Dose intensity
Association between EGFR copy number (CN) before treatment and efficacy
Association between change in EGFR CN (before treatment and before the initiation of the second course) and efficacy

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kodera Yasuhiro
• Secondary Sponsor: West Japan Oncology Group
• Source(s) of Monetary Support: Aichi Cancer Center Hospital,Ministry of Health, Labour and Welfare