Status:
WITHDRAWN
Rucaparib Maintenance Therapy in Advanced Cervical Cancer
Lead Sponsor:
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Collaborating Sponsors:
Institute of Cancer Research, United Kingdom
Central and Eastern European Oncology Group
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-100 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy of PARP inhibitor, rucaparib as maintenance therapy for locally advanced cervical cancer
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 revea...
Eligibility Criteria
Inclusion
- 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
- 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. -
Exclusion
- 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.
- 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 -
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03795272
Start Date
October 1 2019
End Date
October 10 2019
Last Update
November 1 2019
Active Locations (2)
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1
Rigshospitalet
Copenhagen, Region Sjælland, Denmark, 2100
2
Rigshospitalet
København Ø, Region Sjælland, Denmark, 2100