Rucaparib maintenance treatment for cervical cancer

Phase 1

• Conditions: Cancer of uterine cervix; MedDRA version: 21.1 Level: LLT Classification code 10008229 Term: Cervical cancer System Organ Class: 100000004864; MedDRA version: 21.1 Level: LLT Classification code 10008233 Term: Cervical cancer stage I System Organ Class: 100000004864; MedDRA version: 21.1 Level: LLT Classification code 10008234 Term: Cervical cancer stage II System Organ Class: 100000004864; MedDRA version: 21.1 Level: LLT Classification code 10008235 Term: Cervical cancer stage III System Organ Class: 100000004864; MedDRA version: 21.1 Level: LLT Classification code 10008236 Term: Cervical cancer stage IV System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003756-20-SE
• Lead Sponsor: ordic Society of Gynaecological Oncology-Clinical Trial Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-29
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 162

Inclusion Criteria

1. Histologically confirmed squamous cell, adenocarcinoma or adenosquamous carcinoma of the cervix.
2. Patient must have completed definitive chemoradiation and is evaluated to be in complete remission 10-12 week’s post definitive treatment.
3. Initial FIGO stage IIIA, IIIB, IIIC, IVA (histological verification) according to the FIGO classification 2018.
4. Toxicities resulting from definitive treatment must resolve to grade =1 prior to randomization.
5. Patient agrees to undergo all analysis; radiological examinations according to protocol.
6. The patient agrees to complete PROs (QoL questionnaire) during study treatment.
7. Patients must give informed consent.
8. Patients must be at least 18 years of age.
9. ECOG performance status 0-1
10. Serum albumin >30g/l.
11. 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
12. Life expectancy of at least 12 weeks.
13. Women of childbearing potential must use highly effective methods of birth control for the duration of study participation and for 6 months afterwards.
14. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52

Exclusion Criteria

1.Histological types other than in inclusion criteria, like sarcomas, small cell carcinoma with neuroendocrine differentiation, non-epithelial cancers.
2. Concurrent cancer therapies or cancer therapy (chemotherapy, radiotherapy, surgery, immunotherapy, biologic or hormonal therapy) within last 4 weeks.
3. Concurrent treatment with an investigational agent or participation in another clinical trial.
4. 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.
5. 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.
6. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug.
7. Any evidence of distant metastases.
8. 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.
9. 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.
10. Known hypersensitivity to the trial drugs, or to their excipients.
11. Persons who cannot comply to the protocol or at the discretion of the investigator is unsuitable.
12. Patients with dependency on the sponsor, investigator or study site.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified