Panitumumab re-challenge strategy for liquid RAS mutation negative metastatic colorectal cancer

JRCT ID: jRCTs031190096

Registered date:01/10/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: RAS/BRAF V600E wild-type unresectable metastatic colorectal cancer
• Date of first enrollment: 06/12/2019
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Panitumumab 6 mg / kg and irinotecan 150 mg / m 2 are administered once every two weeks (14 days) until it meets protocol termination criteria.

Outcome(s)

Primary Outcome

Objective response rate:ORR
(Investigator's judgment based on RECIST guideline ver. 1.1)

Secondary Outcome

Progression free survival:PFS
Time to treatment failure:TTF
Duration of response:DoR
Overall survival:OS
Disease control rate:DCR
Rate of adverse events
ORR, PFS, TTF, DoR, OS, DCR depending on presence or absence of each gene abnormality in ctDNA analysis at the time of discontinuation of administration before and during anti-EGFR antibody rechallenge

Key inclusion & exclusion criteria

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

Include criteria

1)Histological diagnosis of primary colorectal adenocarcinoma.
2)RAS(KRAS/NRAS)and BRAF V600E wild type analyzed by tumor tissue.
3)Intolerant or refractory to chemotherapy including a fluoropyrimidine, oxaliplatin and irinotecan.
4)Complete or partial response to previous chemotherapy including anti-EGFR antibody (cetuximab or panitumumab).
5)Documentation of progression to previous anti-EGFR antibody within 2 months after last anti-EGFR antibody administration.
6)Negative for plasma RAS mutant within 28 days before registration.
7)Time between the end of previous anti-EGFR antibody and the start of protocol treatment with panitumumab plus irinotecan >= 4 months.
8)Measurable disease according to RECIST guideline v1.1.
9)ECOG 0 or 1.
10)Age >= 20 year old.
11)Adequate major organ function assessed within 14 days before registration.
12)Life expectancy of at least 12 weeks.
13)Written informed consent obtained.

Exclude criteria

1)Severe comorbidity.
2)Underwent one of following treatments before protocol treatment;
a. Extensive surgery within 4 weeks.
b. Colostomy/ileostomy within 2 weeks.
c. Chemotherapy within 2 weeks.
d. Radiation therapy within 2 weeks.
3)CTCAE Grade >= 2 adverse events due to previous therapy, which are not recovered.
4)History of severe infusion reactions to anti-EGFR antibody.
5)Intolerant to previous irinotecan therapy.
6)Comorbidity or history of severe pulmonary disease.
7)Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test.
8)Active HCV or HIV infection.
9)Any other patients who are regarded as inadequate for study enrollment by investigators.

Related Information

• Primary Sponsor: Ohta Takashi
• Source(s) of Monetary Support: Takeda Pharmaceutical Company Limited.