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

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ClinicalTrials.gov Identifier: NCT03499444
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Clovis Oncology, Inc.

Tracking Information
First Submitted Date  ICMJE March 26, 2018
First Posted Date  ICMJE April 17, 2018
Last Update Posted Date August 30, 2019
Actual Study Start Date  ICMJE February 6, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
  • 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) ]
  • 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) ]
  • 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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03499444 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
  • Dose-limiting toxicities (DLTs) during Cycle 1 of treatment [ Time Frame: From enrollment to completion of Part I (up to 12 months) ]
  • Area under the plasma concentration versus time curve [AUC] [ Time Frame: From enrollment to completion of Part I (up to 12 months) ]
  • Peak Plasma Concentration [Cmax] [ Time Frame: From enrollment to completion of Part I (up to 12 months) ]
  • Total Plasma Clearance [CI/F] [ Time Frame: From enrollment to completion of Part I (up to 12 months) ]
  • Response to treatment according to RECIST Version 1.1 [ Time Frame: From enrollment to primary completion of study (up to 3 years) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor
Official Title  ICMJE A Phase 1, Open-label, Safety and Pharmacokinetic Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumor
Intervention  ICMJE Drug: Rucaparib
Rucaparib will be administered twice daily
Other Name: CO-338
Study Arms  ICMJE 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.)
Intervention: Drug: Rucaparib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 13, 2018)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clovis Oncology Clinical Trial Information 1-855-262-3040 (USA) clovistrials@emergingmed.com
Contact: Clovis Oncology Clinical Trial infomration +1-303-625-5160 (ex-USA) clovistrials@emergingmed.com
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03499444
Other Study ID Numbers  ICMJE CO-338-081
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clovis Oncology, Inc.
Study Sponsor  ICMJE Clovis Oncology, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Clovis Oncology, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP