UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019876 |
|---|---|
| Receipt number | R000022954 |
| Scientific Title | A phase I/II study for the safety and efficacy of Panitumumab in combination with TAS-102 for patients with RAS wild-type metastatic colorectal cancer refractory to standard chemotherapy |
| Date of disclosure of the study information | 2015/11/20 |
| Last modified on | 2019/05/23 15:06:26 |
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Basic information
Public title
A phase I/II study for the safety and efficacy of Panitumumab in combination with TAS-102 for patients with RAS wild-type metastatic colorectal cancer refractory to standard chemotherapy
Acronym
A phase I/II study for the safety and efficacy of Panitumumab in combination with TAS-102 for patients with metastatic colorectal cancer (APOLLON study)
Scientific Title
A phase I/II study for the safety and efficacy of Panitumumab in combination with TAS-102 for patients with RAS wild-type metastatic colorectal cancer refractory to standard chemotherapy
Scientific Title:Acronym
A phase I/II study for the safety and efficacy of Panitumumab in combination with TAS-102 for patients with metastatic colorectal cancer (APOLLON study)
Region
| Japan |
Condition
Condition
unresectable advanced colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase I part: To judge the move to next cohort with evaluating the safety and tolerability based on DLT ratio.
Phase II part: Progression free survival rate at 6 months PFS. The period will be determined from the day of enrollment.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I: DLT rate (1st course: 4 weeks)
Phase II: PFS rate at 6 months
Key secondary outcomes
OS: Overall survival
PFS: Progression free survival
RR: Response rate
DOR: Duration of response
DCR: Disease control rate
TTF: Time to treatment failure
<Safety>Adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Panitumumab+TAS-102
-Panitumumab 6mg/kg/ q2w
-TAS-102 35mg/m2 (Day1-5, Day8-12)
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Investigator and subinvestigator judge a candidate is understand clinical trial and comply this protocol.
(2)Patients who have given written consent to take part in the study after detailed explanation of the study prior to enrollment
(3)Aged 20 to 75 years at the time of informed consent
(4)Patients with unresectable adenocarcinoma originating in the large intestine (excluding carcinoma of the appendix and anal canal cancer)
(5)Patients with lesion(s) that can be evaluated. It is not essential to be evaluated the tumor according to the RECIST ver. 1.1.
(6)Patients who have received chemotherapies for metastatic colorectal cancer and are refractory to or failing those chemotherapies* including; fluoropyrimidines, irinotecan, oxaliplatin, and an anti-vascular endothelial growth factor (VEGF) agent.
(7)Patients classified as KRAS/NRAS wild-type by KRAS/NRAS testing.
(8)Patients are able to take medications orally.
(9)Patients who satisfy the following criteria for the major organ function in tests performed within 14 days prior to enrollment
Neutrophil count 1500/microL
Platelet count 100000/microL
Hemoglobin 8.0 g/dL
Total bilirubin 1.5 mg/dL
AST 100 IU/L ( 200 IU/L if liver metastases are present)
ALT 100 IU/L ( 200 IU/L if liver metastases are present)
Serum creatinine 1.5 mg/dL
(10)ECOG performance status (PS) of 0 or 1
(11)Life expectancy of 3 months (90 days) or more after enrollment
Key exclusion criteria
(1)Has received anti-EGFR antibodies (cetuximab or panitumumab), regorafenib, or TAS-102.
(2)Has had treatment with radiotherapy and/or chemotherapy within 2 weeks (14 days) prior to study drug administration (except for limited field radiation in order to rescue of pain).
(3)Known brain metastasis or strongly suspected of brain metastasis
(4)Synchronous cancers or metachronous cancers with a disease-free period of 5 years (excluding colorectal cancer) excluding mucosal cancers cured or be possibly cured by regional resection (esophageal, stomach, and cervical cancer, non-melanoma skin cancer, bladder cancer, etc.).
(5)Body cavity fluid that requires treatment (pleural effusion, ascites, pericardial effusion, etc.)
(6)Patients who do not want to use contraception to prevent pregnancy, and women who are pregnant or breast-feeding, or test positive for pregnancy
(7)Any investigational agent received within prior 4 weeks (28 days).
(8)Disease requiring systemic steroids for treatment (excluding topical steroids)
(9)History or obvious and extensive CT findings of interstitial pulmonary disease (interstitial pneumonia, pulmonary fibrosis, etc.)
(10)Intestinal paralysis, gastrointestinal obstruction, or uncontrollable diarrhoea (incapacitating symptoms despite adequate treatment.
(11)Serious drug hypersensitivity (without allergy to oxaliplatin)
(12)Local or systemic active infection requiring treatment, or fever indicating infection
(13)NYHA class II or higher heart failure or serious heart disease
(14)Active hepatitis B
(15)Known HIV infection
(16)Peripheral neuropathy of Grade 2 or greater by CTCAE (Japanese edition JCOG version 4.03)
(17)Known BRAF mutation
(18)Other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kensei Yamaguchi/Takeshi Kato |
Organization
Cancer Institute Hospital/National Hospital Organization Osaka National Hospital
Division name
Gastroenterological medicine/Surgery
Zip code
Address
3-8-31 Ariake, Koto-ku, Tokyo /2-1-14, Hoenzaka, Chuo-ku, Osaka City
TEL
0120-086723
apollon@medical-bs24.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Contact for Clinical Trial Information |
Organization
Takeda Pharmaceutical Company Limited
Division name
Contact for Clinical Trial Information
Zip code
Address
12-10 Nihonbashi 2-chome Chuo-ku Tokyo Japan
TEL
0120-086723
Homepage URL
apollon@medical-bs24.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT02613221
Org. issuing International ID_1
A service of the U.S. National Institutes of Health
Study ID_2
JapicCTI-153076
Org. issuing International ID_2
Japan Pharmaceutical Information Center
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 11 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 20 | Day |
Last modified on
| 2019 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022954
