UMIN-CTR Clinical Trial

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

Primary cutaneous angiosarcoma which has become refractory or there was intolerance to paclitaxel

Classification by specialty

Dermatology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

National Cancer Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2018

Year

02

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

02

Month

23

Day

Last modified on

2018

Year

02

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035879