UMIN-CTR Clinical Trial

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	office.innv@tmd.ac.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	15
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	Completed
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 12 Month 31 Day
Date of closure to data entry	2021 Year 02 Month 28 Day
Date trial data considered complete	2021 Year 03 Month 15 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 01 Month 04 Day
Last modified on	2021 Year 06 Month 28 Day

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