NCT03954366

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2019

Typical duration for phase_1

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

April 25, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 17, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2021

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

April 2, 2019

Last Update Submit

June 7, 2023

Conditions

Neoplasms

Keywords

rucaparibCO-338ClovisClovis OncologyPARP InhibitorDrug-drug Interaction

Outcome Measures

Primary Outcomes (3)

  • PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.

    Maximum plasma concentration (Cmax)

    Day 1 to Day 23

  • PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.

    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.

    AUC up to time infinity, with extrapolation of the terminal phase (AUC0-inf)

    Day 1 to Day 23

Secondary Outcomes (8)

  • PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.

    Day 1 to Day 23

  • PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.

    Day 1 to Day 23

  • PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.

    Day 1 to Day 23

  • PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.

    Day 1 to Day 23

  • The following secondary PK parameter will be calculated for rucaparib.

    Day 1 to Day 23

  • +3 more secondary outcomes

Study Arms (2)

Arm A - rucaparib and oral rosuvastatin

OTHER
Drug: RucaparibDrug: Rosuvastatin

Arm B - rucaparib and oral contraceptives

OTHER
Drug: RucaparibDrug: Oral Contraceptives

Interventions

RucaparibDRUG

Rucaparib 600 mg BID commencing on Day 5 until Day 23.

Also known as: Rubraca
Arm A - rucaparib and oral rosuvastatinArm B - rucaparib and oral contraceptives
RosuvastatinDRUG

Single dose of 20mg oral rosuvastatin on Day 1 and Day 19 only.

Also known as: Crestor
Arm A - rucaparib and oral rosuvastatin
Oral ContraceptivesDRUG

Single dose of combined oral contraceptive (30 μg ethinylestradiol and 150 μg levonorgestrel) on Day 1 and Day 19 only.

Arm B - rucaparib and oral contraceptives

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBoth male and female patients are eligible for Arm A. Female patients only are eligible for Arm B.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • \- Male or female patients ≥ 18 years of age
  • \- Female patients ≥ 18 years of age

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

PRA Magyarország Fázis I-es Klinikai Farmakológiai Vizsgálóhely FMC Dialízis Központ, II. em.

Budapest, 1076, Hungary

Location

Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej

Biała Podlaska, 21-500, Poland

Location

BioVirtus Centrum Medyczne

Józefów, 05-410, Poland

Location

Ujastek Sp. z o.o. Centrum medyczne

Krakow, 31-752, Poland

Location

Med Polonia Sp. z o.o.

Poznan, 60-693, Poland

Location

Zdrowie Kobiety Centrum Leczniczo-Rehabilitacyjne i Medycyny Pracy ATTIS Sp. z o.o., Zakład Onkologii Kobiecej

Warsaw, 01-401, Poland

Location

Summit Clinical Research s.r.o.

Bratislava, 831 01, Slovakia

Location

Related Publications (1)

  • Liao M, Jeziorski KG, Tomaszewska-Kiecana M, Lang I, Jasiowka M, Skarbova V, Centkowski P, Ramlau R, Gornas M, Lee J, Edwards S, Habeck J, Nash E, Grechko N, Xiao JJ. A phase 1, open-label, drug-drug interaction study of rucaparib with rosuvastatin and oral contraceptives in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2021 Nov;88(5):887-897. doi: 10.1007/s00280-021-04338-7. Epub 2021 Aug 9.

    PMID: 34370076DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

rucaparibRosuvastatin CalciumContraceptives, Oral

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsContraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2019

First Posted

May 17, 2019

Study Start

April 25, 2019

Primary Completion

December 6, 2019

Study Completion

June 9, 2021

Last Updated

June 8, 2023

Record last verified: 2023-06

Locations

PL(5)SL(1)HU(1)