Rucaparib Maintenance Therapy in Advanced Cervical Cancer

NCT03795272 | Withdrawn Phase 2 DMC

• 1 other identifier: ENGOT-Cx7-NSGO/MaRuC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cervical Cancer

Keywords

Cervical cancer; rucaparib; maintenance therapy; placebo-controlled

Outcome Measures

Primary Outcomes (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.

  42 months

Secondary Outcomes (3)

• Progression Free Survival in Sub-Population in months

  42 months

• Patient Reported Outcomes

  42 months

• Overall Survival in months

  60 months

Study Arms (2)

Rucaparib

EXPERIMENTAL

Patients will be treated with active oral drug, Rucaparib twice daily for 24 months

Drug: Rucaparib

Placebo

PLACEBO COMPARATOR

Patients will be treated with oral placebo twice daily for 24 months

Drug: Placebo

Interventions

Rucaparib DRUG

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

Also known as: active maintenance

Rucaparib

Placebo DRUG

placebo

Also known as: matched placebo maintenance

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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 -

Sponsors & Collaborators

• Nordic Society of Gynaecological Oncology - Clinical Trials Unit: lead
• Institute of Cancer Research, United Kingdom: collaborator
• Central and Eastern European Oncology Group: collaborator
• North Eastern German Society of Gynaecological Oncology: collaborator
• Belgian Gynaecological Oncology Group: collaborator
• Princess Margaret Hospital, Canada: collaborator
• PGOG (Polish Gynaecologic Oncology Group): collaborator
• GSO Global Clinical Research BV: collaborator
• GCP-enhederne: collaborator

Study Sites (2)

Rigshospitalet

Copenhagen, Region Sjælland, 2100, Denmark

Location

Rigshospitalet

København Ø, Region Sjælland, 2100, Denmark

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

rucaparib

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blinded placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2018
• First Posted: January 7, 2019
• Study Start: October 1, 2019
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

DK (2)