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NeoplasmsPhase 1NCT03954366

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

A Phase 1 study testing Rucaparib, Rosuvastatin and Oral Contraceptives in people with Neoplasms, run by pharmaand GmbH at 7 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
Rucaparib, Rosuvastatin and Oral Contraceptives
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
7 sitesin 3 countries
Study dates
25 Apr 2019to 9 Jun 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

7 sites in 3 countries.

7 sites in 3 countries

Poland5 sites

  • Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej

    Biała Podlaska, 21-500

  • BioVirtus Centrum Medyczne

    Józefów, 05-410

  • Ujastek Sp. z o.o. Centrum medyczne

    Krakow, 31-752

  • Med Polonia Sp. z o.o.

    Poznan, 60-693

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

    Warsaw, 01-401

Other trials in Poland

Hungary1 site

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

    Budapest, 1076

Other trials in Hungary

Slovakia1 site

  • Summit Clinical Research s.r.o.

    Bratislava, 831 01

Other trials in Slovakia

About this study

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

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.

Read the 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.

Conditions
Neoplasms
Being tested
Rucaparib, Rosuvastatin, Oral Contraceptives
Keywords
rucaparib, CO-338, Clovis, Clovis Oncology, PARP Inhibitor, Drug-drug Interaction
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RucaparibDrug

    Also called Rubraca

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

  • RosuvastatinDrug

    Also called Crestor

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

  • Oral ContraceptivesDrug

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

Study groups in NCT03954366
Study groupRoleWhat they receive
Arm A - rucaparib and oral rosuvastatinOtherNot described
Receives: Drug: Rucaparib; Drug: Rosuvastatin
Arm B - rucaparib and oral contraceptivesOtherNot described
Receives: Drug: Rucaparib; Drug: Oral Contraceptives

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Maximum plasma concentration (Cmax)

    Measured: Day 1 to Day 23

  2. 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)

    Measured: Day 1 to Day 23

  3. 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)

    Measured: Day 1 to Day 23

Secondary outcomes (8)

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

    Terminal half-life (t1/2)

    Measured: Day 1 to Day 23

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

    Time to occurrence of Cmax (tmax)

    Measured: Day 1 to Day 23

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

    Apparent total clearance of drug after oral administration (CL/F)

    Measured: Day 1 to Day 23

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

    Apparent volume of distribution during terminal phase (Vz/F)

    Measured: Day 1 to Day 23

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

    Trough plasma concentration (Cmin)

    Measured: Day 1 to Day 23

  6. Incidence of Adverse Events [Safety and Tolerability]

    Measured: From Day 1 to last patient visit in Part II (approximately 2 years)

  7. Incidence of clinical laboratory abnormalities [Safety and Tolerability]

    Measured: From Day 1 to last patient visit in Part II (approximately 2 years)

  8. Incidence of dose modifications [Safety and Tolerability]

    Measured: From Day 1 to last patient visit in Part II (approximately 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2019
  2. Study start25 Apr 2019
  3. Primary completion6 Dec 2019
  4. Study completion9 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03954366
Sponsor's protocol ID
CO-338-095
Status last verified
Jun 2023
First submitted
2 Apr 2019
Last updated
8 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34370076

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rucaparib, Rosuvastatin and Oral Contraceptives in people with Neoplasms, run by pharmaand GmbH at 7 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Poland, Hungary, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment. (time frame: Day 1 to Day 23). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03954366, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.

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