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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499444
Recruitment Status : Active, not recruiting
First Posted : April 17, 2018
Last Update Posted : August 11, 2021
Sponsor:
Information provided by (Responsible Party):
Clovis Oncology, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: Rucaparib Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Safety and Pharmacokinetic Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor
Actual Study Start Date : February 6, 2018
Actual Primary Completion Date : June 18, 2019
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Rucaparib

Arms and Interventions
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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 Name: CO-338


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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) ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499444


Locations
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Japan
Division of Medical Oncology, Hyogo Cancer Center
Akashi, Hyogo, Japan, 673-8558
Department of Gynecologic Oncology, Saitama Medical Univeristy international Medical Center
Hidaka, Saitama, Japan, 350-1298
Department of Breast and Medical Oncology, National Cancer Center Hospital
Tsukiji, Tokyo, Japan, 104-0045
Sponsors and Collaborators
Clovis Oncology, Inc.
More Information
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Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT03499444    
Other Study ID Numbers: CO-338-081
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Rucaparib
Poly(ADP-ribose) Polymerase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents