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Cervical CancerPhase 2MaRuCNCT03795272

Rucaparib Maintenance Therapy in Advanced Cervical Cancer

A Phase 2 study testing Rucaparib in people with Cervical Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 2 sites in Denmark.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To evaluate the efficacy of PARP inhibitor, rucaparib as maintenance therapy for locally advanced cervical cancer Read more about this study

Who is it for?
Ages 18 to 100 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Rucaparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
2 sitesDenmark
Study dates
1 Oct 2019to 10 Oct 2019
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 100 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed squamous cell, adenocarcinoma or adenosquamous carcinoma of the cervix.
  • Patient must have completed definitive chemoradiation and is evaluated to be in complete remission 10-12 week's post definitive treatment.
  • Initial FIGO stage IIB with positive nodes (histological verification or verified by MRI/PET-CT), FIGO stages IIIA, IIIB, IVA; or any stage with para-aortic metastases (including IB and IIA with positive aortic nodes).
  • Toxicities resulting from definitive treatment must resolve to grade ≤1 prior to randomization.
  • Patient must consent that archival tumour tissue can be collected at the time of screening and used for translational studies.
  • Patient must consent to collection of whole blood and blood plasma during the study period. These samples will be stored and later used for translational studies.
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  • Patient agrees to undergo all analysis; radiological examinations according to protocol.
  • The patient agrees to complete PROs (QoL questionnaire) during study treatment.
  • Patients must give informed consent.
  • Patients must be at least 18 years of age.
  • ECOG performance status 0-1
  • Serum albumin >30g/l.
  • Adequate organ function
  • Absolute neutrophil count (ANC) ≥1,500/mcL
  • Platelets >100,000/mcL
  • Haemoglobin ≥ 9g/dl (no blood transfusions for 4 weeks prior entering the trial.)
  • Serum creatinine ≤1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥50mL/min using Cockcroft-Gault formula.
  • Total bilirubin ≤1.5x ULN.
  • Alanine aminotransferase (ALT) ≤2.5x ULN
  • Life expectancy of at least 12 weeks.
  • Women of childbearing potential must use highly effective methods of birth control for the duration of study participation and for 6 months afterwards.
  • All patients: Patients should not donate blood or blood components while participating in this study and through 90 days after receipt of the final dose of IMP. -

Who cannot join

  • Histological types other than in inclusion criteria, like sarcomas, small cell carcinoma with neuroendocrine differentiation, non-epithelial cancers.
  • Concurrent cancer therapies or cancer therapy (chemotherapy, radiotherapy, surgery, immunotherapy, biologic or hormonal therapy) within last 4 weeks.
  • Concurrent treatment with an investigational agent or participation in another clinical trial.
  • Previous malignant disease: patients are not eligible for the study if actively being treated of invasive cancer. Patients with previous malignant disease who are relapse-free and treatment-free for more than three years may enter this study. Patients with previous history of in-situ carcinoma of cervix, or non-invasive basal cell and squamous cell skin carcinoma can enter this trial.
  • Active infections or other serious underlying significant medical illness, abnormal laboratory finding or psychiatric illness/social situation that would, in the investigator's judgment, make the patient inappropriate for this study. Known active or chronic hepatitis C and/or B infection. Has known history of tuberculosis.
  • Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug.
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  • Any evidence of distant metastases.
  • Significant cardiovascular diseases, including uncontrolled hypertension, clinically relevant cardiac arrhythmia, unstable angina or myocardial infarction within 6 months prior to randomization, congestive heart failure >NYHA II (New York Heart Association), severe peripheral vascular disease, clinically significant pericardial effusion.
  • Pregnancy or breastfeeding. Patients with preserved reproductive capacity, unwilling to use a medically acceptable method of contraception for the duration of the trial and for 6 months afterwards.
  • Known hypersensitivity to the trial drugs, or to their excipients.
  • Persons who have been committed to an institution by official or judicial order
  • Patients with dependency on the sponsor, investigator or study site -

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Rigshospitalet

    Copenhagen, Region Sjælland, 2100

  • Rigshospitalet

    København Ø, Region Sjælland, 2100

Other trials in Denmark

About this study

Official title: A Randomized Double-blind Placebo-controlled Phase II Trial of Rucaparib Maintenance Therapy for Patients With Locally Advanced Cervical Cancer.

