Clinical trial NCT03499444: A Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor
Official title: A Phase 1, Open-label, Safety and Pharmacokinetic Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: pharmaand GmbH
Sponsor class: INDUSTRY
First posted: 2018-04-17
Enrollment: 29
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
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: Number of participants with worsening laboratory values as a measure of safety and tolerability
timeFrame: From enrollment to completion of Part I (up to 12 months)
Secondary outcomes:
measure: Dose-limiting toxicities (DLTs) during Cycle 1 of treatment
timeFrame: From enrollment to completion of Part I (up to 12 months)
measure: Area under the plasma concentration versus time curve [AUC]
timeFrame: From enrollment to completion of Part I (up to 12 months)
measure: Peak Plasma Concentration [Cmax]
timeFrame: From enrollment to completion of Part I (up to 12 months)
measure: Total Plasma Clearance [CI/F]
timeFrame: From enrollment to completion of Part I (up to 12 months)
measure: Response to treatment according to RECIST Version 1.1
timeFrame: From enrollment to primary completion of study (up to 3 years)
Other outcomes:
Locations:
city: Akashi
country: Japan
facility: Division of Medical Oncology, Hyogo Cancer Center
state: Hyogo
city: Hidaka
country: Japan
facility: Department of Gynecologic Oncology, Saitama Medical Univeristy international Medical Center
state: Saitama
city: Tsukiji
country: Japan
facility: Department of Breast and Medical Oncology, National Cancer Center Hospital
state: Tokyo
Study officials:
References: