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

Phase 1

Completed

• Conditions: Advanced Solid Tumor
• Interventions: Drug: Rucaparib

• Registration Number: NCT03499444
• Lead Sponsor: pharmaand GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-06
• Study First Submitted: 2018-03-26
• Study First Submitted QC: 2018-04-13
• Study First Posted: 2018-04-17
• Primary Completion: 2019-06-18
• Study Completion: 2022-04-13
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Oral Rucaparib monotherapy	Rucaparib	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.)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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)
Area under the plasma concentration versus time curve [AUC]	From enrollment to completion of Part I (up to 12 months)

Trial Locations

Locations (3)

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, Japan

Division of Medical Oncology, Hyogo Cancer Center; 🇯🇵 Akashi, Hyogo, Japan