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Completed

NCT Number: NCT03499444

A 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.

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Key information

Conditions

Advanced Solid Tumor

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Division of Medical Oncology, Hyogo Cancer Center, Akashi, Hyōgo, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rucaparib

Drug

Rucaparib will be administered twice daily

Other names: CO-338

Primary outcomes

  1. 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)

  2. Number of participants with serious AEs as a measure of safety and tolerability

    Time frame: From enrollment to completion of Part I (up to 12 months)

  3. Number of participants with worsening laboratory values as a measure of safety and tolerability

    Time frame: From enrollment to completion of Part I (up to 12 months)

Secondary outcomes

  1. Dose-limiting toxicities (DLTs) during Cycle 1 of treatment

    Time frame: From enrollment to completion of Part I (up to 12 months)

  2. Area under the plasma concentration versus time curve [AUC]

    Time frame: From enrollment to completion of Part I (up to 12 months)

  3. Peak Plasma Concentration [Cmax]

    Time frame: From enrollment to completion of Part I (up to 12 months)

  4. Total Plasma Clearance [CI/F]

    Time frame: From enrollment to completion of Part I (up to 12 months)

  5. Response to treatment according to RECIST Version 1.1

    Time frame: From enrollment to primary completion of study (up to 3 years)

Sponsors and collaborators

Lead sponsor

pharmaand GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2022
First posted
Apr 17, 2018
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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