UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025901
Receipt No. R000029596
Official scientific title of the study Placebo-controlled randomized, double-blind study of zaltoprofen for patients with diffuse type tenosynovial giant cell tumor (Pigmented Villonodular Synovitis) and unresectable localized tenosynovial giant cell tumor (tendon sheath giant cell tumor) (Phase II study)
Date of disclosure of the study information 2017/04/01
Last modified on 2018/04/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Placebo-controlled randomized, double-blind study of zaltoprofen for patients with diffuse type tenosynovial giant cell tumor (Pigmented Villonodular Synovitis) and unresectable localized tenosynovial giant cell tumor (tendon sheath giant cell tumor) (Phase II study)
Title of the study (Brief title) Placebo-controlled randomized, double-blind Phase II study of zaltoprofen for patients with diffuse type tenosynovial giant cell tumor and unresectable localized tenosynovial giant cell tumor
Region
Japan

Condition
Condition diffuse type tenosynovial giant cell tumor (Pigmented Villonodular Synovitis) and localized tenosynovial giant cell tumor (tendon sheath giant cell tumor)
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of efficacy and safety of zaltoprofen for for patients with diffuse type tenosynovial giant cell tumor (Pigmented Villonodular Synovitis) and unresectable localized tenosynovial giant cell tumor (tendon sheath giant cell tumor)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression-free rate at 48 weeks after drug administration ((Definition of exacerbation is "serious event requiring surgical intervention")
Evaluate as exacerbation if it falls under any one or more of the following serious events requiring surgical intervention. If (1) and (2) are evaluated every 4 weeks and judged as exacerbation twice in succession, if (3), (4), (5) are evaluated once every 12 weeks and evaluated once Judgment of exacerbation.
1) Increase in joint perimeter diameter by 2 cm or more with respect to baseline (knee is 1 cm above knee patella, ankle joint is measuring using figure-eight method). If there is fluid accumulation, puncture to check for the presence or absence of hematoma, increase in joint periphery diameter due to edema is not exacerbated.
(2) The range of motion of the joint (active motion) is reduced by 20% or more with respect to the baseline (calculated by averaging three measurements with a goniometer)
(3) Invasion of 5 mm or more of bone / cartilage erosion or new lesion of bone / cartilage erosion of 5 mm or more compared with baseline by CT or MRI
(4) X-ray photography at standing position, disappearance of joint space
(5) Increase of target lesion by 20% or more by RECIST
(6) Other cases, surgery was performed for a specific reason
Key secondary outcomes (1) Progression-free rate (24 weeks and 48 weeks): Percentage of cases of CR, PR, and SD. (However, when CR and PR keep the same condition for more than 4 weeks)
(2) Maximum Standarized Uptake Value (SUV) change rate by FDG-PET
(3) Evaluation of affected limb function (baseline, 24 weeks, 48 weeks): The Japanese Orthopedic Association score, MSTS score
(4) Percentage of cases in which clinical benefit about pain, range of motion of joint, joint function compared with baseline is observed at 24 weeks and 48 weeks (judgment by investigator or clinical trial physician)
(5) Types, incidence and severity of adverse events and abnormal laboratory data (graded using CTCAE v4.0), The severity and the relationship with the investigational drug will be evaluated

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In the zaltoprofen group, 2 tablets of zaltoprofen (80 mg) 3 times a day, 2 placebo tablets in placebo group orally 3 times a day with water of 1 cup or more (about 150 mL) or more after oral administration .
Gastric mucosa protective agent is orally administered in regular dosage and dose as a concomitant medicine.
Interventions/Control_2 48 weeks administration
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
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients who satisfy all of the following conditions are included.
(1) Patients who sufficiently are explained the research purpose, interests and disadvantages before starting the examination about the clinical trial, understand it, and obtained written informed consent. No substitute is allowed.
(2) Patients who are diagnosed as diffuse type tendinous synovial giant cell tumor (pigmented chorionic synovitis) or unresectable localized tendonous synovial giant cell tumor occurred in the knee joint or ankle by radiological findings and pathological findings
(3) Patient with measurable lesion based on RECISTv 1.1 with at least one knee joint or ankle joint.
(4) Patients who keep joint space in the knee joint or ankle joint in standing X-ray imaging.
(5) Patients aged 20 years or older and under 70 years old at the time of acquisition.
(6) In the case of a pregnant woman, a patient whose pregnancy test to be conducted during the screening period is negative.
Key exclusion criteria The following patients must be excluded.
(1) Patients with severe heart disease, renal disease, respiratory disease, blood disease, diabetes, coagulopathy, hepatic injury, renal disorder
(2) Patients with gastlic ulcer.
(3) Patient with aspirin asthma or a history of aspirin.
(4) Patients who have had a history of allergic symptoms such as itching and rash, taking zaltoprofen (Soleton tablet 80, Peon tablet 80 etc) before.
(5) Hypersensitivity to additives of zaltoprofen (lactose hydrate, corn starch, cellulose, silicic anhydride, hydroxypropyl cellulose, carmellose Ca, stearic acid Mg, polysorbate 80, hypromellose, titanium oxide, talc, carnauba wax) Patient with a history of disease.
(6) Patients who are administered any of the following agents within 14 days prior to enrollment: tyrosine kinase inhibitors, nonsteroidal anti-inflammatory drugs, thiazolidine derivatives and drug with thiazolysine ring
(7) Patients who have a limited active range of motion more than 20% with respect to the healthy side
(8) Patients whose joint space has disappeared by standing position X-ray photography.
(9) Patients who are inappropriate for MRI, PET, etc. examination.
(10) Patients who are pregnant or lactating. Or patients who do not agree to contraception from the final administration of the study drug to 90 days after.
(11) Patients who are difficult to take oral medicine.
(12) Patients who were using other investigational drugs or using the investigational device within 3 months prior to the study drug administration.
(13) A patient whose investigator or clinical trial doctor judged unsuitable for participation in this trial due to other reasons.
Target sample size 40

Research contact person
Name of lead principal investigator Hiroyuki Tsuchiya
Organization Kanazawa University Hospital
Division name Orthopaedic surgery
Address 13-1 Takaramachi, Kanazawa, Japan
TEL 076-265-2000
Email tsuchi@med.kanazawa-u.ac.jp

Public contact
Name of contact person Akihiko Takeuchi
Organization Kanazawa University
Division name Orthopaedic Surgery
Address 13-1 Takaramachi, Kanazawa, Japan
TEL 076-265-2000
Homepage URL
Email a_take@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Developmen
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Asahikawa Medical University
National Cancer Center Hospital
Fukui Univeristy
Nagoya City University
Nagoya University
Mie University
Kyoto Prefectural University
Osaka City University
Okayama University
Kyusyu University
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 01 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 01 Month 22 Day
Anticipated trial start date
2017 Year 04 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2017 Year 01 Month 30 Day
Last modified on
2018 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029596

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.