BiTS Study

JRCT ID: jRCTs051180184

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: metastatic colorectal carcinoma
• Date of first enrollment: 02/10/2017
• Target sample size: 45
• Study type: Interventional

Intervention(s)

Biweekly TAS-102 plus Bevacizumab.
Phase Ib part was designed to evaluate the incidence of dose limiting toxicities during the first course and to determine the recommended phase II dose (RP2D) in the dose de-escalation design (3+3) with TAS-102 (35mg/m2 given orally twice daily on day1-5 for 2weeks) and biweekly Bevacizumab.
In phase II part, using the RD of TAS-102 determined in phase Ib, concomitant administration of Bevacizumab 5mg/kg/2weeks until PD.

Outcome(s)

Primary Outcome

Phase Ib part MTD
Phase II part 16w PFS rate by investigators' assessment

Secondary Outcome

Progression free survival
Time to treatment failure
Overall survival
Objective response rate
Disease control rate
Adverse event rate

Key inclusion & exclusion criteria

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

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kato Takeshi
• Secondary Sponsor: Epidemiological and Clinical Research Information Network (ECRIN)
• Secondary ID(s): UMIN000029198