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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: Rucaparib

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Hyogo
    • Akashi, Hyogo, Japan, 673-8558
      • Division of Medical Oncology, Hyogo Cancer Center
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Department of Gynecologic Oncology, Saitama Medical Univeristy international Medical Center
  • Tokyo
    • Tsukiji, Tokyo, Japan, 104-0045
      • Department of Breast and Medical Oncology, National Cancer Center Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Rucaparib monotherapy; 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.)	Drug: Rucaparib; Rucaparib will be administered twice daily; Other Names: CO-338

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Dose-limiting toxicities (DLTs) during Cycle 1 of treatment	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)
Peak Plasma Concentration [Cmax]	From enrollment to completion of Part I (up to 12 months)
Total Plasma Clearance [CI/F]	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)

Collaborators and Investigators

• Sponsor: zr Pharma & GmbH

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2018
• Primary Completion (Actual): June 18, 2019
• Study Completion (Actual): April 13, 2022

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: April 13, 2018
• First Posted (Actual): April 17, 2018

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; Rucaparib
• Other Study ID Numbers: CO-338-081

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No