Multiple solid tumor types MedDRA version: 20.0 Level: PT Classification code 10038977 Term: Retroperitoneal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10061328 Term: Ovarian epithelial cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10016180 Term: Fallopian tube cancer Sys
Conditions
Sponsors
Clovis Oncology, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients must be currently enrolled in a Clovis-sponsored study of rucaparib that is being closed and have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF); are currently tolerating and benefitting from rucaparib treatment in the parent study, as assessed by the investigator, or have discontinued treatment and be in follow-up for collection of LTFU data; have demonstrated compliance with the parent study requirements and are able and willing to comply with the necessary study visits and assessments as part of the rollover study; and for patients continuing treatment with rucaparib, have not received any intervening anticancer therapy since discontinuing the parent study. 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 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Patients will be excluded from receiving further rucaparib treatment if they have been permanently discontinued from rucaparib in the parent study for any reason. Women of childbearing potential (WOCBP) must not be considering getting pregnant during continued treatment and for 6 months following the last dose of rucaparib. Male patients with female partners of reproductive potential or who are pregnant who refuse to use effective contraception during treatment and for 3 months following the last dose of rucaparib are excluded. Male patients who are considering making semen donations during treatment or within 3 months following the last dose of rucaparib will also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Provide ongoing rucaparib treatment to patients who participated in a Clovis-sponsored study and who are assessed as continuing to benefit from rucaparib at the time of study closure;;Secondary Objective: Collect serious adverse events (SAEs) and adverse events of special interest (AESIs) Collect long-term follow-up (LTFU) data, as applicable based on parent study objectives. ;Primary end point(s): No end points ;Timepoint(s) of evaluation of this end point: No timepoints | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No secondary endpoints ;Timepoint(s) of evaluation of this end point: No secondary timepoints | — |
Countries
Brazil, Canada, Czechia, Czech Republic, Hungary, Israel, Italy, Poland, Russian Federation, Spain, Ukraine, United Kingdom
Contacts
Public ContactChief Medical Officer
Clovis Oncology UK Ltd
Outcome results
None listed