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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031438
Receipt No. R000035879
Scientific Title A single-arm confirmatory trial of pazopanib in patients with paclitaxel-pretreated primary cutaneous angiosarcoma(JCOG1605, JCOG-PACS)
Date of disclosure of the study information 2018/02/23
Last modified on 2018/02/23

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Basic information
Public title A single-arm confirmatory trial of pazopanib in patients with paclitaxel-pretreated primary cutaneous angiosarcoma(JCOG1605, JCOG-PACS)
Acronym A single-arm confirmatory trial of pazopanib in patients with paclitaxel-pretreated primary cutaneous angiosarcoma(JCOG1605, JCOG-PACS)
Scientific Title A single-arm confirmatory trial of pazopanib in patients with paclitaxel-pretreated primary cutaneous angiosarcoma(JCOG1605, JCOG-PACS)
Scientific Title:Acronym A single-arm confirmatory trial of pazopanib in patients with paclitaxel-pretreated primary cutaneous angiosarcoma(JCOG1605, JCOG-PACS)
Region
Japan

Condition
Condition Primary cutaneous angiosarcoma which has become refractory or there was intolerance to paclitaxel
Classification by specialty
Dermatology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of pazopanib as the second line treatment in patients with primary cutaneous angiosarcoma which has become refractory or there was intolerance to paclitaxel
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Progression free survival(response evaluation: every 4 weeks)
Key secondary outcomes Overall survival, Response rate, Disease control rate, Adverse events, Sever 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 A: Pazopanib group(Pazopanib 800mg is taken orally once daily until disease recurrence or progression)
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically confirmed primary cutaneous angiosarcoma not associated with lymphedema or radiation.
2) Primary or metastatic lesions. (histological evaluation is not essential for metastatic lesions)
3) Absence of intracranial metastasis
4) Age >= 20 and =< 85
5) ECOG performance status of 0 or 1.
6) Past history of paclitaxel monotherapy as a first line treatment with or without combination of any local treatment (surgery and/or radiation therapy)
7) No past history of any systemic chemotherapy other than paclitaxel
8) Refractory disease or unable to tolerate paclitaxel
9) A Measurable lesion is not required
10) No prior use of antiangiogenic agents
11) Absense of non-healing wound
12) Adequate organ and marrow function as defined below within 14 days prior to enrollment:
a) Absolute neutrophil count >= 1,500 /mm3
b) Hemoglobin >= 9.0 g/dL
c) Platelets >= 10X104 /mm3
d) Total bilirubin =< 2.25 mg/dL
e) AST=< 75 U/L
f) Male:ALT=< 105 U/L, female: ALT=< 57.5 U/L
g) Renal function: serum creatinine =< 1.5 mg/dL, or, if >1.5 mg/dL, calculated creatinine clearance > 50 mL/min
h) PT-INR <= 1.38
i) APTT <= 44.4 sec
j) TSH: 0.5-4.5 microU/mL
k) FT3: 2.0-4.0 pg/mL
l) FT4: 0.9-1.8 ng/dL
m) Left ventricular ejection fraction >= 50%
n) Corrected QT interval <= 480 ms
o) Negative urinary protein, or, if not negative, 24-hour urinary protein excretion <=0.15g
13) Written informed consent
Key exclusion criteria 1) Synchronous or metachronous (within 3 years) malignancies except for carcinoma in situ or intramucosal tumors curatively treated with local therapy
2) Active infection requiring systemic therapy
3) Body temperature >= 38 degrees Celsius
4) Pregnant, possible pregnant, or lactating women. Within 28 days after childbirth. Men with favoring gestation of their partners.
5) Severe psychiatric disease
6) Patients who are receiving systemic administration of steroid or other immunosuppressants.
7) Patients with hypertension (>140 mmHg systolic and > 90 mmHg diastolic) that cannot be adequately controlled with antihypertensives.
8) Patients with heart disease as listed below within 6 months prior to enrollment:
a) Percutaneous transluminal coronary angioplasty
b) Myocardial infarction
c) Unstable angina pectoris
d) Coronary artery bypass grafting
e) Symptomatic peripheral arterial disease
f) Patients with cardiac insufficiency of NYHA class3 or 4
9) Patients with massive pleural effusion or paricardial effusion
10) Patients with interstitial lung disease
11) Patients with paralysis of intestine or ileus
12) Parients with active bleeding
13) Parients with cerebrovascular events within 6 months prior to enrollment
14) Parients with pulmonary enbolism within 6 months prior to enrollment
15) Parients with untreated deep vein thrombosis within 6 months prior to enrollment
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoya Yamazaki
Organization National Cancer Center Hospital, Japan
Division name Department of Dermatologic Oncology
Zip code
Address Tsukiji 5-1-1, Chuo-ku, Tokyo 1040045, Japan
TEL 03-3542-2511
Email nyamazak@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kohei Oashi
Organization JCOG1605 Coordinating Office
Division name Division of Dermatology, Saitama Cancer Center
Zip code
Address 780 Komuro, Ina, Kita-adachi-gun, Saitama 362-0806, Japan
TEL 048-722-1111
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 北海道大学病院(北海道)
旭川医科大学(北海道)
札幌医科大学(北海道)
筑波大学医学医療系(茨城県)
埼玉医科大学国際医療センター(埼玉県)
埼玉医科大学病院(埼玉県)
国立がん研究センター中央病院(東京都)
東京大学医学部(東京都)
新潟県立がんセンター新潟病院(新潟県)
富山県立中央病院(富山県)
信州大学医学部(長野県)
静岡県立静岡がんセンター(静岡県)
名古屋大学医学部(愛知県)
京都大学医学部附属病院(京都府)
大阪国際がんセンター(大阪府)
福岡大学医学部(福岡県)
九州大学病院(福岡県)
熊本大学医学部(熊本県)
国立病院機構鹿児島医療センター(鹿児島県)

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 23 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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 23 Day
Last follow-up date
2025 Year 08 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 23 Day
Last modified on
2018 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035879

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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