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Advanced Solid TumorsPhase 1NCT03497429

A Study of Niraparib as Single Agent in Participants With Advanced Solid Tumors

A Phase 1 study testing Niraparib in people with Advanced Solid Tumors, run by Takeda at 1 site in Japan.

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 evaluate the safety, tolerability and pharmacokinetics of Niraparib in Japanese participants with advanced solid tumors. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
Niraparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteJapan
Study dates
5 Apr 2018to 10 Feb 2020
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Japanese male or female participants aged 20 years or older on the day of signing informed consent.
  • Participants must have a cytologically- or histologically-confirmed metastatic or locally advanced solid tumor and have failed or progressed after standard therapy, or for which standard therapy does not exist in the opinion of the investigator.
  • Participants must have Performance Status of less than or equal to (<=) 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale.
  • Participants must have adequate organ function as indicated by the following laboratory values:
  • Hematology
  • Absolute neutrophil count: greater than or equal to (>=) 1500 per microliter (μL)
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  • Platelet count: >=100,000/μL
  • Hemoglobin: >=9 gram per deciliter (g/dL)
  • Kidney
  • Serum creatinine: <=1.5*institutional upper limit of normal (ULN), OR creatinine clearance of >=50 milliliter per minute (mL/min) (as calculated using the Cockcroft Gault equation or measured using 24-hour urine creatinine clearance) for participants with creatinine levels >=1.5*institutional ULN.
  • Liver
  • Total bilirubin in serum: <=1.5*ULN (except in participants with Gilbert's syndrome). Participants with Gilbert's syndrome may be enrolled if the participant's direct bilirubin is <=1.5*ULN of the direct bilirubin.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): <=2.5*ULN OR <=5*ULN if participants have liver metastases.
  • Coagulation (does not pertain to participants receiving anticoagulants)
  • Prothrombin time (PT): <=1.2*ULN
  • Activated partial thromboplastin time (aPTT): <=1.2*ULN
  • Female participants who:
  • Are postmenopausal for at least 1 year before the screening visit, OR
  • Are surgically sterile, OR
  • If they are of childbearing potential, agree to practice one highly effective method of contraception and one additional effective (barrier) method at the same time, from the time of signing the informed consent through 180 days after the last dose of study drug, OR
  • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], condoms only, withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
  • Male participants, even if surgically sterilized (ie, vasectomy), who:
  • Agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug. If the female partner of a male participant is of child bearing potential, it should also be advised to use a highly effective method of contraception, OR
  • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner], condoms only, withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
  • Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.

Who cannot join

  • Participant who have received chemotherapy, radiotherapy, hormonal or biological therapy within 14 days (within 28 days for anticancer monoclonal antibody, within 42 days for nitrosoureas or mitomycin C) prior to Cycle 1 Day 1. If the participant has residual toxicity from prior chemotherapy treatment, such toxicity must be <=Grade 1 (NOTE: participants with Grade 2 alopecia may qualify for this study). If bevacizumab had been used in the past, all bevacizumab-related toxicities must have resolved. Participants with prostate cancer may have been treated with luteinizing hormone-releasing hormone (LH-RH) analogs.
  • Participants who received a known or putative poly (ADP-ribose) polymerase (PARP) inhibitor or other drugs that may inhibit the PARP, either as part of a clinical trial or as standard of care.
  • Participants who initiated bisphosphonate therapy or are adjusting bisphosphonate dose/regimen within 30 days prior to Cycle 1 Day 1. Participants on a stable bisphosphonate regimen are eligible and may continue the treatment.
  • Treatment with any investigational products within 28 days or 5 half-lives (whichever was longer) before Cycle 1 Day 1.
  • Participants who have symptomatic ascites or a symptomatic pleural effusion. A participant who is treated and clinically stable for these conditions is eligible.
  • Participants with a known primary central nervous system (CNS) tumor.
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  • Participants with known CNS metastases and/or carcinomatous meningitis are excluded. However, participants with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for 30 days prior to Cycle 1 Day 1 defined as: (1) no evidence of new or enlarging CNS metastases, (2) off steroids, or (3) on a stable dose and administration of steroids.
  • Participants who have a hypersensitivity to the components of the study drugs or their analogs.
  • Participants who are considered to be at high medical risk due to a serious, uncontrolled disease, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days prior to Cycle 1 Day 1) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, uncontrolled hypertension, or any psychiatric disorder that prohibits obtaining informed consent.
  • Participants who have a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the participant's participation throughout the study period, or study participation is not in the best interest of the participant.
  • Known gastrointestinal (GI) disease or GI surgery that could interfere with the GI absorption of study drug, such as difficulty swallowing capsules and total gastrectomy.
  • Participants who have a psychiatric disorder that may interfere with the conduct of the trial.
  • Participant is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or had a recent history (within the past year) of drug or alcohol abuse.
  • Participants who are pregnant or breast-feeding, or expecting to conceive or be a father of children within the planned duration of the study.
  • NOTE: If a breast-feeding woman discontinue breast-feeding, she may be enrolled in the study.
  • Known human immunodeficiency virus positive.
  • Known hepatitis B surface antigen (HBsAg) positive, or known or suspected active hepatitis C virus (HCV) infection.
  • NOTE: Participants who are positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) can be enrolled but must have an undetectable hepatitis B virus (HBV) viral load. Participants who have positive hepatitis C virus antibody (HCVAb) must have an undetectable HCV viral load.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • National Cancer Center Hospital

    Chuo-ku, Tokyo

Other trials in Japan

About this study

Official title: A Phase 1, Open-label Study of Niraparib as Single Agent in Patients With Advanced Solid Tumors

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of Niraparib in Japanese participants with advanced solid tumors.

