BiTS Study

Phase 1

• Conditions: metastatic colorectal carcinoma

• Registration Number: JPRN-jRCTs051180184
• Lead Sponsor: Kato Takeshi

Brief Summary

Biweekly TAS-102 with BEV in combination for patients with mCRC shows promising antitumor efficacy and acceptable toxicity, and might represent a treatment option for patients with heavily treated mCRC.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-26
• Study Completion: 2019-11-05
• Results First Posted: 2020-07-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. written informed consent
2. age >= 20y
3. histologically proven colorectal adenocarcinoma with metastatic disease
4. prior treatment history including fluoropyrimidine, irinotecan, oxaliplatin and anti-EGFR (in case of RAS WT)
5. ECOG PS <2
6. capable oral intake
7. evaluable lesions on the basis of RECIST v1.1
8. adequate organ function
a. Hb >= 8.0 g/dL
b. Neutrophil >= 1500/ mm3
c. Plt >= 75,000/ mm3
d. T-Bil <= 1.5 md/dL
e. AST/ALT <=100IU/L (in case of liver metastasis <= 200 IU/L)
f. serum creatinine <= 1.5 md/dL
9. a woman who have no plan to get pregnant
10. with an appropriate mental capacity

Exclusion Criteria

1. any of the following complication:
a. synchronous active malignancies other than carcinoma in situ or mucosal cancer
b. central nervous system metastases
c. active infection
d. uncontrolled ascites, pleural effusion, pericardial effusion
e. bowel obstruction, renal failure, liver failure,
effusion
f. uncontrolled DM
g. uncontrolled hypertension
h. symptomatic heart disease within 12 months
i. active gastrointestinal bleeding
j. uncontrolled HIV infection, HBV infection, HCV infection
k. immunodeficency
l. sever mental disorder
2. any of the following treatment:
a. thoracotomy, or intestinal resection within 4 weeks
b. chemotherapy within 1 week
c. extensive radiotherapy
d. investigational new drug within 1 week
3. history of TAS-102
4. grade 2 or more adverse events not recovered
5. transfusion within 7 days
6. urine dipstick for proteinuria more than +2
7. severe thrombosis or severe pulmonary disease
8. unhealed wound
9. hemorrhagic diathesis
10. pregnant and lactating females
11. patients judged by the investigator as unfit to be enrolled in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase Ib part MTD <br>Phase II part 16w PFS rate by investigators' assessment

Secondary Outcome Measures

Name	Time	Method
Progression free survival<br>Time to treatment failure<br>Overall survival<br>Objective response rate<br>Disease control rate<br>Adverse event rate