UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025521 |
|---|---|
| Receipt number | 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 | 2021/06/28 17:11:32 |
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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
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
office.innv@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028971
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