Drug-Drug Interaction Study of Rucaparib, Rosuvastatin and Oral Contraceptives

June 7, 2023 updated by: zr Pharma & GmbH

A Phase 1, Open-label, Drug-drug-interaction Study to Determine the Effect of Rucaparib on the Pharmacokinetics of Oral Rosuvastatin (Arm A) and Oral Contraceptives (Ethinylestradiol and Levonorgestrel) (Arm B) in Patients With Advanced Solid Tumors

This study will investigate the drug-drug interactions (DDIs) between rucaparib and oral rosuvastatin (Arm A), and between rucaparib and oral ethinylestradiol and levonorgestrel (Arm B), with rucaparib as a perpetrator.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 1, open-label, drug-drug-interaction (DDI) study in patients with advanced solid tumor. In Part I, the effects of rucaparib (600 mg twice daily [BID]) on the PK of oral rosuvastatin (Arm A) and the combined oral contraceptives (ethinylestradiol and levonorgestrel; Arm B) will be assessed.

Part I: patients will receive single oral doses of rosuvastatin or oral contraceptives (according to assigned arm) on Day 1 and Day 19. Continuous treatment with rucaparib at 600 mg BID will commence on Day 5 and continue until the end of Part I (Day 23).

Part II (optional): treatment with rucaparib in 28-day cycles may continue (at the discretion of the Investigator) until progression of disease, unacceptable toxicity, or other reason for discontinuation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1076
        • PRA Magyarország Fázis I-es Klinikai Farmakológiai Vizsgálóhely FMC Dialízis Központ, II. em.
  • Poland
      • Biała Podlaska, Poland, 21-500
        • Wojewódzki Szpital Specjalistyczny W Białej Podlaskiej
      • Józefów, Poland, 05-410
        • BioVirtus Centrum Medyczne
      • Kraków, Poland, 31-752
        • Ujastek Sp. z o.o. Centrum medyczne
      • Poznań, Poland, 60-693
        • Med Polonia Sp. z o.o.
      • Warszawa, Poland, 01-401
        • Zdrowie Kobiety Centrum Leczniczo-Rehabilitacyjne i Medycyny Pracy ATTIS Sp. z o.o., Zakład Onkologii Kobiecej
  • Slovakia
      • Bratislava, Slovakia, 831 01
        • Summit Clinical Research s.r.o.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria (All patients):

  • Willing to sign the ICF and to comply with the study restrictions
  • Body mass index (BMI) 18.0 to 35.0 kg/m2
  • Histologically or cytologically confirmed advanced solid tumor
  • Patients who, in the opinion of the Investigator, could potentially benefit from treatment with rucaparib
  • ECOG performance status less than or equal to 1
  • Adequate organ function

Inclusion Criteria (Arm A):

- Male or female patients ≥ 18 years of age

Inclusion Criteria (Arm B):

- Female patients ≥ 18 years of age

Exclusion Criteria (All patients):

  • Specific cancer treatments within 14 days prior to Day 1
  • Arterial or venous thrombi (including cerebrovascular accident), myocardial infarction, admission for unstable angina, acute coronary syndrome, cardiac angioplasty, stenting, or poorly controlled hypertension within the last 3 months prior to screening
  • Pre-existing duodenal stent, recent or existing bowel obstruction
  • Untreated or symptomatic central nervous system (CNS) metastases. Patients with treated asymptomatic CNS metastases are eligible
  • Known HIV or AIDS-related illness, acute or history of chronic hepatitis B or C
  • Female patients who are pregnant or breastfeeding
  • Participation in another investigational drug trial within 30 days prior to Day 1 or exposure to more than 3 new investigational agents within 12 months prior to Day 1
  • Presence of active infection requiring antibiotics
  • Active second malignancy
  • History of drug abuse (including alcohol)

Exclusion Criteria (Arm A):

  • Current use of rosuvastatin or any other statin
  • History of hypersensitivity to rosuvastatin
  • Current, or history of, clinically significant myopathy

Exclusion Criteria (Arm B):

  • Current use of any 1 of the contraceptive drugs or previous contraceptive implants or depot injections, which may still be clinically effective
  • History of hypersensitivity to ethinylestradiol or levonorgestrel

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Arm A - rucaparib and oral rosuvastatin
Drug: Rucaparib
Rucaparib 600 mg BID commencing on Day 5 until Day 23.
Other Names:
  • Rubraca
Drug: Rosuvastatin
Single dose of 20mg oral rosuvastatin on Day 1 and Day 19 only.
Other Names:
  • Crestor
Other: Arm B - rucaparib and oral contraceptives
Drug: Rucaparib
Rucaparib 600 mg BID commencing on Day 5 until Day 23.
Other Names:
  • Rubraca
Drug: Oral Contraceptives
Single dose of combined oral contraceptive (30 μg ethinylestradiol and 150 μg levonorgestrel) on Day 1 and Day 19 only.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.
Time Frame: Day 1 to Day 23
Maximum plasma concentration (Cmax)
Day 1 to Day 23
PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.
Time Frame: Day 1 to Day 23
Area under the concentration-time curve (AUC) from time zero up to the last time point with a quantifiable concentration (AUC0-last)
Day 1 to Day 23
PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.
Time Frame: Day 1 to Day 23
AUC up to time infinity, with extrapolation of the terminal phase (AUC0-inf)
Day 1 to Day 23

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events [Safety and Tolerability]
Time Frame: From Day 1 to last patient visit in Part II (approximately 2 years)
From Day 1 to last patient visit in Part II (approximately 2 years)
Incidence of clinical laboratory abnormalities [Safety and Tolerability]
Time Frame: From Day 1 to last patient visit in Part II (approximately 2 years)
From Day 1 to last patient visit in Part II (approximately 2 years)
Incidence of dose modifications [Safety and Tolerability]
Time Frame: From Day 1 to last patient visit in Part II (approximately 2 years)
From Day 1 to last patient visit in Part II (approximately 2 years)
PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.
Time Frame: Day 1 to Day 23
Terminal half-life (t1/2)
Day 1 to Day 23
PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.
Time Frame: Day 1 to Day 23
Time to occurrence of Cmax (tmax)
Day 1 to Day 23
PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.
Time Frame: Day 1 to Day 23
Apparent total clearance of drug after oral administration (CL/F)
Day 1 to Day 23
PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.
Time Frame: Day 1 to Day 23
Apparent volume of distribution during terminal phase (Vz/F)
Day 1 to Day 23
The following secondary PK parameter will be calculated for rucaparib.
Time Frame: Day 1 to Day 23
Trough plasma concentration (Cmin)
Day 1 to Day 23

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
zr Pharma & GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 6, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 9, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CO-338-095

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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