Epithelial Ovarian Cancer, Fallopian Tube Cancer, Metastatic Castration-Resistant Prostate Cancer, Other Solid Tumor, Ovarian Cancer, Peritoneal Cancer
Conditions
Keywords
rucaparib, mCRPC, ovarian cancer, PARP inhibitor, PARPi, CRPC, solid tumor, Clovis Oncology, Antineoplastic agents, Genital Neoplasms, male, Prostatic Neoplasms, Ovarian Neoplasms
Brief summary
This protocol is designed to provide participants currently benefiting from rucaparib treatment in a Clovis-sponsored clinical study with continued access to treatment for as long as they continue to benefit. Participants in long-term follow-up (LTFU) in a parent study may also enroll in this study for continued data collection, as applicable based on parent study objectives.
Detailed description
Participants enrolled in this study are required to have completed an End-of-Treatment (EOT) Visit with associated assessments as specified in the Clovis-sponsored parent study (NCT01891344; NCT01968213; NCT02855944). Participants who are no longer receiving treatment and are in LTFU in the parent study (NCT02855944) may enroll into the LTFU portion of this study, as applicable based on parent study objectives, without repeating the EOT visit. The starting dose of rucaparib administered at initiation of this study will be the same as the last dose received in the parent study, or as deemed appropriate by the investigator and based on available dose strength tablets. The first treatment in the rollover study will begin at the next scheduled treatment visit following the EOT Visit in the parent study. Participants enrolled to receive continued rucaparib may be treated until disease progression, as assessed by the investigator, unacceptable toxicity, withdrawal of consent, death, loss to follow-up, or study closure by the sponsor. If a participant demonstrates disease progression per investigator assessment while receiving treatment with rucaparib but continues to derive clinical benefit, then continuation of treatment beyond progression is permitted based on investigator decision and participant consent. If a participant continues treatment post-progression, all study assessments should be continued per institutional standard of care. The participant should be discontinued from treatment once it is clear that no further clinical benefit can be achieved.
Interventions
DRUGRucaparib
Rucaparib will be administered daily.
Sponsors
pharmaand GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Currently enrolled in a Clovis-sponsored study of rucaparib that is being closed * Either: (a) Is currently tolerating a rucaparib treatment regimen in the parent study with evidence of clinical benefit, as assessed by the investigator, or (b) Has discontinued treatment and is being followed for collection of LTFU data in the parent study * Demonstrated compliance with the parent study requirements, as assessed by the investigator, and participant is able and willing to comply with the necessary study visits and assessments as part of the rollover study * Provided written informed consent prior to enrolling in this rollover study
Exclusion criteria
(applicable only to participants considered for continuation of rucaparib treatment): * Participant has been permanently discontinued from study treatment in the parent study for any reason * Pregnant or breastfeeding female patients * Presence of any other condition that may, in the opinion of the investigator, make the participant inappropriate for continuation of rucaparib treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing SAEs and AESIs | From first dose of rucaparib through 28 days after receiving last dose of rucaparib (approximately 20 months) | An SAE was any untoward medical occurrence that occurred at any dose, or after informed consent was given and prior to dosing if the SAE was related to a study procedure, that: resulted in death; was life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly or birth defect; or was an important medical event that may not have resulted in death, was not life-threatening, or did not require hospitalization but may be considered an SAE, based on appropriate medical judgment. An AESI was defined as any AE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. A summary of all SAEs regardless of causality is located in the 'Reported Adverse Events' Section. |
Countries
Canada, Israel, Italy, Poland, Russia, United Kingdom
Participant flow
Pre-assignment details
Only serious adverse event (SAE) and adverse event of special interest (AESI) safety data were collected, other (non-serious) adverse events (AEs) were not collected. Safety data were collected only for the Rucaparib arm (participants who received rucaparib during this study); safety data were not collected for the Long-term Follow-up arm (participants who did not receive rucaparib during this study).
Participants by arm
| Arm | Count |
|---|---|
| Rucaparib Participants received rucaparib at a dose and schedule last taken in the parent study, or per investigator decision. | 20 |
| Long-term Follow-up Participants discontinued rucaparib treatment and were in long-term follow-up in the parent study. | 14 |
| Total | 34 |
Baseline characteristics
| Characteristic | Long-term Follow-up | Total | Rucaparib |
|---|---|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 7.04 | 59.7 years STANDARD_DEVIATION 8.11 | 59.2 years STANDARD_DEVIATION 8.92 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 7 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 26 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 32 Participants | 20 Participants |
| Sex: Female, Male Female | 14 Participants | 33 Participants | 19 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 2 / 20 |
Outcome results
Primary
Number of Participants Experiencing SAEs and AESIs
An SAE was any untoward medical occurrence that occurred at any dose, or after informed consent was given and prior to dosing if the SAE was related to a study procedure, that: resulted in death; was life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly or birth defect; or was an important medical event that may not have resulted in death, was not life-threatening, or did not require hospitalization but may be considered an SAE, based on appropriate medical judgment. An AESI was defined as any AE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. A summary of all SAEs regardless of causality is located in the 'Reported Adverse Events' Section.
Time frame: From first dose of rucaparib through 28 days after receiving last dose of rucaparib (approximately 20 months)
Population: Safety Population: all participants who received rucaparib during the study (Rucaparib arm), safety data were not collected for the Long-term Follow-up arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rucaparib | Number of Participants Experiencing SAEs and AESIs | SAEs | 2 Participants |
| Rucaparib | Number of Participants Experiencing SAEs and AESIs | AESIs | 0 Participants |