Trial Outcomes & Findings for Tipifarnib in Subjects With Myelodysplastic Syndromes (NCT NCT02779777)
NCT ID: NCT02779777
Last Updated: 2024-07-31
Results Overview
ORR was assessed by the investigator and included complete response (CR), partial response (PR), marrow complete remission (MR), and hematologic improvement (HI) according to the MDS International Working Group (IWG) criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
1 year
Results posted on
2024-07-31
Participant Flow
Subjects affected by myelodysplastic syndromes (MDS) were recruited across 2 sites in the United States between June 2016 and August 2018.
This study included a screening period, treatment period (28-day cycles until disease progression), end of treatment visit, follow-up visit (for subjects who terminated treatment for reasons other than death or disease progression), and follow-up contact (upon disease progression, all subjects were followed approximately every 12 weeks for survival and use of subsequent therapy until either death or accrual in the subject's study cohort was completed, whichever occurred first).
Participant milestones
| Measure |
Original Cohort
Subjects prior to Amendment 3 were considered to be the Original Cohort. Prior to Amendment 3 this was a non-randomized study with 900 twice daily (BID) (Days 1-7 and 15-21) in 28 day cycles, allowing for adjustments in dosing/schedule based on patient tolerability.
|
Regimen 1: Tipifarnib
600 mg twice daily (BID) for 7 days on Days 1-7 in 28 day cycles.
|
Regimen 2: Tipifarnib
300 mg BID for 21 days on Days 1-21 in 28 day cycles (ie, 3 weeks on/1 weeks off).
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
1
|
1
|
Reasons for withdrawal
| Measure |
Original Cohort
Subjects prior to Amendment 3 were considered to be the Original Cohort. Prior to Amendment 3 this was a non-randomized study with 900 twice daily (BID) (Days 1-7 and 15-21) in 28 day cycles, allowing for adjustments in dosing/schedule based on patient tolerability.
|
Regimen 1: Tipifarnib
600 mg twice daily (BID) for 7 days on Days 1-7 in 28 day cycles.
|
Regimen 2: Tipifarnib
300 mg BID for 21 days on Days 1-21 in 28 day cycles (ie, 3 weeks on/1 weeks off).
|
|---|---|---|---|
|
Overall Study
Disease Progression
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
3
|
1
|
0
|
|
Overall Study
Physician Decision
|
9
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Tipifarnib in Subjects With Myelodysplastic Syndromes
Baseline characteristics by cohort
| Measure |
Original Cohort
n=14 Participants
Subjects prior to Amendment 3 were considered to be the Original Cohort. Prior to Amendment 3 this was a non-randomized study with 900 twice daily (BID) (Days 1-7 and 15-21) in 28 day cycles, allowing for adjustments in dosing/schedule based on patient tolerability.
|
Regimen 1: Tipifarnib
n=1 Participants
600 mg BID for 7 days on Days 1-7 in 28 day cycles (ie, 1 week on/3 weeks off).
|
Regimen 2: Tipifarnib
n=1 Participants
300 mg BID for 21 days on Days 1-21 in 28 day cycles (ie, 3 weeks on/1 week off).
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.2 years
STANDARD_DEVIATION 7.5 • n=99 Participants
|
76.6 years
STANDARD_DEVIATION NA • n=107 Participants
|
68.9 years
STANDARD_DEVIATION NA • n=206 Participants
|
71.4 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 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
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
ECOG Performance Status
0
|
12 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
ECOG Performance Status
1
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
ECOG Performance Status
2
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Full analysis set (FAS) includes subjects enrolled in Protocol Amendment 3 (version 09 Jul 2017) and received at least one dose of tipifarnib.
ORR was assessed by the investigator and included complete response (CR), partial response (PR), marrow complete remission (MR), and hematologic improvement (HI) according to the MDS International Working Group (IWG) criteria.
Outcome measures
| Measure |
Original Cohort
Subjects prior to Amendment 3 were considered to be the Original Cohort. Prior to Amendment 3 this was a non-randomized study with 900 BID (Days 1-7 and 15-21) in 28 day cycles, allowing for adjustments in dosing/schedule based on patient tolerability.
|
Regimen 1: Tipifarnib
n=1 Participants
600 mg twice daily (BID) for 7 days on Days 1-7 in 28 day cycles.
|
Regimen 2: Tipifarnib
n=1 Participants
300 mg BID for 21 days on Days 1-21 in 28 day cycles.
|
|---|---|---|---|
|
Objective Response Rate (ORR)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: FAS includes subjects enrolled in Protocol Amendment 3 (version 09 Jul 2017) and received at least one dose of tipifarnib.