To evaluate the efficacy of PARP inhibitor, rucaparib as maintenance therapy for locally advanced cervical cancer

Read the detailed description

The use of concomitant cisplatin-based chemo-radiation for cervical cancer has improved survival of locally advanced cervical cancer patients and has become the standard of care. A meta-analysis revealed that the addition of concurrent chemotherapy to radiation increased the 5-year overall survival rate by 6% (HR 0.81: 60 vs 66%), and 5-year disease-free survival rate by 8%, though there is still considerable need for improvement as most patients who relapse are incurable. The unmet need is particularly higher in patients that are at high risk of recurrence. The main negative prognostic factors are higher FIGO stage as well as the presence of positive lymph nodes. Current studies are evaluating role of adjuvant chemotherapy following chemo-radiation in locally advanced disease and will possibly improve survival by reducing risk of distant metastases, however at the cost of excessive toxicity.

PARP inhibitors have shown considerable clinical benefit especially in platinum-sensitive relapsed ovarian cancer. Several PARP inhibitors have been evaluated in other gynaecological malignancies and three PARP inhibitors (olaparib, rucaparib \& niraparib) are approved by European Medicines Agency and Food \& Drug Administration for treatment or as maintenance therapy in ovarian cancer. Human papillomavirus causes oxidative stress that may result in DNA single-strand breaks. In cervical cancer PARP-1 expression/activity may be up-regulated in response to the ongoing oxidative stress (HPV and inflammation), and this may promote progression. This may create a vicious circle of inflammation, PARP activation, NAD+ consumption, adenosine triphosphate consumption, necrosis, and inflammation. PARPi may limit the role of PARP-1 in promoting inflammation and oxidative stress. There is theoretical plausibility that PARPi may have a role in the treatment of cervical carcinoma.

This phase II randomized placebo-controlled double-blind study will evaluate the efficacy and safety of rucaparib as adjuvant treatment for patients with locally advanced cervical cancer who are responding to chemo-radiation. This investigator-initiated study will be performed within the GCIG/ENGOT collaboration

Conditions
Cervical Cancer
Being tested
Rucaparib, Placebo
Keywords
Cervical cancer, rucaparib, maintenance therapy, placebo-controlled
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.

  • RucaparibDrug

    Also called active maintenance

    2:1 randomization to receive rucaparib/placebo twice daily for 24 month

  • PlaceboDrug

    Also called matched placebo maintenance

    placebo

Study groups in NCT03795272
Study groupRoleWhat they receive
RucaparibExperimentalPatients will be treated with active oral drug, Rucaparib twice daily for 24 months
Receives: Drug: Rucaparib
PlaceboPlacebo comparatorPatients will be treated with oral placebo twice daily for 24 months
Receives: Drug: Placebo

What is being measured

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

  1. Progression-Free Survival in months

    the time from randomization until the date of the first objective radiological disease progression according to investigator assessment of RECIST v1.1 or death by any cause, whichever occurs first.

    Measured: 42 months

Secondary outcomes (3)

  1. Progression Free Survival in Sub-Population in months

    the time from randomization until the date of the first objective radiological disease progression according to investigator assessment of RECIST v1.1 or death by any cause, whichever occurs first for the predefined study subgroups.

    Measured: 42 months

  2. Patient Reported Outcomes

    Quality of Life Questionnaire

    Measured: 42 months

  3. Overall Survival in months

    the time from randomization until the date of death by any cause

    Measured: 60 months

Timeline

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

  1. First posted7 Jan 2019
  2. Study start1 Oct 2019
  3. Primary completion10 Oct 2019
  4. Study completion10 Oct 2019

Why it stopped: Lack of financial support

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
Randomised
Intervention model
Parallel groups
Model description
This is a multicentre, phase 2, double-blind, placebo-controlled trial of maintenance rucaparib to obtain evidence of clinical benefit of rucaparib in locally advanced cervical cancer.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03795272
Sponsor's protocol ID
ENGOT-Cx7-NSGO/MaRuC
Acronym
MaRuC
Status last verified
Oct 2019
First submitted
3 Nov 2018
Last updated
1 Nov 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rucaparib in people with Cervical Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 2 sites in Denmark.

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: withdrawn, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.

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?

Progression-Free Survival in months (time frame: 42 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 NCT03795272.

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 1 Nov 2019.

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