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Ovarian CarcinomaPhase 2NCT05311579

Niraparib Plus Anlotinib for Recurrent Ovarian Cancer

A Phase 2 study testing Niraparib plus anlotinib in people with Ovarian Carcinoma and Survival Outcomes, run by Lei Li at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase II trial to explore efficacy and safety of niraparib in combination with anlotinib based on CA 125 level in newly diagnosed ovarian cancer. After completion of 1st-line platinum-based chemotherapy with a normal CA-125 concentration, in patients with CA-125 increased > 35U/ml, and with no evidence of… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Niraparib plus anlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
27 Mar 2022to 27 Mar 2024
Phase
Phase 2
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

  • Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent
  • Patients must be female ≥18 years of age
  • Patients must have histologically diagnosed non-mucinous ovarian cancer that is Stage III or IV according to FIGO criteria, and niraparib is used as 1st maintenance therapy after achieving CR/PR to front-line platinum-containing chemotherapy
  • After completion of front-line platinum-based chemotherapy with a normal CA-125 concentration: CA-125 increased > 35U/ml on 2 occasions (Repeat CA 125 any time but normally not less than 1 week after the first elevated CA 125 level), and with no evidence of imaging recurrence
  • After completion of front-line platinum-based chemotherapy, CA125 decreased by 90% and was not in the normal range: the level of CA125 at the end of chemotherapy as the nadir, CA-125 increased to 2 x nadir on 2 occasions (Repeat CA 125 any time but normally not less than 1 week after the first elevated CA 125 level), and with no evidence of imaging recurrence
  • Allow to combinate bevacizumab during front-line chemotherapy
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  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patients must have adequate organ function, defined as follows:
  • Absolute neutrophil count ≥ 1,500/μL
  • Platelets ≥ 100,000/μL
  • Hemoglobin ≥ 10 g/dL
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault equation
  • Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN
  • Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
  • Pregnancy test results were negative and patients willing to use appropriate contraceptive methods while in the trial and within 3 months after the last dose of this study treatment; or keep abstinence during the trial; or women with no potential fertility.
  • Ability to comply with protocol.
  • All of the adverse events caused by chemotherapy recovered to Common Terminology Criteria Adverse Events (CTCAE) grade 1 or baseline, except for stable sensory neuropathy or hair loss ≤ CTCAE grade 2.

Who cannot join

  • Allergy to active or inactive ingredients of niraparib or drugs with similar chemical structures.
  • Allergy to active or inactive ingredients of anlotinib or drugs with similar chemical structures.
  • Active and uncontrollable brain metastasis or leptomeningeal metastasis. Patients with spinal cord compression can still be considered if they have received targeted treatment and have evidence of clinical stability of the disease for at least > 28 days (controlled brain metastasis must have received radiotherapy or chemotherapy at least 1 month prior to study entry; patients may not have new symptoms related to brain lesions or symptoms indicating disease progression and either take stable dose of hormone or do not need to take hormone).
  • Major surgery performed within 3 weeks before enrollment, or any surgical effects that have not recovered from the surgery, or chemotherapy.
  • Palliative radiotherapy encompassing >20% of the bone marrow within 1 week of the first dose of study treatment
  • Any other malignant tumor exclude ovarian cancer has been diagnosed within 2 years before enrollment (except for completely treated basal or squamous cell skin cancer).
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  • Current or previous myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
  • Other severe or uncontrolled diseases, including but not limited to:
  • Uncontrollable nausea and vomiting, inability to swallow study drug, and any gastrointestinal disease that may interfere with the absorption and metabolism of the drug
  • Active viral infections, such as human immunodeficiency virus, hepatitis B virus, hepatitis C virus and so on
  • Uncontrolled epileptic seizures, unstable spinal cord compression, superior vena cava syndrome or other psychiatric disorders that may affect patients' informed consent
  • Immunodeficiency (except for splenectomy), or other diseases that investigators believe may expose patients to high-risk toxicity.
  • Have the risk or tendency of bleeding and history of thrombosis
  • CTCAE grade 2 bleeding event occurred within 3 months prior to screening or CTCAE ≥ grade 3 bleeding event occurred within 3 months prior to screening
  • Have history of gastrointestinal bleeding or confirmed bleeding tendency within 6 months prior to screening. e.g. esophageal varices with bleeding risk, local active ulcer focus or fecal occult blood above ++
  • Have active bleeding or coagulation dysfunction, have bleeding risk or undergoing thrombolytic or anticoagulant therapy
  • Need anticoagulant therapy with warfarin or heparin
  • Need long-term anti-platelet therapy (e.g. aspirin, clopidogrel)
  • Have occurred thrombus or embolism event in past 6 months, e.g. cerebral vascular accident（including transient cerebral ischemic attack), pulmonary embolism
  • A history of severe cardiovascular disease:
  • New York Heart Association (NYHA) grade 3/4 congestive heart failure (CHF)
  • Unstable angina or newly diagnosed angina/myocardial infarction within 12 months prior to screening
  • Cardiac arrhythmia despite need medication (patients taking β-receptor blockers or digoxin can be enrolled)
  • CTCAE ≥ grade 2 valvular heart disease
  • Poorly controlled hypertension (systolic pressure>150 mmHg or diastolic pressure>100 mmHg)
  • The following laboratory indexed are abnormal:
  • Hyponatremia (serum sodium < 130 mmol/L); baseline serum potassium < 3.5 mmol/L (potassium supplements can be used to restore serum potassium above this before enrollment)
  • Thyroid dysfunction and cannot maintain normal despite medical treatment
  • Previous/current diseases and treatment or abnormal laboratory indexed those interfere with study result or participation of the whole study; or the investigator confirmed not suitable for this trial; have platelet or red blood cell transfusion within 4 weeks prior to the first dose of study treatment
  • Patients must not be pregnant, breastfeeding, or expecting to conceive children, while receiving study treatment
  • Corrected QT interval（QTc>450 milliseconds); if patients have QTc prolongation because of cardiac pacemaker confirmed by investigator and no other cardiac disorder, whether enrollment need further discussion with investigator

