CancerPhase 1NCT02476552
Absorption, Metabolism, Excretion, and the Determination of Absolute Bioavailability of Niraparib in Subjects With Cancer
A Phase 1 study testing Niraparib Oral Capsules (Labeled), Niraparib IV (Labeled) and Niraparib Oral Capsules (Unlabeled) in people with Cancer, run by Tesaro, Inc. at 1 site in Netherlands.
Trial summary
This is an open-label study with 2 parts, plus an extension study following completion of Parts 1 or 2, that is being conducted in approximately 12 subjects (6 subjects in Part 1; 6 subjects in Part 2) with cancer to examine the absorption, metabolism, excretion, and absolute bioavailability of niraparib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Niraparib Oral Capsules (Labeled), Niraparib IV (Labeled) and Niraparib Oral Capsules (Unlabeled)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2015to Jan 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
- Subject, male or female, is at least 18 years of age.
- Subject has histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumors that have failed to respond to standard therapy, have progressed despite standard therapy, refuse standard therapy, or for which no standard therapy exists, and that may benefit from treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor. The diagnosis must be confirmed with a previous computed tomography (CT) scan.
- The subject has adequate organ function:
- Subject must have an ECOG performance status of 0 to 2.
- Female subjects of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin [hCG]) within 72 hours prior to receiving the first dose of study drug.
Who cannot join
- Subject has undergone palliative radiotherapy within 1 week of study drug administration, encompassing >20% of the bone marrow.
- Subject has persistent >Grade 2 toxicity from prior cancer therapy.
- Subject has known hypersensitivity to the components of niraparib.
- Subject has had major surgery within 3 weeks of study drug administration or has not recovered from all effects of any major surgery.
- Subject is considered a medical risk due to a serious, uncontrolled medical disorder; nonmalignant systemic disease; or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days of the Screening Visit) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
- Subject has participated in a radioactive clinical study and has received an investigational radiolabeled drug within 6 months prior to study drug administration (for subjects participating in Part 2)
Trial locations and contacts
1 site in 1 country.
About this study
This is an open-label study with 2 parts, plus an extension study following completion of Parts 1 or 2, that is being conducted in approximately 12 subjects (6 subjects in Part 1; 6 subjects in Part 2) with cancer to examine the absorption, metabolism, excretion, and absolute bioavailability of niraparib.
Read the detailed description
Part 1: After an overnight fast of at least 10 hours, subjects will receive a single, oral dose of niraparib (unlabeled active pharmaceutical ingredient) on Day 1. Two hours after the oral dose, subjects will receive a 15-minute IV infusion of niraparib (labeled pharmaceutical ingredient).
Part 2: After an overnight fast of at least 10 hours, subjects will receive a single, oral dose of niraparib, labeled active pharmaceutical ingredient.
- Conditions
- Cancer
- Being tested
- Niraparib Oral Capsules (Labeled), Niraparib IV (Labeled), Niraparib Oral Capsules (Unlabeled)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niraparib Oral Capsules (Labeled)Drug
Single 300 mg dose of niraparib
Niraparib IV (Labeled)Drug
Intravenous (IV) infusion of 100 μg niraparib (containing approximately 1 μCi of [14C]-niraparib)
Niraparib Oral Capsules (Unlabeled)Drug
Single 300 mg dose of niraparib (unlabeled active pharmaceutical ingredient)
| Study group | Role | What they receive |
|---|---|---|
| Niraparib Oral and IV | Experimental | Single Oral dose of Niraparib capsules (unlabeled active pharmaceutical ingredient) orally and a 15-minute IV infusion of Niraparib (labeled active pharmaceutical ingredient) Receives: Drug: Niraparib IV (Labeled); Drug: Niraparib Oral Capsules (Unlabeled) |
| Niraparib Oral | Experimental | Single Oral dose of Niraparib capsules (labeled active pharmaceutical ingredient) Receives: Drug: Niraparib Oral Capsules (Labeled) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral bioavailability (F) will be derived using F=AUCoral / AUCiv as a %
Absolute bioavailability of niraparib will be calculated as the ratio of dose normalized oral to IV niraparib exposure
Measured: 0 - 22 days
Secondary outcomes (2)
AUC0-last
AUC (Area Under the Curve) from time 0 to the last quantifiable concentration
Measured: 0 - 22 days
Cmax
Observed Maximum plasma Concentration
Measured: 0 - 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tesaro, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shefali Agarwal, MD, Study director, Tesaro, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476552
- Sponsor's protocol ID
- PR-30-5015-C
- Status last verified
- Jan 2020
- First submitted
- 29 May 2015
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption, Metabolism, Excretion, and the Determination of Absolute Bioavailability of Niraparib in Subjects With Cancer
- ClinicalTrials.gov ID
- NCT02476552
- Acronym / sponsor ID
- PR-30-5015-C
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tesaro, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label study with 2 parts, plus an extension study following completion of Parts 1 or 2, that is being conducted in approximately 12 subjects (6 subjects in Part 1; 6 subjects in Part 2) with cancer to examine the absorption, metabolism, excretion, and absolute bioavailability of niraparib.
