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Trial record 10 of 48 for:    rucaparib

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

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ClinicalTrials.gov Identifier: NCT03954366
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Clovis Oncology, Inc.

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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Rucaparib Drug: Rosuvastatin Drug: Oral Contraceptives Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : May 8, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Arm A - rucaparib and oral rosuvastatin Drug: Rucaparib
Rucaparib 600 mg BID commencing on Day 5 until Day 23.
Other Name: Rubraca

Drug: Rosuvastatin
Single dose of 20mg oral rosuvastatin on Day 1 and Day 19 only.
Other Name: Crestor

Arm B - rucaparib and oral contraceptives Drug: Rucaparib
Rucaparib 600 mg BID commencing on Day 5 until Day 23.
Other Name: Rubraca

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




Primary Outcome Measures :
  1. PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment. [ Time Frame: Day 1 to Day 23 ]
    Maximum plasma concentration (Cmax)

  2. 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)

  3. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. The following secondary PK parameter will be calculated for rucaparib. [ Time Frame: Day 1 to Day 23 ]
    Trough plasma concentration (Cmin)

  6. Incidence of Adverse Events [Safety and Tolerability] [ Time Frame: From Day 1 to last patient visit in Part II (approximately 2 years) ]
  7. Incidence of clinical laboratory abnormalities [Safety and Tolerability] [ Time Frame: From Day 1 to last patient visit in Part II (approximately 2 years) ]
  8. Incidence of dose modifications [Safety and Tolerability] [ Time Frame: From Day 1 to last patient visit in Part II (approximately 2 years) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Both male and female patients are eligible for Arm A. Female patients only are eligible for Arm B.
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03954366


Contacts
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Contact: Alex McNees 1-415-409-5440 amcnees@clovisoncology.com

Locations
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Hungary
PRA Magyarország Fázis I-es Klinikai Farmakológiai Vizsgálóhely FMC Dialízis Központ, II. em. Recruiting
Budapest, Hungary, 1076
Contact: Istvan Lang         
Poland
Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej Not yet recruiting
Biała Podlaska, Poland, 21-500
Contact: Piotr Centkowski         
BioVirtus Centrum Medyczne Not yet recruiting
Józefów, Poland, 05-410
Contact: Monika Tomaszewska-Kiecana         
Ujastek Sp. z o.o. Centrum medyczne Not yet recruiting
Kraków, Poland, 31-752
Contact: Marek Jasiówka         
Med Polonia Sp. z o.o. Not yet recruiting
Poznań, Poland, 60-693
Contact: Rodryg Ramlau         
Zdrowie Kobiety Centrum Leczniczo-Rehabilitacyjne i Medycyny Pracy ATTIS Sp. z o.o., Zakład Onkologii Kobiecej Not yet recruiting
Warszawa, Poland, 01-401
Contact: Maria Górnaś         
Slovakia
Summit Clinical Research s.r.o. Recruiting
Bratislava, Slovakia, 831 01
Contact: Viera Skarbova         
Sponsors and Collaborators
Clovis Oncology, Inc.

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Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT03954366     History of Changes
Other Study ID Numbers: CO-338-095
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clovis Oncology, Inc.:
rucaparib
CO-338
Clovis
Clovis Oncology
PARP Inhibitor
Drug-drug Interaction

Additional relevant MeSH terms:
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Rucaparib
Rosuvastatin Calcium
Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Ethinyl Estradiol
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Poly(ADP-ribose) Polymerase Inhibitors
Antineoplastic Agents