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Solid TumorPhase 1AMENCT02986100

Absorption, Metabolism, and Excretion Following a Single Oral Dose of [14C]-Rucaparib

A Phase 1 study testing C-14 labeled Rucaparib and Rucaparib in people with Solid Tumor, run by pharmaand GmbH at 1 site in Hungary.

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

The purpose of this study is to characterize the mass balance, absorption, metabolism, and elimination pathways of orally administered [14C] rucaparib followed by cycle by cycle treatment with rucaparib continuing until disease progression or other reason for discontinuation Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
C-14 labeled Rucaparib and Rucaparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteHungary
Study dates
Nov 2016to Sep 2018
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

  • Histologically or cytologically confirmed advanced solid tumor
  • Part II only: Have a known deleterious BRCA1/2 mutation (germline or somatic) as determined by a local or central laboratory
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate bone marrow, renal, and liver function

Who cannot join

  • Prior treatment with chemotherapy, radiation, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, or angiogenesis inhibitors within 14 days prior to Day 1
  • Participation in a trial involving administration of [14C]-labeled compound(s) within the last 6 months prior to Day 1
  • Arterial or venous thrombi (including cerebrovascular accident), myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within the last 3 months prior to Screening
  • Pre-existing duodenal stent, recent or existing bowel obstruction, and/or any gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib
  • Untreated or symptomatic central nervous system (CNS) metastases
  • Evidence or history of bleeding disorder
Show all 9Show fewer
  • Participation in another investigational drug trial within 14 days prior to Day 1 (or 5 times the half-life of the drug, whichever is longer) or exposure to more than three new investigational agents within 12 months prior to Day 1
  • Acute illness (eg, nausea, vomiting, fever, diarrhea) within 14 days prior to Day 1, unless mild in severity and approved by the Investigator and Sponsor's/designated medical representative
  • Active second malignancy

Trial locations and contacts

1 site in 1 country.

Hungary1 site

  • PRA Magyarország Kft.

    Budapest, Rottenbiller Utca 13, 1077

Other trials in Hungary

About this study

Official title: An Open-Label, Non-Randomized, Phase I Study to Assess the Absorption, Metabolism, and Excretion Following a Single Oral Dose of [14C]-Rucaparib in Patients With Advanced Solid Tumors

The purpose of this study is to characterize the mass balance, absorption, metabolism, and elimination pathways of orally administered [14C] rucaparib followed by cycle by cycle treatment with rucaparib continuing until disease progression or other reason for discontinuation

Read the detailed description

This is a Phase 1, open-label, non-randomized, mass balance study in patients with histologically or cytologically confirmed advanced solid tumors. Approximately 6 patients will be enrolled. The study will consist of 2 parts: a mass balance part (Part I) and a rucaparib treatment part (Part II).

Each patient will receive a single oral dose of 600 mg [14C] rucaparib (approximately 140 µCi) in the fasted state. Patients will be confined at the study site for the collection of blood samples and excreta for a maximum of 13 days, from Day -1. The patient can be discharged sooner than Day 13, if the discharge criteria are met. If the cumulative recovery of radioactivity exceeds 90% of the administered dose or if radioactivity in urine and feces is < 1% of the administered dose over a 24 hour period on two consecutive days, as determined by quick counts.

In Part II, the treatment with rucaparib in 28-day cycles will continue until progression of disease, unacceptable toxicity, or other reason for discontinuation.

Conditions
Solid Tumor
Being tested
C-14 labeled Rucaparib, Rucaparib
Keywords
rucaparib, CO-338, Clovis, Clovis Oncology, PARP inhibitor, Absorption, Metabolism, Excretion

What participants receive

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

  • C-14 labeled RucaparibDrug

    Each dosage unit consists of a hard gelatin capsule filled with cold rucaparib camsylate and [14C]-rucaparib camsylate salt. Each capsule contains approximately 150 mg rucaparib (free base weight) and approximately 35 µCi of [14C]-rucaparib. Each patient will ingest four capsules in the fasted state for a total dose of 600 mg rucaparib (free base weight) with approximately 140 µCi of [14C]-rucaparib

