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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025521
Receipt No. R000028971
Scientific Title Phase I Clinical Study of Oral Olaparib in Pediatric Patients with Refractory Solid Tumors
Date of disclosure of the study information 2017/01/04
Last modified on 2019/07/08

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Basic information
Public title Phase I Clinical Study of Oral Olaparib in Pediatric Patients with Refractory Solid Tumors
Acronym Phase I Clinical Study of Oral Olaparib in Pediatric Patients with Refractory Solid Tumors
Scientific Title Phase I Clinical Study of Oral Olaparib in Pediatric Patients with Refractory Solid Tumors
Scientific Title:Acronym Phase I Clinical Study of Oral Olaparib in Pediatric Patients with Refractory Solid Tumors
Region
Japan

Condition
Condition Pediatric refractory solid tumors
Classification by specialty
Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate safety and tolerability of olaparib in pediatric patients with refractory solid tumors and determine the recommended dose.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes DLTs
Key secondary outcomes 1. Safety: AEs
2. PK parameters

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 Olaparib tablets

Olaparib will be administered orally twice daily, 125mg/m2, 250mg/m2 or 375mg/m2, until any discontinuation criteria has been met. A treatment cycle will be 28 days.
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
3 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria (1)The subject's legally acceptable representative has provided written informed consent of the study treatment and assessments, and are willing and able to comply with the procedure.
(2) Age of 3-18 years at the time of informed consent.
(3)Patients with pediatric refractory solid tumors, which remain after 2 chemotherapy regimens and are classified as the category IV-XII of International Classification of Childhood Cancer, Third Edition.
(4)Meet one of criteria following;
Tumor can be identified on CT/MRI
And/or by histology or cytology.
(5)Patients must have a life expectancy more than 2 months after the planned starting date of the study treatment.
(6)Patients must have normal organ and bone marrow function measured within 14 days prior to enrollment.
(7)Lansky play-performance scale (age <16) or Karnofsky scale (age >= 16) > 70
(8)Non-childbearing status for women of childbearing potential (after the menarche); negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.
(9)Able to swallow tablets 6 mm in diameter.
Key exclusion criteria (1)Involvement in the planning and/or conduct of the study.
(2)Previous enrolment and administration of olaprib in the past study.
(3)Any previous treatment with PARP inhibitor, including olaparib.
(4)Other malignancy in the past.
(5)Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 21 days prior to study treatment.
(6)Patients with symptomatic uncontrolled brain metastases.
(7)Patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
(8)BSA <0.4 m2 at enrollment.
(9)Administration of other study drugs within 21 days prior enrollment.
(10)Concomitant use of known strong CYP3A inhibitors. The required washout period prior to starting olaparib is 14 days.
(11)Concomitant use of known CYP3A inducers. The required washout period prior to starting olaparib is 21 days. See details at restriction.
(12)Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous therapy.
(13)Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
(14)Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
(15)Breast feeding women.
(16)Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)
(17)Patients with known active hepatitis (i.e. Hepatitis B or C)
(18)Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
(19)Patients who have undergone auto hematopoietic stem cell transplantation (HSCT) within 112 days (4 months) prior to enrollment
(20)Patients who have previous allogenic hematopoietic stem cell transplantation (HSCT)
(21)Are otherwise inappropriate for this study in the investigator's or subinvestigator's opinion.
Target sample size 18

Research contact person
Name of lead principal investigator
1st name Masatoshi
Middle name
Last name Takagi
Organization Tokyo Medical and Dental University Hospital
Division name Pediatrics
Zip code 113-8519
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5249
Email m.takagi.ped@tmd.ac.jp

Public contact
Name of contact person
1st name Minoru
Middle name
Last name Imai
Organization Olaparib pediatric trial office
Division name Tokyo Medical and Dental University
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-4730
Homepage URL
Email olp-office@c-ctd.co.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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

Other related organizations
Co-sponsor National Cancer Center Hospital
University Hospital, Kyoto Prefectural University of Medicine
Name of secondary funder(s) AstraZeneca K.K.

IRB Contact (For public release)
Organization Tokyo Medical and Dental University Hospital of Medicine, Institutional Review Board
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel 03-5803-5612
Email tiken.crc@tmd.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 東京医科歯科大学医学部附属病院(東京都)
国立がん研究センター中央病院(東京都)
京都府立医科大学附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2017 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 Open public recruiting
Date of protocol fixation
2016 Year 12 Month 01 Day
Date of IRB
2016 Year 12 Month 26 Day
Anticipated trial start date
2017 Year 07 Month 24 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 05 Month 31 Day
Date trial data considered complete
2020 Year 08 Month 31 Day
Date analysis concluded
2020 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 04 Day
Last modified on
2019 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028971

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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