Advanced Solid Tumor
Conditions
Brief summary
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.
Interventions
DRUGRucaparib
Rucaparib will be administered twice daily
Sponsors
pharmaand GmbH
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related Adverse Events (AEs) as assessed by CTCAE v4.03 as a measure of safety and tolerability | From enrollment to completion of Part I (up to 12 months) |
| Number of participants with serious AEs as a measure of safety and tolerability | From enrollment to completion of Part I (up to 12 months) |
| Number of participants with worsening laboratory values as a measure of safety and tolerability | From enrollment to completion of Part I (up to 12 months) |
Secondary
| Measure | Time frame |
|---|---|
| Total Plasma Clearance [CI/F] | From enrollment to completion of Part I (up to 12 months) |
| Area under the plasma concentration versus time curve [AUC] | From enrollment to completion of Part I (up to 12 months) |
| Response to treatment according to RECIST Version 1.1 | From enrollment to primary completion of study (up to 3 years) |
| Dose-limiting toxicities (DLTs) during Cycle 1 of treatment | From enrollment to completion of Part I (up to 12 months) |
| Peak Plasma Concentration [Cmax] | From enrollment to completion of Part I (up to 12 months) |
Countries
Japan
Outcome results
None listed