Clinical trial · Interventional
A Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor
A Phase 1, Open-label, Safety and Pharmacokinetic Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor
- 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)
This is a Phase 1 open-label, dose-escalation, safety and pharmacokinetic study of rucaparib administered twice daily (BID) to Japanese patients with a solid tumor who have failed previous standard treatment for their cancer. A recommended dose of rucaparib for Japanese patients will be determined in a dose-escalation portion and then further evaluated in a dose-expansion portion of the study.
Conditions
Conditions (1)
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 Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rucaparib | Drug | Rucaparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oral Rucaparib monotherapy
- description
- Part I: Dose Escalation, Part II: Dose Expansion (Additional patients will be enrolled at the recommended dose as defined in Part I of the study.)
- interventionNames
- Drug: Rucaparib
Primary outcomes (3)
- measure
- Number of participants with treatment-related Adverse Events (AEs) as assessed by CTCAE v4.03 as a measure of safety and tolerability
- timeFrame
- From enrollment to completion of Part I (up to 12 months)
- measure
- Number of participants with serious AEs as a measure of safety and tolerability
- timeFrame
- From enrollment to completion of Part I (up to 12 months)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Be 20 years of age at the time the informed consent form is signed and of Japanese ethnicity (ie, both parents are native Japanese and were born in Japan). * Have a solid tumor that has progressed on standard treatment: * For patients enrolled in the dose-escalation portion, has confirmed solid tumor that is locally recurrent or metastatic * For patients enrolled in the dose-expansion portion, has high-grade serous ovarian cancer, or BRCA 1/2 mutated breast cancer, or other solid tumor with BRCA 1/2 or related gene mutation * Have to have evaluable disease (i.e. disease can be followed on scans.) * Be willing and able to fast for at least 14 hours Exclusion Criteria: * Active second malignancy * Prior treatment with any PARP inhibitor * Symptomatic and/or untreated CNS metastases * Women who are breastfeeding or pregnant * Pre-existing duodenal stent and/or any gastrointestinal disorder that would interfere with drug absorption * Requires regular blood transfusions
References
Publications (0)
Data not yet available