Read the detailed description

The drug being tested in this study is called Niraparib. Niraparib is being tested to treat Japanese participants with advanced solid tumors. This study will look at the safety, tolerability and pharmacokinetics of Niraparib administered once daily orally.

The study will enroll approximately 12 participants as a maximum. Participants will be assigned to Cohort 1 (21-day treatment cycle). After that, participants will be assigned to Cohort 2 when safety and tolerability of the 200 mg dose will be demonstrated.

This single-center trial will be conducted in Japan. The overall time to participate in this study is approximately 16 months. Participants will make multiple visits to the clinic with final visit approximately 28 days after last dose of study drug for a follow-up assessment.

Being tested
Niraparib
Keywords
Drug Therapy

What participants receive

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

Study groups in NCT03497429
Study groupRoleWhat they receive
Cohort 1: Niraparib 200 mgExperimentalNiraparib 200 milligrams (mg), capsule, once orally on Days 1 - 21 of each 21-day treatment cycle.
Receives: Drug: Niraparib
Cohort 2: Niraparib 300 mgExperimentalNiraparib 300 mg, capsule, once orally on Days 1 - 21 of each 21-day treatment cycle.
Receives: Drug: Niraparib

What is being measured

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

  1. Number of Participants With Dose Limiting Toxicities (DLTs)

    DLT was evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), v4.03 and defined as any of the following events occurring during Cycle 1 that were considered by investigator to be related with niraparib: Any Grade 5 or 4 hematologic toxicity, except Grade 4 neutropenia less than (<) 7 days; Grade 3 or 4 neutropenia with fever greater than (>) 38.5 degree Celsius and/or infection requiring antibiotic/anti-fungal treatment; Any Grade 3, 4,or 5 non-hematologic toxicity except: Grade 3 nausea, vomiting, diarrhea/dehydration occurring in setting of inadequate compliance with supportive care and lasting <48 hours, Inadequately treated hypersensitivity reactions, Grade 3 acidosis/alkalosis that responded to intervention by improving to less than or equal to (<=) Grade 2 within 48 hours, Isolated asymptomatic Grade 3 amylase elevation, hypercholesterolemia and hypertriglyceridemia; Any TEAE leading to an interruption of niraparib for >14 days.

    Measured: Baseline up to Day 21 in Cycle 1 (Cycle length=21 days)

  2. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Measured: From the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)

  3. Number of Participants With Grade 3 or Higher TEAEs

    TEAEs were graded as per the NCI-CTCAE version 4.03. As per the NCI-CTCAE, Grade 1 (mild, asymptomatic or mild symptoms); Grade 2 (moderate, minimal, local or noninvasive intervention indicated); Grade 3 (severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (life-threatening consequences, urgent intervention indicated); Grade 5 (death related to adverse event [AE]).

    Measured: From the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)

  4. Number of Participants With Serious TEAEs

    Measured: From the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)

  5. Number of Participants Who Discontinued Study Drug Due to TEAEs

    Measured: From the first dose of the study drug up to 28 days after the last dose of the study drug (up to Cycle 22 Day 49) (Cycle length =21 days)

Secondary outcomes (3)

  1. Cmax: Maximum Observed Plasma Concentration for Niraparib

    Measured: Cycle 1 Days 1 and 21: pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length =21 days)

  2. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Niraparib

    Measured: Cycle 1 Days 1 and 21: pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length =21 days)

  3. AUC24：Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours for Niraparib

    Measured: Cycle 1 Days 1 and 21: pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length =21 days)

Timeline

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

  1. First posted13 Apr 2018
  2. Study start5 Apr 2018
  3. Primary completion10 Feb 2020
  4. Study completion10 Feb 2020

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
Sequential
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03497429
Sponsor's protocol ID
Niraparib-1001
Other IDs
U1111-1209-0340, JapicCTI-183911
Status last verified
Oct 2021
First submitted
5 Apr 2018
Last updated
9 Nov 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites.)

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Niraparib in people with Advanced Solid Tumors, run by Takeda at 1 site in Japan.

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 25 inclusion and 18 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 Nov 2021. 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 Japan. 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?

Yes. Results are posted in the registry (first posted 9 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Baseline up to Day 21 in Cycle 1 (Cycle length=21 days)). The study lists 5 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 NCT03497429.

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 Nov 2021.

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