Trial Outcomes & Findings for CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib (NCT NCT04676334)
NCT ID: NCT04676334
Last Updated: 2024-05-07
Results Overview
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.
COMPLETED
PHASE3
34 participants
From first dose of rucaparib through 28 days after receiving last dose of rucaparib (approximately 20 months)
2024-05-07
Participant Flow
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).
Participant milestones
| Measure |
Rucaparib
Participants received rucaparib at a dose and schedule last taken in the parent study, or per investigator decision.
|
Long-term Follow-up
Participants discontinued rucaparib treatment and were in long-term follow-up in the parent study.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
14
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
20
|
0
|
|
Overall Study
COMPLETED
|
20
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib
Baseline characteristics by cohort
| Measure |
Rucaparib
n=20 Participants
Participants received rucaparib at a dose and schedule last taken in the parent study, or per investigator decision.
|
Long-term Follow-up
n=14 Participants
Participants discontinued rucaparib treatment and were in long-term follow-up in the parent study.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 8.92 • n=99 Participants
|
60.5 years
STANDARD_DEVIATION 7.04 • n=107 Participants
|
59.7 years
STANDARD_DEVIATION 8.11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Rucaparib
n=20 Participants
Participants received rucaparib at a dose and schedule last taken in the parent study, or per investigator decision.
|
|---|---|
|
Number of Participants Experiencing SAEs and AESIs
SAEs
|
2 Participants
|
|
Number of Participants Experiencing SAEs and AESIs
AESIs
|
0 Participants
|
Adverse Events
Rucaparib
Serious adverse events
| Measure |
Rucaparib
n=20 participants at risk
Participants received rucaparib at a dose and schedule last taken in the parent study, or per investigator decision.
|
|---|---|
|
General disorders
Fatigue
|
5.0%
1/20 • From first dose of rucaparib through 28 days after receiving last dose of rucaparib (approximately 20 months)
Only SAE and AESI safety data were collected, other (non-serious) 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). Data reported for Safety Population: all participants who received rucaparib during the study.
|
|
Infections and infestations
Pneumonia
|
5.0%
1/20 • From first dose of rucaparib through 28 days after receiving last dose of rucaparib (approximately 20 months)
Only SAE and AESI safety data were collected, other (non-serious) 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). Data reported for Safety Population: all participants who received rucaparib during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.0%
1/20 • From first dose of rucaparib through 28 days after receiving last dose of rucaparib (approximately 20 months)
Only SAE and AESI safety data were collected, other (non-serious) 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). Data reported for Safety Population: all participants who received rucaparib during the study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor's agreements with investigators require proposed public disclosures of trial results to be submitted to Sponsor for review prior to publication. Sponsor may request deletion of confidential information or a delay in publication to address intellectual property concerns, but Sponsor may not suppress publication of the trial results indefinitely. Sponsor may request delay of a single-center publication until after the release of a multi-site publication or an agreed upon period of time.
- Publication restrictions are in place
Restriction type: OTHER