Trial locations and contacts

1 site in 1 country.

Lei Li, M.D. contact

86-139-1198-8831

lileigh@163.com

China1 site, 1 recruiting

  • Lei Li

    Beijing, Beijing Municipality, 100730

    Lei Li, M.D., 8613911988831, lileigh@163.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Niraparib in Combination With Anlotinib Based on CA 125 Level in Newly Diagnosed Ovarian Cancer: A Open-label, Single Arm, Prospective Phase II Trial

This is a phase II trial to explore efficacy and safety of niraparib in combination with anlotinib based on CA 125 level in newly diagnosed ovarian cancer. After completion of 1st-line platinum-based chemotherapy with a normal CA-125 concentration, in patients with CA-125 increased > 35U/ml, and with no evidence of imaging recurrence, niraparib and anlotinib are used as 1st maintenance therapy for newly diagnosed advanced ovarian cancer after achieving complete or partial remission to platinum-containing chemotherapy. The primary objective of this study is to explore the efficacy of niraparib combined with anlotinib based on CA 125 level in newly diagnosed ovarian cancer with no evidence of imaging recurrence. A total o f36 patients will be enrolled in this study.

Being tested
Niraparib plus anlotinib
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • Niraparib plus anlotinibCombination product

    Niraparib QD D1-21 plus Anlotinib 10mg QD D1-14 until disease progression or intolerable toxicity

    21days/cycle

Study groups in NCT05311579
Study groupRoleWhat they receive
Ovarian cancer patients with increased CA125ExperimentalPatients with CA125 >35 U/ml or increased to 2 x nadir, and with no evidence of imaging recurrence after completion of 1st-line platinum-based chemotherapy
Receives: Combination Product: Niraparib plus anlotinib

What is being measured

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

  1. Progression free survival (PFS)

    Progression free survival (PFS) by RECIST v 1.1

    Measured: 24 months

Secondary outcomes (3)

  1. Time to first subsequent therapy (TFST)

    Time to first subsequent therapy (TFST)

    Measured: 24 months

  2. Overall survival (OS)

    Overall survival (OS)

    Measured: 48 months

  3. Adverse events

    Adverse event (AE), Treatment emergent adverse event (TEAE), Serious adverse event (SAE)

    Measured: 24 months

Timeline

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

  1. First posted5 Apr 2022
  2. Study start27 Mar 2022
  3. Primary completion27 Mar 2023 (estimated)
  4. Study completion27 Mar 2024 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05311579
Sponsor's protocol ID
NIRAN1
Status last verified
Apr 2022
First submitted
27 Mar 2022
Last updated
13 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Niraparib plus anlotinib in people with Ovarian Carcinoma and Survival Outcomes, run by Lei Li at 1 site 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 17 inclusion and 31 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: status not confirmed, as of the sponsor's last update on 13 Apr 2022. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Lei Li, M.D. (86-139-1198-8831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) (time frame: 24 months). 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 NCT05311579.

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 Apr 2022.

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