Rate of transfusion independence is defined as number of participants with transfusion independence at any response assessment over 1 year.
Outcome measures
| Measure |
Original Cohort
Subjects prior to Amendment 3 were considered to be the Original Cohort. Prior to Amendment 3 this was a non-randomized study with 900 BID (Days 1-7 and 15-21) in 28 day cycles, allowing for adjustments in dosing/schedule based on patient tolerability.
|
Regimen 1: Tipifarnib
n=1 Participants
600 mg twice daily (BID) for 7 days on Days 1-7 in 28 day cycles.
|
Regimen 2: Tipifarnib
n=1 Participants
300 mg BID for 21 days on Days 1-21 in 28 day cycles.
|
|---|---|---|---|
|
Rate of Transfusion Independence
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: FAS includes subjects enrolled in Protocol Amendment 3 (version 09 Jul 2017) and received at least one dose of tipifarnib.
Duration of transfusion independence is defined as the period of time where participants achieved transfusion independence.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: FAS includes subjects enrolled in Protocol Amendment 3 (version 09 Jul 2017) and received at least one dose of tipifarnib.
Number of subjects who experienced hematologic improvements (erythroid response, platelet response, or neutrophil response).
Outcome measures
| Measure |
Original Cohort
Subjects prior to Amendment 3 were considered to be the Original Cohort. Prior to Amendment 3 this was a non-randomized study with 900 BID (Days 1-7 and 15-21) in 28 day cycles, allowing for adjustments in dosing/schedule based on patient tolerability.
|
Regimen 1: Tipifarnib
n=1 Participants
600 mg twice daily (BID) for 7 days on Days 1-7 in 28 day cycles.
|
Regimen 2: Tipifarnib
n=1 Participants
300 mg BID for 21 days on Days 1-21 in 28 day cycles.
|
|---|---|---|---|
|
Hematologic Improvement
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: FAS includes subjects enrolled in Protocol Amendment 3 (version 09 Jul 2017) and received at least one dose of tipifarnib.
Duration of response is defined as the number of days from the start date of response (whichever response is achieved first) to the first date that progressive disease is objectively documented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: FAS includes subjects enrolled in Protocol Amendment 3 (version 09 Jul 2017) and received at least one dose of tipifarnib.
PFS is defined as the time (in months) from enrollment to either first observation of progressive disease or occurrence of death due to any cause within 1 year (approximately 4 time intervals for disease assessments) of either first administration of tipifarnib or the last disease assessment.
Outcome measures
| Measure |
Original Cohort
Subjects prior to Amendment 3 were considered to be the Original Cohort. Prior to Amendment 3 this was a non-randomized study with 900 BID (Days 1-7 and 15-21) in 28 day cycles, allowing for adjustments in dosing/schedule based on patient tolerability.
|
Regimen 1: Tipifarnib
n=1 Participants
600 mg twice daily (BID) for 7 days on Days 1-7 in 28 day cycles.
|
Regimen 2: Tipifarnib
n=1 Participants
300 mg BID for 21 days on Days 1-21 in 28 day cycles.
|
|---|---|---|---|
|
Progression-free Survival (PFS) at 1 Year
|
—
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: FAS includes subjects enrolled in Protocol Amendment 3 (version 09 Jul 2017) and received at least one dose of tipifarnib.
OS is defined as the time (in months) from enrollment to occurrence of death due to any cause within 1 year (approximately 4 time intervals for disease assessments) of either first administration of tipifarnib or the last disease assessment.
Outcome measures
| Measure |
Original Cohort
Subjects prior to Amendment 3 were considered to be the Original Cohort. Prior to Amendment 3 this was a non-randomized study with 900 BID (Days 1-7 and 15-21) in 28 day cycles, allowing for adjustments in dosing/schedule based on patient tolerability.
|
Regimen 1: Tipifarnib
n=1 Participants
600 mg twice daily (BID) for 7 days on Days 1-7 in 28 day cycles.
|
Regimen 2: Tipifarnib
n=1 Participants
300 mg BID for 21 days on Days 1-21 in 28 day cycles.
|
|---|---|---|---|
|
Overall Survival (OS) at 1 Year
|
—
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The All Subjects as Treated (ASaT) population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
TEAEs are defined as AEs that started on or after the first dose of study drug and within approximately 30 days of the last administration of study drug. AEs were summarized by the number and percentage of subjects who experienced the event, according to system organ class and preferred term. A subject reporting multiple cases of the same AE will be counted once within each system organ class and similarly counted once within each preferred term.
