Pediatric refractory solid tumors
Conditions
Interventions
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.
Sponsors
Tokyo Medical and Dental University
National Cancer Center Hospital University Hospital, Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLTs | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety: AEs 2. PK parameters | — |
Countries
Japan
Contacts
Public ContactMinoru Imai
Olaparib pediatric trial office Tokyo Medical and Dental University
Outcome results
None listed