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Metastatic Carcinoma of the CervixPhase 1/2NIVIXNCT03644342

Study of Niraparib With Radiotherapy for Treatment of Metastatic Invasive Carcinoma of the Cervix

A Phase 1/2 study testing Nirapaib in people with Metastatic Carcinoma of the Cervix, run by Michelle S Ludwig at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The most effective strategy for managing distantly metastatic invasive carcinomas of the cervix is not defined. Based on the success of niraparib in breast and ovarian cancer trials and the concern for toxicities and comorbidities limiting the compliance of concurrent cisplatin for cervical cancer, this study is a… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Carcinoma of the Cervix
What is being tested?
Nirapaib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
3 sitesUnited States
Study dates
15 Jul 2019to 27 Sep 2023
Phase
Phase 1/2
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must have histologically confirmed diagnosis of invasive squamous cell or adenocarcinoma of the cervix, FIGO Stage IIIC2 or IV (see Appendix 5 of the currently approved protocol).
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
  • Participant must be ≥ 18 years of age.
  • Participant must have adequate organ function within 28 days of registration, defined as follows:
  • Absolute neutrophil count ≥ 1,500/µL
  • Platelets ≥ 100,000/µL
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  • Hemoglobin ≥ 9 g/dL
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation
  • Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) 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
  • Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy.
  • Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
  • Female participant of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration. Pregnancy test should be repeated within 7 days before CT simulation if more than 14 days has passed since the previous pregnancy test. (If serum test is falsely positive, pregnancy can be excluded by appropriate pelvic imaging.) Patient must agree to abstain from activities that could result in pregnancy from screening through completion of 7 days of pelvic radiotherapy. Females of non-childbearing potential is defined as follows (by other than medical reasons):
  • ≥45 years of age and has not had menses for >1 year
  • Post-hysterectomy, post-bilateral oophorectomy, post external beam radiation of 6 Gy to the pelvis, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by a physical exam or imaging.
  • Participant must agree to not breastfeed during the study and for 180 days after the last dose of study treatment.
  • Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent
  • Participant must have completed 3-6 cycles of platinum based chemotherapy (acceptable regimens in Appendix 7) with clinical evidence of CR (complete response) or PR (partial response) by RECIST criteria no less than 4 weeks and no greater than 12 weeks prior to initiation of protocol therapy. If bevacizumab used, 6 weeks must elapse between administration of bevacizumab and start of radiation therapy.
  • Participant must be eligible for chemoradiation treatment in the opinion of the treating investigator.
  • Participants who are HIV+ must have CD4 counts >200/dL and demonstrate documented HAART compliance
  • Chemotherapy-related hematological toxicities must have resolved to Grade 1 or less.
  • Participant must have had a CT (chest/abdomen/pelvis) or PET-CT, within 56 days of registration

Who cannot join

  • Participant must not be simultaneously enrolled in any interventional clinical trial.
  • Participant must not have known documented intra-uterine pregnancy.
  • Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
  • Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior to initiating protocol therapy. Participant that has received prior treatment with a PARP inhibitor is excluded from this study.
  • Participant last treatment with platinum based chemotherapy was ≥12 weeks from initiation of protocol therapy.
  • Participant must not receive any additional chemotherapy while on study.
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  • Participant has had radiation therapy encompassing >20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.
  • Participant must not have a known hypersensitivity to niraparib components or excipients.
  • Participant must not have received colony stimulating factors (e.g. granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior to initiating protocol therapy.
  • Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  • Participant must not have a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, NYHA Class III/IV heart failure, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, or any psychiatric disorder that prohibits obtaining informed consent. Participant must not have had a CVA within 6 months of registration.
  • Participant must not have had diagnosis, detection, or treatment of another type of cancer ≤ 2 years prior to initiating protocol therapy (except basal or squamous cell carcinoma of the skin that has been definitively treated).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Baylor St. Luke's Medical Center McNair

    Houston, Texas, 77030

  • Harris Health System - Smith Clinic

    Houston, Texas, 77054

Other trials in United States

About this study

Official title: Phase I/II Study of Niraparib With Radiotherapy for Treatment of Metastatic Invasive Carcinoma of the Cervix

