Trial Outcomes & Findings for Rucaparib in Nonmetastatic prOstAte With BRCAness (NCT NCT03533946)

Last Updated: 2024-03-13

Results Overview

The levels of PSA were monitored monthly for comparison to baseline levels until the time of PSA progression, or 2 years after study treatment discontinuation, or study termination, as defined by Prostate Cancer Working Group 3 (PCWG3) criteria. PCWG3 criteria for PSA progression is a rise over baseline of \>= 25% and an absolute rise of \>= 2 ng/mL. Reported as median number of months from baseline to PSA progression.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

From baseline to up to 2 years after study treatment discontinuation; actual max approximately 42 months

Results posted on

2024-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Rucaparib, All Participants Single Arm study, all participants will get rucaparib.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rucaparib in Nonmetastatic prOstAte With BRCAness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rucaparib, All Participants n=7 Participants Single Arm study, all participants will get rucaparib.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	69 years STANDARD_DEVIATION 5.98 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to up to 2 years after study treatment discontinuation; actual max approximately 42 months

Outcome measures

Outcome measures
Measure	Rucaparib, All Participants n=7 Participants Single Arm study, all participants will get rucaparib.
Prostate Specific Antigen Progression Free Survival	35.37 Months Interval 0.0 to 85.11

SECONDARY outcome

Timeframe: From first dose of study treatment until 30 days after last dose of study treatment; max 42 months

To assess the safety of rucaparib in participants with biochemically recurrent hormone-sensitive prostate cancer. Severity of adverse events was assessed using CTCAE v5.0 criteria, a 1-5 scale with higher numbers indicating greater severity, where Grade 1 indicates "mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated" and Grade 5 indicates "death related to AE." Each adverse event was also evaluated by the treating investigator to assess its attribution to rucaparib, with options being unrelated, unlikely related, possibly related, probably related, or definitely related to rucaparib. Possibly, probably, and definitely related were grouped together as "Related." Reported here are the number of participants with any related AE of the specified grade. Note that there were no Grade 4 or Grade 5 related AEs.

Outcome measures

Outcome measures
Measure	Rucaparib, All Participants n=7 Participants Single Arm study, all participants will get rucaparib.
Number of Participants With Adverse Events (AEs) Related to Rucaparib Grade 1	7 Participants
Number of Participants With Adverse Events (AEs) Related to Rucaparib Grade 2	4 Participants
Number of Participants With Adverse Events (AEs) Related to Rucaparib Grade 3	2 Participants

SECONDARY outcome

Timeframe: At 6 and 12 months after initiation of study therapy

Population: Three participants did not complete follow-up to 6 months, so only four could be evaluated.

To assess the percentage of participants with an undetectable PSA after initiation of study therapy at 6 and 12 months. Endpoint: the levels of PSA will be monitored monthly for comparison to baseline levels to determine when PSA becomes undetectable. Participants who were not followed for at least 6 months after initiation of study therapy were not able to be evaluated for this time point.

Outcome measures

Outcome measures
Measure	Rucaparib, All Participants n=4 Participants Single Arm study, all participants will get rucaparib.
Count of Participants With an Undetectable PSA at 6 and 12 Months At 6 months	1 Participants
Count of Participants With an Undetectable PSA at 6 and 12 Months At 12 months	1 Participants

SECONDARY outcome

Timeframe: From start of study treatment until up to 2 years after study treatment discontinuation; actual max approximately 42 months

To evaluate OS in nonmetastatic hormone-sensitive prostrate cancer participants treated with rucaparib. Calculated as the number of participants alive 2 years after study treatment discontinuation or study termination.

Outcome measures

Outcome measures
Measure	Rucaparib, All Participants n=7 Participants Single Arm study, all participants will get rucaparib.
Overall Survival (OS) at 2 Years	7 Participants

SECONDARY outcome

Timeframe: From baseline until up to 2 years after study treatment discontinuation; actual max approximately 42 months

To assess the number of participants with a 50% reduction in PSA levels (PSA50) compared to the baseline value at the time of study enrollment. The levels of PSA will be monitored monthly for comparison to baseline levels.

Outcome measures

Outcome measures
Measure	Rucaparib, All Participants n=7 Participants Single Arm study, all participants will get rucaparib.
Count of Participants With 50% or Greater Reduction in PSA Levels	2 Participants

Adverse Events

Rucaparib, All Participants

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rucaparib, All Participants n=7 participants at risk Single Arm study, all participants will get rucaparib.
Investigations Alanine aminotransferase increased	57.1% 4/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Investigations Alkaline phosphatase increased	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Blood and lymphatic system disorders Anemia	42.9% 3/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Metabolism and nutrition disorders Anorexia	28.6% 2/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Investigations Aspartate aminotransferase increased	28.6% 2/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Bloating	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Investigations Creatinine increased	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Dry mouth	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Nervous system disorders Dysgeusia	57.1% 4/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Respiratory, thoracic and mediastinal disorders Dyspnea	42.9% 3/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Injury, poisoning and procedural complications Fall	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
General disorders Fatigue	71.4% 5/7 • Number of events 6 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Musculoskeletal and connective tissue disorders Flank pain	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Flatulence	28.6% 2/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Gastric ulcer	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	28.6% 2/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Nervous system disorders Headache	28.6% 2/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Vascular disorders Hematoma	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Renal and urinary disorders Hematuria	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Vascular disorders Hot flashes	28.6% 2/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Vascular disorders Hypertension	14.3% 1/7 • Number of events 2 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Metabolism and nutrition disorders Hypoglycemia	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Infections and infestations Infections and infestations - Other, specify	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Psychiatric disorders Insomnia	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Psychiatric disorders Irritability	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
General disorders Localized edema	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Nervous system disorders Memory impairment	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Mucositis oral	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Musculoskeletal and connective tissue disorders Muscle cramp	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Musculoskeletal and connective tissue disorders Myalgia	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Skin and subcutaneous tissue disorders Nail ridging	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Respiratory, thoracic and mediastinal disorders Nasal congestion	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Nausea	57.1% 4/7 • Number of events 5 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Musculoskeletal and connective tissue disorders Neck pain	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Nervous system disorders Nervous system disorders - Other, specify	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Oral dysesthesia	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Infections and infestations Otitis externa	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
General disorders Pain	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Skin and subcutaneous tissue disorders Photosensitivity	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Respiratory, thoracic and mediastinal disorders Postnasal drip	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Nervous system disorders Presyncope	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Skin and subcutaneous tissue disorders Pruritus	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Psychiatric disorders Psychiatric disorders - Other, specify	14.3% 1/7 • Number of events 2 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Skin and subcutaneous tissue disorders Rash acneiform	14.3% 1/7 • Number of events 2 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Infections and infestations Skin infection	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Surgical and medical procedures Surgical and medical procedures - Other, specify	57.1% 4/7 • Number of events 11 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Nervous system disorders Tremor	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Infections and infestations Upper respiratory infection	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Infections and infestations Viremia	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Gastrointestinal disorders Vomiting	14.3% 1/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.
Investigations White blood cell decreased	28.6% 2/7 • From start of study treatment until 30 days after discontinuation of study treatment; max approximately 42 months Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.

Additional Information

Clinicaltrials.gov and CTRP Specialist

Huntsman Cancer Institute/University of Utah

Phone: 8012136215

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place