Clinical Trials /

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

NCT03499444

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: CO-338-081
  • NCT ID: NCT03499444

Conditions

  • Advanced Solid Tumor

Interventions

DrugSynonymsArms
RucaparibCO-338Oral Rucaparib monotherapy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Oral Rucaparib monotherapyExperimentalPart I: Dose Escalation, Part II: Dose Expansion (Additional patients will be enrolled at the recommended dose as defined in Part I of the study.)
  • Rucaparib

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with treatment-related Adverse Events (AEs) as assessed by CTCAE v4.03 as a measure of safety and tolerability
Time Frame:From enrollment to completion of Part I (up to 12 months)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Dose-limiting toxicities (DLTs) during Cycle 1 of treatment
Time Frame:From enrollment to completion of Part I (up to 12 months)
Safety Issue:
Description:
Measure:Area under the plasma concentration versus time curve [AUC]
Time Frame:From enrollment to completion of Part I (up to 12 months)
Safety Issue:
Description:
Measure:Peak Plasma Concentration [Cmax]
Time Frame:From enrollment to completion of Part I (up to 12 months)
Safety Issue:
Description:
Measure:Total Plasma Clearance [CI/F]
Time Frame:From enrollment to completion of Part I (up to 12 months)
Safety Issue:
Description:
Measure:Response to treatment according to RECIST Version 1.1
Time Frame:From enrollment to primary completion of study (up to 3 years)
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Clovis Oncology, Inc.

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