Detailed description
Part 1: After an overnight fast of at least 10 hours, subjects will receive a single, oral dose of niraparib (unlabeled active pharmaceutical ingredient) on Day 1. Two hours after the oral dose, subjects will receive a 15-minute IV infusion of niraparib (labeled pharmaceutical ingredient).
Part 2: After an overnight fast of at least 10 hours, subjects will receive a single, oral dose of niraparib, labeled active pharmaceutical ingredient.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Niraparib Oral and IV | Experimental | Drug: Niraparib IV (Labeled), Drug: Niraparib Oral Capsules (Unlabeled)Single Oral dose of Niraparib capsules (unlabeled active pharmaceutical ingredient) orally and a 15-minute IV infusion of Niraparib (labeled active pharmaceutical ingredient) |
| Niraparib Oral | Experimental | Drug: Niraparib Oral Capsules (Labeled)Single Oral dose of Niraparib capsules (labeled active pharmaceutical ingredient) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject, male or female, is at least 18 years of age.
- Subject has histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumors that have failed to respond to standard therapy, have progressed despite standard therapy, refuse standard therapy, or for which no standard therapy exists, and that may benefit from treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor. The diagnosis must be confirmed with a previous computed tomography (CT) scan.
- The subject has adequate organ function:
- Subject must have an ECOG performance status of 0 to 2.
- Female subjects of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin [hCG]) within 72 hours prior to receiving the first dose of study drug.
Key exclusion criteria (6 listed)
- Subject has undergone palliative radiotherapy within 1 week of study drug administration, encompassing >20% of the bone marrow.
- Subject has persistent >Grade 2 toxicity from prior cancer therapy.
- Subject has known hypersensitivity to the components of niraparib.
- Subject has had major surgery within 3 weeks of study drug administration or has not recovered from all effects of any major surgery.
- Subject is considered a medical risk due to a serious, uncontrolled medical disorder; nonmalignant systemic disease; or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days of the Screening Visit) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niraparib Oral Capsules (Labeled)Single 300 mg dose of niraparib | Drug | Niraparib Oral |
| Niraparib IV (Labeled)Intravenous (IV) infusion of 100 μg niraparib (containing approximately 1 μCi of [14C]-niraparib) | Drug | Niraparib Oral and IV |
| Niraparib Oral Capsules (Unlabeled)Single 300 mg dose of niraparib (unlabeled active pharmaceutical ingredient) | Drug | Niraparib Oral and IV |
Primary outcome
Oral bioavailability (F) will be derived using F=AUCoral / AUCiv as a %
Time frame: 0 - 22 days
Absolute bioavailability of niraparib will be calculated as the ratio of dose normalized oral to IV niraparib exposure
2 secondary outcomes
AUC0-last
Time frame: 0 - 22 days
Cmax
Time frame: 0 - 22 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shefali Agarwal, MD study director
Tesaro, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Niraparib Oral Capsules (Labeled), Niraparib IV (Labeled) and Niraparib Oral Capsules (Unlabeled) in people with Cancer, run by Tesaro, Inc. at 1 site in Netherlands.
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 5 inclusion and 6 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 13 Jan 2020. 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 Netherlands. 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?
Oral bioavailability (F) will be derived using F=AUCoral / AUCiv as a % (time frame: 0 - 22 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2020.