Clinical trial · Interventional
Investigate the Safety and Tolerability of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies
A Phase I, Open-label Study to Assess the Safety and Tolerability of Doses of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies
NCT01813474CI-TRIAL-00031185completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this study will be to investigate the safety and tolerability of olaparib tablet when given orally to Japanese patients with advanced solid malignancies. In addition, the pharmacokinetic profile, MTD (if possible) and efficacy of olaparib will be investigated.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Malignancies | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| olaparib | Drug | Olaparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- olaparib tablet monotherapy
- description
- olaparib tablet
- interventionNames
- Drug: olaparib
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events
- timeFrame
- From the start dose to 30 days after the last dose of study drug
- description
- An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. This was recorded if it happend from the start dose to 30 days after the last of study drug.
Secondary outcomes (7)
- measure
- Number of Participants With Dose Limiting Toxicities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists. * Subjects who have overall good overall general condition. * Subjects who agree to hospitalisation from starting olaparib to multiple dose period at day 15. * Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status. * Subjects who have at least one lesion (measurable and/or non-measurable) that can be accurately assessed by CT/MRI at baseline and follow up visits Exclusion Criteria: * Subjects who received any previous treatment with a PARP (poly adenosine diphosphate-ribose polymerase) inhibitor, including olaparib. * Subjects receiving inhibitors of CYP3A4 (cytochrome P450 3A4). * Subjects with symptomatic uncontrolled brain metastases. * Subjects with myelodysplastic syndrome/acute myeloid leukaemia. * Subjects with a known hypersensitivity to olaparib or any of the excipients of the product.
References
Publications (0)
Data not yet available
No reference posted for this study.