  • RucaparibDrug

    Also called CO-338, Rubraca

    200 \& 300 mg tablet

Study groups in NCT02986100
Study groupRoleWhat they receive
C-14 labeled rucaparibExperimentalEach patient will receive a single oral dose of 600 mg [14C] rucaparib (approximately 140 µCi) in the fasted state. Patients will be confined at the study site for the collection of blood samples and excreta for a maximum of 13 days, from Day -1. The patient can be discharged sooner than Day 13, if the discharge criteria are met. After completion of Part I, patients with a deleterious BRCA mutation will have the option to participate in Part II by receiving 600 mg BID rucaparib tablets orally in 28 day cycles until disease progression, unacceptable toxicity, death, or discontinuation for other reasons
Receives: Drug: C-14 labeled Rucaparib; Drug: Rucaparib

What is being measured

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

  1. Pharmacokinetics of 14C-labeled rucaparib (radioactivity in whole blood and plasma): tmax

    Time to peak concentration (tmax)

    Measured: Days 1-13

  2. Pharmacokinetics of 14C-labeled rucaparib(Radioactivity in whole blood and plasma): Cmax

    peak (maximum) concentration (Cmax)

    Measured: Days 1-13

  3. Pharmacokinetics of 14C-labeled rucaparib(Radioactivity in whole blood and plasma): t1/2

    Elimination half-life (t1/2)

    Measured: Days 1-13

  4. Pharmacokinetics of 14C-labeled rucaparib(Radioactivity in whole blood and plasma): AUC

    Area under curve (AUC)

    Measured: Days 1-13

  5. Pharmacokinetics of 14C-labeled rucaparib(Radioactivity in whole blood and plasma): CL/F

    Oral clearance (CL/F)

    Measured: Days 1-13

  6. Pharmacokinetics of 14C-labeled rucaparib(Radioactivity in whole blood and plasma): V/F

    Apparent volume of distribution (V/F)

    Measured: Days 1-13

  7. Excretion rate of 14C-labeled rucaparib(radioactivity in feces)

    Percent of dose excreted in feces

    Measured: Days 1-13

  8. Excretion rate of 14C-labeled rucaparib(radioactivity in urine)

    Percent of dose excreted in urine

    Measured: Days 1-13

  9. Pharmacokinetics of rucaparib (in urine): CLR

    Renal clearance (CLR)

    Measured: Days 1-13

  10. Excretion rate of 14C-labeled rucaparib(radioactivity in vomit, if applicable)

    Percent of dose in vomit, if applicable

    Measured: Days 1-13

  11. Metabolite identification of rucaparib in plasma, urine and feces

    Measured: Days 1-13

  12. Cumulative whole blood:plasma ratio calculated for Cmax

    peak concentration (Cmax)

    Measured: Days 1-13

  13. Cumulative whole blood:plasma ratio calculated for AUC0-tlast

    AUC from time zero to the last time point with concentration above the lower limit of quantitation (AUC0-last)

    Measured: Day 1-13

  14. Cumulative whole blood:plasma ratio calculated for AUCinf

    AUC from time zero to infinity (AUCinf)

    Measured: Day 1-13

Secondary outcomes (1)

  1. Tolerability and safety of rucaparib assessed by incidence of Adverse Events (AEs), clinical laboratory abnormalities, and dose modifications

    Incidence of Adverse Events (AEs), clinical laboratory abnormalities, and dose modifications

    Measured: From cycle 1 Day 1 until radiologically confirmed disease progression, death, or initiation of subsequent treatment whichever comes first up to 52 weeks

Timeline

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

  1. First posted8 Dec 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionDec 2017
  4. Study completionSep 2018

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02986100
Sponsor's protocol ID
CO-338-045
Other IDs
2015-004394-32, 2015
Acronym
AME
Status last verified
Jun 2023
First submitted
14 Nov 2016
Last updated
9 Jun 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing C-14 labeled Rucaparib and Rucaparib in people with Solid Tumor, run by pharmaand GmbH at 1 site in Hungary.

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 4 inclusion and 9 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 9 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 1 site in Hungary. 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?

Pharmacokinetics of 14C-labeled rucaparib (radioactivity in whole blood and plasma): tmax (time frame: Days 1-13). The study lists 14 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 NCT02986100.

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 9 Jun 2023.

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