The most effective strategy for managing distantly metastatic invasive carcinomas of the cervix is not defined. Based on the success of niraparib in breast and ovarian cancer trials and the concern for toxicities and comorbidities limiting the compliance of concurrent cisplatin for cervical cancer, this study is a phase I/II study of women diagnosed with distantly metastatic (Stage IV) disease to determine the maximum tolerated dose and to evaluate the safety, tolerability and preliminary efficacy of niraparib, an orally available small molecule PARP inhibitor when administered concurrently with definitive regional radiotherapy for treatment of cervical cancer. Women enrolled in this study will receive 3-6 cycles of induction-style carboplatin and paclitaxel followed by definitive doses of pelvic radiotherapy along with the oral niraparib given at the same time.

Being tested
Nirapaib
Keywords
cervical cancer, Niraparib, radiotherapy, carcinoma of the cervix
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

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

  • NirapaibDrug

    Also called Zejula

    (see treatment regimen and method of treatment assignment)

Study groups in NCT03644342
Study groupRoleWhat they receive
Niraparib Arm - 100 mgExperimentalFor the purposes of this study, two dose levels of Niraparib (100 mg will be evaluated concomitant with the concurrent administration of pelvic radiotherapy.
Receives: Drug: Nirapaib
Niraparib Arm - 200 mgExperimentalFor the purposes of this study, two dose levels of Niraparib (200 mg) will be evaluated concomitant with the concurrent administration of pelvic radiotherapy.
Receives: Drug: Nirapaib

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 Niraparib

    Maximum tolerated dose (MTD) of niraparib when administered concurrently with whole pelvic radiotherapy.

    The initial treatment dose is 100 mg, and for every 3 patients the dose is escalated and de-escalated, and additional patients are treated by the study design. Participants continue to be enrolled and assigned to treatment doses according to these rules until 17 efficacy evaluable participants are enrolled to any single dose level.

    Measured: 7 weeks during concurrent radiation therapy and niraparib administration

  2. Local Progression-free Survival

    Local progression-free survival for patients who have received 1 or more doses of niraparib with pelvic radiation as part of their treatment for metastatic cervical cancer.

    Measured: Up to 12 months from the time of treatment initiation to progression

Secondary outcomes (3)

  1. Acute Toxicity Profile of Niraparib

    acute toxicity profile of niraparib administered concurrently with whole pelvic radiotherapy according to the CTCAE version 4 as well as the grade of each toxicity. only serious adverse events will be reported here.

    Measured: 12 months after end of treatment, up to 1 year

  2. Quality of Life Measured Using FACT-Cx Questionnaire

    Functional Assessment of Cancer Therapy-Cervix (FACT Cx). It measures health related quality of life for people with cervical cancer in 4 domains: physical well being, social/family well being, emotional well being, and functional well being. All questions are a 0-4 scale. The total score is then calculated as the sum of the un-weighted subscale scores (0-27). For all FACIT scales and symptom indices, the higher the score the better the QOL

    Measured: 12 months after end of treatment

  3. Tumor Response

    Number of tumor responses outside the radiation field using RECIST 1.1 for women receiving niraparib concurrently with whole pelvic radiotherapy. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee (Version 1.1). Changes in only the largest unidimensional measurement (diameter) of index tumor lesions are used to assess response by RECIST criteria

    Measured: at 28 days after completing radiation therapy (XRT completion) and at every 3 months up to 12 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 Aug 2018
  2. Study start15 Jul 2019
  3. Primary completion18 Apr 2022
  4. Study completion27 Sep 2023

Why it stopped: A recent change in treatment landscape may make study futile

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03644342
Sponsor's protocol ID
H-40404
Acronym
NIVIX
Status last verified
Aug 2024
First submitted
4 Jun 2018
Last updated
3 Sep 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nirapaib in people with Metastatic Carcinoma of the Cervix, run by Michelle S Ludwig at 3 sites in United States.

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 22 inclusion and 12 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: stopped early, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 combined 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.

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?

Yes. Results are posted in the registry (first posted 18 Jun 2024). 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 Niraparib (time frame: 7 weeks during concurrent radiation therapy and niraparib administration). The study lists 2 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 NCT03644342.

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 3 Sep 2024.

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