UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026043
Receipt number R000029919
Scientific Title Phase 2 trial of TAS-102 plus bevacizumab in patients with advanced/recurrent colorectal cancer who had previously received on oxaliplatin, irinotecan and fluoropyrimidine
Date of disclosure of the study information 2017/02/20
Last modified on 2017/02/08 08:16:05

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Basic information

Public title

Phase 2 trial of TAS-102 plus bevacizumab in patients with advanced/recurrent colorectal cancer who had previously received on oxaliplatin, irinotecan and fluoropyrimidine

Acronym

Phase 2 trial of TAS-102 with bevacizumab in patients with advanced/recurrent colorectal cancer who had previously received on standard therapies

Scientific Title

Phase 2 trial of TAS-102 plus bevacizumab in patients with advanced/recurrent colorectal cancer who had previously received on oxaliplatin, irinotecan and fluoropyrimidine

Scientific Title:Acronym

Phase 2 trial of TAS-102 with bevacizumab in patients with advanced/recurrent colorectal cancer who had previously received on standard therapies

Region

Japan


Condition

Condition

Colorectal Cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of combination TAS-102 plus Bevacizumab in patients with advanced/recurrent colorectal cancer who had previously received on oxaliplatin, irinotecan and fluoropyrimidine.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Disease control rate

Key secondary outcomes

Progression free survival
Overall survival
frequency and grade of adverse events


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

TAS-102(35mg/m2) is administered orally twice daily in 1-5days and 15-20 days and Bevacizumab(5mg/kg) is administered by injection in day 1 and day15. 1 cycle is 28days.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically proven adenocarcinoma of colon or rectum
2) 20-80 years old
3) Previously received at least
one prior regimens of standard chemotherapies including oxaliplatin, irinotecan and fluoropyrimidine
4) ECOG performance status of 0 or 1
5) At least one measurable lesion (RECIST 1.1)
6) Adequate organ function:
1.Leukocytes: 3,000-12,000/mm3
2.Neutrophil: >= 1,500/mm3
3.Platelets: >= 100,000/mm3
4.Serum total bilirubin: <= 1.5mg/dL
5.Serum AST, ALT: <= 100U/L (or 200U/L in cases after biliary drainage), ALT <= 100U/L (or 150U/L in cases liver metastasis)
6.Serum creatinine: <= 1.2mg/dL
7) Adequate oral intake
8) Life expectancy of 3 months
9) Written informed consent

Key exclusion criteria

1) Previously received TAS-102 or regorafenib
2) Serious drug allergy (excluding oxaliplatin)
3) Serious myelosuppression
4) Active infectious disease
5) Interstitial lung disease or pulmonary fibrosis
6) Watery diarrhea
7) Serious comorbid illness (intestinal paralysis, obstruction, uncontrolled diabetes, renal failure, liver failure, etc)
8) Other active malignancies
9) Pregnancy, breast feeding, or women who desire to preserve fecundity. Men who want his partner to be pregnant
10) Patients who were judged inappropriate for the entry to this study by the investigators

Target sample size

28


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Katsumata

Organization

Tokyo Medical University

Division name

Department of Gastrointestinal and Pediatric Surgery

Zip code


Address

6-7-1,Nishishinjuku,Shinjuku- ku,Tokyo,160-0023

TEL

03-3342-6111

Email

k-katsu@tokyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tetsuo Ishizaki

Organization

Tokyo Medical University

Division name

Department of Gastrointestinal and Pediatric Surgery

Zip code


Address

6-7-1,Nishishinjuku,Shinjuku- ku,Tokyo,160-0023

TEL

03-3342-6111

Homepage URL


Email

wbc15000@yahoo.co.jp


Sponsor or person

Institute

Tokyo Medical University
Department of Gastrointestinal and Pediatric Surgery

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

東京医科大学 消化器・小児外科学分野(東京都)
東京医科大学八王子医療センター(東京都)
戸田中央総合病院(埼玉県)
厚生中央病院(東京都)


Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 20 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2016 Year 03 Month 08 Day

Date of IRB


Anticipated trial start date

2016 Year 03 Month 08 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry

2021 Year 12 Month 31 Day

Date trial data considered complete

2022 Year 12 Month 31 Day

Date analysis concluded

2022 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 02 Month 08 Day

Last modified on

2017 Year 02 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029919


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name