A Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor

Advanced Solid Tumor Clinical Trial

Official title:

A Phase 1, Open-label, Safety and Pharmacokinetic Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03499444
• Other study ID #: CO-338-081
• Status: Completed
• Phase: Phase 1
• Start date: February 6, 2018
• Est. completion date: April 13, 2022

Study information

• Verified date: June 2023
• Source: zr Pharma & GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 13, 2022
• Est. primary completion date: June 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• Rucaparib
Rucaparib will be administered twice daily

Locations

Country	Name	City	State
Japan	Division of Medical Oncology, Hyogo Cancer Center	Akashi	Hyogo
Japan	Department of Gynecologic Oncology, Saitama Medical Univeristy international Medical Center	Hidaka	Saitama
Japan	Department of Breast and Medical Oncology, National Cancer Center Hospital	Tsukiji	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
zr Pharma & GmbH

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Number of participants with serious AEs as a measure of safety and tolerability		From enrollment to completion of Part I (up to 12 months)
Primary	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	Dose-limiting toxicities (DLTs) during Cycle 1 of treatment		From enrollment to completion of Part I (up to 12 months)
Secondary	Area under the plasma concentration versus time curve [AUC]		From enrollment to completion of Part I (up to 12 months)
Secondary	Peak Plasma Concentration [Cmax]		From enrollment to completion of Part I (up to 12 months)
Secondary	Total Plasma Clearance [CI/F]		From enrollment to completion of Part I (up to 12 months)
Secondary	Response to treatment according to RECIST Version 1.1		From enrollment to primary completion of study (up to 3 years)