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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030603
Receipt No. R000034950
Scientific Title Phase II trial of docetaxel plus ramucirumab combination therapy in patients with advanced EGFR gene mutation positive advanced stage non-squamous cell nonsmall cell lung cancer (HSR 1701)
Date of disclosure of the study information 2018/01/04
Last modified on 2019/06/21

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Basic information
Public title Phase II trial of docetaxel plus ramucirumab combination therapy in patients with advanced EGFR gene mutation positive advanced stage non-squamous cell nonsmall cell lung cancer (HSR 1701)
Acronym Phase II trial of docetaxel plus ramucirumab combination therapy in patients with advanced EGFR gene mutation positive advanced stage non-squamous cell nonsmall cell lung cancer (HSR 1701)
Scientific Title Phase II trial of docetaxel plus ramucirumab combination therapy in patients with advanced EGFR gene mutation positive advanced stage non-squamous cell nonsmall cell lung cancer (HSR 1701)
Scientific Title:Acronym Phase II trial of docetaxel plus ramucirumab combination therapy in patients with advanced EGFR gene mutation positive advanced stage non-squamous cell nonsmall cell lung cancer (HSR 1701)
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 It is aimed to verify the effectiveness and safety of combination chemotherapy with ramcilmab and docetaxel in patients with EGFR gene mutation positive nonsquamous non-small cell lung cancer with a history of treatment with EGFR-TKI and platinum combination chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes progression-free survival from the start of treatment
Key secondary outcomes response rate, disease control rate, overall survival, safety

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 Docetaxel (60 mg / m 2, day 1) + Ramucirumab (10 mg/kg, day 1) and PEG-G-CSF(3.6 mg, day 2) every 3 weeks until progression or both docetaxel and rRamucirumab termination.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) 20 years old or older.
2) Histologically or pathologically proven non-squamous NSCLC with EGFR mutation.
3) Cases with a history of treatment with EGFR-TKI and platinum combination therapy.
4) Presence of measurable lesions on RECIST ver.1.1.
5) Eastern Cooperative Oncology Group (ECOG) performance status: 0-2.
6) Stage 3B, 4, or recurrence, two weeks or more have passed since the completion of radiotherapy.
7) Life expectancy of more than 3 months.
8) Written informed.
9) major organs are held by the examination value within 30 days and clinical examination at the start of treatment meets the following criteria
Neut >= 1,500/mm3
Hb >= 9.0 g/dL
CRE <= 1.5 mg/dL
T-bil <= 1.5 mg/dL
AST/ALT <= 100 IU/L (<= 200 IU/L by liver metastases)
Protein uria <= 1+
Key exclusion criteria 1) Diagnosed as squamous cell carcinoma
2) History of hemoptysis(=>2.5mL)
3) Bleeding diathesis or coagulopathy in the absence of therapeutic anticoagulation
4) With thromboembolism
5) Peptic ulcer, gastrointestinal perforation, intestinal diverticulitis, inflammatory bowel disease combined
6) Tumor invasion in the blood vessel.
7) Symptomatic brain metastasis.
8) Exposure of the tumor to the central airway
9) With third-space fluid need to be drained.
10) Active double cancers within 5 years(cured intraepithelial carcinoma and intramucosal carcinoma are not included).
11) With severe complications
Intestinal palsy, intestinal obstruction
Interstitial pneumonia or pulmonary fibrosis
Superior vena cava syndrome
Difficult-to-control diabetes, hypertension, liver disorder, angina pectoris, congestive heart failure and myocardial infarction within 3 months after onset
Cases with complications of severe infection or cases suspected of severe infection
Cases with complications that are deemed to cause serious obstruction to treatment enforcement
12)Anticoaglation with aspirin (> 325 mg / day) or clopidogrel (> 75 mg / day). Prophylactic use of anticoagulants is acceptable).
13)Pregnant or breastfeeding women. Willing to get pregnant. Severe psychological disease
14)Judgment to attending physician.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Takafumi
Middle name
Last name Suda
Organization Hamamatsu university school of medicine
Division name Second Division, Department of Internal Medicine
Zip code 431-3192
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka
TEL 053-435-2263
Email suda@hama-med.ac.jp

Public contact
Name of contact person
1st name Shogo
Middle name
Last name Sakurai
Organization Hamamatsu university school of medicine
Division name Second Division, Department of Internal Medicine
Zip code 431-3192
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka
TEL 053-435-2263
Homepage URL
Email sakushow@hama-med.ac.jp

Sponsor
Institute Second Division, Department of Internal Medicine, Hamamatsu university school of medicine
Institute
Department

Funding Source
Organization None
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 Hamamatsu university school of medicine Research cooperation section research support staff
Address Shizuoka Ken Hamamatsu city Handayama 1-20-1
Tel 053-435-2111
Email rinri@hama-med.ac.jp

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 浜松医科大学 第二内科 (静岡県)
磐田市立総合病院 呼吸器内科(静岡県)
静岡県立総合病院 呼吸器内科 (静岡県)
JA静岡厚生連遠州病院 呼吸器内科 (静岡県)
静岡赤十字病院 呼吸器内科 (静岡県)
静岡市立静岡病院 呼吸器内科 (静岡県)
静岡市立清水病院 呼吸器内科 (静岡県)
聖隷三方原病院 呼吸器内科 (静岡県)
聖隷浜松病院 呼吸器内科 (静岡県)
独立行政法人国立医療機構 天竜病院 呼吸器・アレルギー科(静岡県)
浜松赤十字病院 呼吸器内科 (静岡県)
浜松労災病院 呼吸器内科 (静岡県)
浜松医療センター 呼吸器内科(静岡県)
藤枝市立総合病院 呼吸器内科(静岡県)
静岡済生会病院 呼吸器内科(静岡県)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 04 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
2017 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 28 Day
Last modified on
2019 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034950

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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