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Platinum-resistant Recurrent Clear Cell Ovarian CancerPhase 2CC-ANNIENCT05130515

Anlotinib Combined With Niraparib Dual Therapy in Platinum-resistant Recurrent Ovarian Clear Cell Carcinoma.

A Phase 2 study testing Niraparib and Anlotinib in people with Platinum-resistant Recurrent Clear Cell Ovarian Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site 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

According to the definition of National Comprehensive Cancer Network (NCCN), ovarian clear cell carcinoma (OCCC) is a less common subtype of epithelial ovarian cancer (EOC) . The preliminary trial ANNIE (NCT04376073) shows a promising efficacy and safety profile for the ANNIE combo (anlotinib+niraparib). Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Niraparib and Anlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
15 Dec 2021to 1 Jan 2023
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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patients understood the test process, signed the informed consent form and agreed to participate in the study.
  • 18 ~70 years old, female.
  • Histologically confirmed ovarian clear cell carcinoma.
  • The patients received platinum-based chemotherapy after primary debulking surgery, and experienced a recurrence or progression during the therapy; or experienced a recurrence or progression within 6 months after at least 4 cycles platinum-based therapy; or experienced a recurrence within 6 months after the end of the last platinum-based chemotherapy.
  • Definition of recurrence or progression: clearly documented radiographic progression or carbohydrate antigen (CA125) increased continuously (confirmed after 1 week) and accompanied by clinical symptoms or physical examination, indicating disease progression.
  • It is allowed to receive no more than 1 non-platinum regimen between 2 platinum-based regimens; Patients with disease recurrence or progression during platinum-based therapy or patients whose time from platinum-based treatment (at least 4 cycles) to disease recurrence and progression is less than 6 months are allowed to receive no more than 1 systematic treatment regimen.
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  • Expected survival more than 16 weeks.
  • ECOG (Eastern Cooperative Oncology Group) physical status score 0-1.
  • Good organ function.
  • Neutrophil counts ≥1500/µL
  • Platelet counts ≥100,000/µL
  • Hemoglobin ≥10g/dl
  • Serum creatinine≤1.5 times of the upper limit value, or creatinine clearance rate ≥ 60ml/min (according to Cockcroft Gault formula)
  • Total bilirubin≤1.5 times of the upper limit value or direct bilirubin ≤1.0 times of the upper limit value
  • Aspartate transaminase and alanine transaminase≤ 2.5 times of the upper limit value, and ≤5 times of the upper limit value when liver metastasis exists
  • Pregnancy test results were negative and patients willing to use appropriate contraceptive methods while in the trial and within 3 months after the last administration of CC-ANNIE combo; 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.
  • At least 1 measurable lesions (according to RECIST 1.1)
  • The interval between initial administration of CC-ANNIE combo and previous chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other antitumor therapy should be at least 4 weeks, or at least 6 weeks if the chemotherapy regimen includes mitomycin.

Who cannot join

  • Any poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitors treatment history.
  • 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 a 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 been recovered from the surgery, or chemotherapy.
  • >20% bone marrow palliative radiotherapy performed within 1 week before enrollment.
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  • 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).
  • Combined with central squamous cell carcinoma of lungs or at risk of massive hemoptysis (such as bronchiectasis and uncured tuberculosis).
  • Myelodysplastic syndromes (MDS) or acute myelocytic leukemia (AML).
  • Serious or uncontrollable diseases, including but not limited to:
  • uncontrollable nausea and vomiting, inability to swallow the study drug, any gastrointestinal disease that may interfere with drug absorption and metabolism.
  • active viral infections such as human immunodeficiency virus, hepatitis B, hepatitis C, etc.
  • uncontrolled major seizures, unstable spinal cord compression, superior vena cava syndrome or other mental disorders that affect the patient's informed consent.
  • immune deficiency (except splenectomy), or other diseases that researchers believe may expose patients to high-risk toxicity.
  • Prone to bleeding and history of thrombosis:
  • Any CTCAE grade 2 bleeding events occurred within 3 months, or ≥ CTCAE grade 3 bleeding events occurred within 6 months.
  • A history of gastrointestinal bleeding or a clear tendency of gastrointestinal bleeding within 6 months. For example, esophageal varices with bleeding risk, local active ulcer lesions, or occult blood in stool++
  • Active bleeding or abnormal coagulation function, have bleeding tendency, or are receiving thrombolytic or anticoagulant therapy
  • Need anticoagulant therapy with warfarin or heparin
  • Need long-term antiplatelet therapy (such as aspirin and clopidogrel)
  • Thrombotic or embolic events occurred in the past 6 months, such as cerebrovascular accidents (including transient ischemic attack) and pulmonary embolism.
  • History of severe cardiovascular disease:
  • New York Heart Association (NYHA) Grade 3 and 4 congestive heart failure.
  • Unstable angina or newly diagnosed angina or myocardial infarction within 12 months prior to study.
  • Arrhythmias requiring therapeutic intervention (patients taking beta-blockers or digoxin can be included).
  • CTCAE≥2 valvular heart disease.
  • Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg).
  • Abnormal laboratory tests:
  • Hyponatremia (sodium < 130 mmol/L); Baseline serum potassium < 3.5mmol /L (potassium supplement can be used before entering the study).
  • Abnormal thyroid function that cannot be maintained within normal limits with medication.
  • Any prior or current disease, treatment, or laboratory abnormality that may interfere with the study results or affect the patient's full participation in the study, or that the investigator deems the patient unsuitable for the study. Patients should not receive platelet or red blood cell transfusions within 4 weeks before the start of treatment with the study drug.
  • Pregnancy or lactation, or expected pregnancy during study treatment.
  • Q-T interval corrected (QTc)>450 ms. If the patient has prolonged QTc interval, but the investigator assessed the reason for the prolonged period as pacemaker (without other cardiac abnormalities), discussion with the investigator will be required to determine whether the patient is suitable for study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: An Open-Label, Single Arm, Phase II Trial of Niraparib in Combination With Anlotinib in Patients With Platinum-Resistant Recurrent or Platinum-Refractory Clear Cell Ovarian Cancer.

