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Ovarian CancerPhase 1NCT03551171

The Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian Cancer

A Phase 1 study testing ZL-2306 (niraparib) in people with Ovarian Cancer, run by Zai Lab (Shanghai) Co., Ltd. at 6 sites in China.

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

Niraparib is a potent and highly selective PARP-1/-2 inhibitor. The primary objective of this trial is to evaluate the pharmacokinetic (PK) properties of ZL-2306 (niraparib) and its metabolite M1 in patients from Mainland China with ovarian cancer, following a single and multiple oral administration of the study drug… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
ZL-2306 (niraparib)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
6 sitesChina
Study dates
19 Dec 2017to 10 Jul 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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent .
  • Female, age ≥ 18 years.
  • Histologically confirmed diagnosis of FIGO stage III or IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
  • Has received no further than second-line platinum-based chemotherapy, and has clinical complete response (CR) or partial response (PR) at least following 4 courses of the last platinum-based chemotherapy.
  • ECOG 0-1.
  • Has good organ function, including:
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  • Patient of childbearing potential, has a negative pregnancy test when enrolled and promises to use an adequate method of contraception or abstain from activities that could result in pregnancy from enrolment to the end of study and during the 3 months after the last dose of the study treatment, or be of non-childbearing potential, can be enrolled in the study.
  • Is able to adhere to the protocol.
  • Has recovered from previous chemotherapy induced toxic side effects to ≤ grade 1 CTCAE or basal level, apart from ≤ grade 2 CTCAE peripheral neuropathy or hair loss symptoms at steady state.

Who cannot join

  • Has a known hypersensitivity to the active or inactive ingredients of ZL-2306 (niraparib) or compound which has similar chemical structure to ZL-2306 (niraparib).
  • Has symptomatic uncontrolled brain or leptomeningeal metastasis.
  • Major surgery or chemotherapy within 3 weeks of starting the study or patient has not recovered from any effects of the surgery.
  • Receive palliative radiotherapy encompassing > 20% of the bone marrow within 1 week of entering the study.
  • Be diagnosed any invasive cancer other than ovarian cancer (apart from cured basal cell carcinoma and squamous cell carcinoma) within 2 years prior to study enrolment.
  • Has a history or current diagnosis of myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML).
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  • Has other serious or uncontrolled disease
  • Has any disease, treatment and laboratory abnormality that may interfere the study results and affect the fully attendance of study. Or the patient is considered to be not suitable for the study by the investigator. Cannot receive platelet or red blood cell transfusion within 4 weeks of study drug administration.
  • Pregnant, breastfeeding or expecting to conceive children during the study treatment period.
  • Corrected QT (QTc) interval > 470 msec.
  • Use proton pump inhibitors, antacids or histamine 2 (H2) blockers within 48hrs prior to the first drug administration for PK measurement.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100000

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • The West China Second UniversityHospital of Sichuan University

    Chengdu, Sichuan, 610000

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

  • Haerbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Fudan University Shanghai Cnacer Center

    Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

Official title: An Open-Label,Single-Arm,Phase I Clinical Trial to Evaluate the Pharmacokinetics,Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian Cancer,Fallopian Tube Cancer and Primary Peritoneal Cancer (Collectively Termed as Ovarian Cancer)

Niraparib is a potent and highly selective PARP-1/-2 inhibitor. The primary objective of this trial is to evaluate the pharmacokinetic (PK) properties of ZL-2306 (niraparib) and its metabolite M1 in patients from Mainland China with ovarian cancer, following a single and multiple oral administration of the study drug at the indicated dose (300mg, 200mg or 100mg), once a day.

Conditions
Ovarian Cancer
Being tested
ZL-2306 (niraparib)
Keywords
PARP inhibitor, BRCA mutation
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • ZL-2306 (niraparib)Drug

    About 30 subjects will be enrolled to the study, and randomised into 300mg, 200mg and 100mg dose groups (about 10 subjects per group).

    All subjects will be randomised into indicated dose group (300mg, 200mg or 100mg) at the first day of the first cycle. A single administration of ZL-2306 (niraparib) will be given to the subjects at indicated dose.

Study groups in NCT03551171
Study groupRoleWhat they receive
ZL-2306 (niraparib)ExperimentalSubjects will be randomised into 100mg, 200mg, 300mg dose group at the first day of the first cycle.
Receives: Drug: ZL-2306 (niraparib)

What is being measured

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

  1. Maximum plasma drug concentration (Cmax)

    Measured: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)

  2. Time to reach Cmax (Tmax)

    Measured: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)

  3. Terminal rate constant (λz)

    Measured: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)

  4. Elimination half-life (t1/2)

    Measured: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)

  5. Area under the plasma concentration-time curve from time zero to 24hrs (AUC (0-24))

    Measured: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)

  6. Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUC(0-t)) and from zero to infinity (AUC0-∞)

    Measured: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)

  7. Apparent total body clearance of the drug from plasma (CL/F)

    Measured: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)

  8. Apparent volume of distribution (Vd/f)

    Measured: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)

  9. Mean residence time (MRT)

    Measured: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)

  10. Degree of fluctuation (DF)

    Measured: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)

  11. Maximum plasma drug concentration at steady-state (Css max)

    Measured: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)

  12. Time to reach Css max (Tss max)

    Measured: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)

  13. Minimum plasma drug concentration at steady-state (Css min)

    Measured: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)

  14. Area under the plasma concentration-time curve from time zero to the end of drug administration (AUCss)

    Measured: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)

  15. Steady-state apparent total body clearance of drug from plasma (Clss/F)

    Measured: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)

  16. Accumulation ratio following multiple drug administration (RAC)

    Measured: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)

  17. The plasma drug concentration before drug administration

    Measured: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)

Secondary outcomes (1)

  1. Number of participants with adverse events as assessed by CTCAE v4.0

    Measured: From the signing of ICF till the end of this study (30 days after the last administration of the study drug or the date to close the clinical trial database, whichever is earlier)

Timeline

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

  1. First posted11 Jun 2018
  2. Study start19 Dec 2017
  3. Primary completion3 May 2018
  4. Study completion10 Jul 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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03551171
Sponsor's protocol ID
ZL-2306-002
Status last verified
May 2018
First submitted
20 Apr 2018
Last updated
24 Jan 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang J, Zheng H, Gao Y, Lou G, Yin R, Ji D, Li W, Wang W, Xia B, Wang D, Hou J, Yan J, Hei Y, Zhang ZY, Milton A, Wu X. Phase I Pharmacokinetic Study of Niraparib in Chinese Patients with Epithelial Ovarian Cancer. Oncologist. 2020 Jan;25(1):19-e10. doi: 10.1634/theoncologist.2019-0565. Epub 2019 Aug 22.

    PubMed 31439812

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ZL-2306 (niraparib) in people with Ovarian Cancer, run by Zai Lab (Shanghai) Co., Ltd. at 6 sites in China.

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 9 inclusion and 11 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 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. 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?

Maximum plasma drug concentration (Cmax) (time frame: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)). The study lists 17 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 NCT03551171, 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 24 Jan 2019.

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