According to the definition of National Comprehensive Cancer Network (NCCN), ovarian clear cell carcinoma (OCCC) is a less common subtype of epithelial ovarian cancer (EOC) . The preliminary trial ANNIE (NCT04376073) shows a promising efficacy and safety profile for the ANNIE combo (anlotinib+niraparib). There is limited progress in targeted therapy for those less common ovarian cancers. In this study (CC-ANNIE), we aim to evaluate the antitumor activity and safety of niraparib combined with anlotinib in patients with platinum-resistant or platinum-refractory OCCC.

Read the detailed description

The CC-ANNIE trial is a single-arm, single-center, exploratory phase II trial. Eligible patients (≥18 \& ≤70 years) are histologically confirmed platinum-resistant recurrent OCCC and 20 subjects are planned to be enrolled. All subjects must have measurable lesions (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) and are going to be treated with niraparib 200mg once daily, anlotinib 10mg on day 1-14 of each 21-day cycle thereafter until disease progression or intolerable toxicity. The primary endpoint is the objective response rate.

Being tested
Niraparib, Anlotinib
Keywords
clear cell ovarian cancer, Platinum-resistant cancer, Niraparib, Anlotinib

What participants receive

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

  • NiraparibDrug

    Niraparib 200mg po QD, day1~21

  • AnlotinibDrug

    Anlotinib 10mg po QD, day1~14, 3 weeks/cycle

Study groups in NCT05130515
Study groupRoleWhat they receive
Treatment groupExperimentalNiraparib 200mg po QD day1~21, Anlotinib 10mg po QD day1~14
Receives: Drug: Niraparib; Drug: Anlotinib

What is being measured

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

  1. Objective response rate

    The primary objective of this study is to determine the preliminary efficacy of administration of niraparib in combination with anlotinib in the treatment of platinum-resistant recurrent or platinum-refractory clear cell ovarian cancer, as measured by the objective response rate (ORR), which is a combination of CR (complete response, the target lesion completely disappeared over 4 weeks) and PR (partial response, the target lesions were reduced by more than 30% for more than 4 weeks).

    Measured: at 6 months

Secondary outcomes (5)

  1. The frequency and severity of adverse events

    The frequency and severity of adverse events and toxicity based upon CTCAE version 5.0 during subjects receiving the study treatment.

    Measured: Baseline through 1.5 year

  2. Duration of response

    Duration of response is defined as the time from the first documentation of CR or PR to the first documentation of tumor progression, or to death due to any cause.

    Measured: at 12 months

  3. Time to response

    Time to response is defined as the time from date of enrollment to the date of first documented tumor response (CR or PR).

    Measured: at 6 months

  4. 24 weeks clinical benefit rate

    24 weeks clinical benefit rate is defined as the rate of CR plus PR and stabel disease (SD).

    Measured: at 24 weeks

  5. Objective response rate of homologous recombination deficient group

    The efficacy of administration of niraparib in combination with anlotinib in the homologous recombination deficient group.

    Measured: at 6 months

Timeline

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

  1. First posted23 Nov 2021
  2. Study start15 Dec 2021
  3. Primary completion1 Jan 2023
  4. Study completion1 Jan 2023

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
Model description
Drug: Niraparib Niraparib 200mg po QD day1\~21 Drug: Anlotinib Anlotinib 10mg po QD day1\~14.
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05130515
Sponsor's protocol ID
2021-KY-016
Acronym
CC-ANNIE
Status last verified
Nov 2022
First submitted
10 Nov 2021
Last updated
31 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the medresman site.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Niraparib and Anlotinib in people with Platinum-resistant Recurrent Clear Cell Ovarian Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 20 inclusion and 33 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 31 Jan 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 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?

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?

Objective response rate (time frame: at 6 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 NCT05130515.

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 31 Jan 2023.

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