Outcome measures
| Measure |
Original Cohort
n=14 Participants
Subjects prior to Amendment 3 were considered to be the Original Cohort. Prior to Amendment 3 this was a non-randomized study with 900 BID (Days 1-7 and 15-21) in 28 day cycles, allowing for adjustments in dosing/schedule based on patient tolerability.
|
Regimen 1: Tipifarnib
n=1 Participants
600 mg twice daily (BID) for 7 days on Days 1-7 in 28 day cycles.
|
Regimen 2: Tipifarnib
n=1 Participants
300 mg BID for 21 days on Days 1-21 in 28 day cycles.
|
|---|---|---|---|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Subjects with one or more TEAE
|
14 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Subjects with one or more study drug-related TEAE
|
14 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Subjects with one or more serious TEAE
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Subjects with one or more study drug-related serious TEAE
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Original Cohort
Serious events: 7 serious events
Other events: 14 other events
Deaths: 0 deaths
Regimen 1: Tipifarnib
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Regimen 2: Tipifarnib
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Original Cohort
n=14 participants at risk
Subjects prior to Amendment 3 were considered to be the Original Cohort. Prior to Amendment 3 this was a non-randomized study with 900 BID (Days 1-7 and 15-21) in 28 day cycles, allowing for adjustments in dosing/schedule based on patient tolerability.
|
Regimen 1: Tipifarnib
n=1 participants at risk
600 mg BID for 7 days on Days 1-7 in 28 day cycles.
|
Regimen 2: Tipifarnib
n=1 participants at risk
300 mg BID for 21 days on Days 1-21 in 28 day cycles.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
2/14 • Number of events 3 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Cardiac disorders
Bradycardia
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Cardiac disorders
Palpitations
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Infections and infestations
Pneumonia
|
14.3%
2/14 • Number of events 2 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
General disorders
Pyrexia
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
Other adverse events
| Measure |
Original Cohort
n=14 participants at risk
Subjects prior to Amendment 3 were considered to be the Original Cohort. Prior to Amendment 3 this was a non-randomized study with 900 BID (Days 1-7 and 15-21) in 28 day cycles, allowing for adjustments in dosing/schedule based on patient tolerability.
|
Regimen 1: Tipifarnib
n=1 participants at risk
600 mg BID for 7 days on Days 1-7 in 28 day cycles.
|
Regimen 2: Tipifarnib
n=1 participants at risk
300 mg BID for 21 days on Days 1-21 in 28 day cycles.
|
|---|---|---|---|
|
Nervous system disorders
Tremor
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Psychiatric disorders
Confusional state
|
14.3%
2/14 • Number of events 2 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Renal and urinary disorders
Chronic kidney disease
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
2/14 • Number of events 2 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
2/14 • Number of events 2 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
2/14 • Number of events 2 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/14 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
100.0%
1/1 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
100.0%
1/1 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Nervous system disorders
Dizziness
|
21.4%
3/14 • Number of events 3 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
100.0%
1/1 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Nervous system disorders
Balance disorder
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
64.3%
9/14 • Number of events 9 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
100.0%
1/1 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Blood and lymphatic system disorders
Neutropenia
|
42.9%
6/14 • Number of events 6 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
100.0%
1/1 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
100.0%
1/1 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
2/14 • Number of events 2 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Eye disorders
Cataract
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Eye disorders
Periorbital oedema
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Gastrointestinal disorders
Nausea
|
28.6%
4/14 • Number of events 4 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
100.0%
1/1 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.4%
3/14 • Number of events 3 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
2/14 • Number of events 2 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
General disorders
Fatigue
|
35.7%
5/14 • Number of events 5 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
100.0%
1/1 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
General disorders
Chest pain
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
General disorders
Oedema peripheral
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Immune system disorders
Hypersensitivity
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Infections and infestations
Urinary tract infection
|
21.4%
3/14 • Number of events 3 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Infections and infestations
Cystitis
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Investigations
Weight decreased
|
21.4%
3/14 • Number of events 3 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Investigations
Blood creatinine increased
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.4%
3/14 • Number of events 3 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Metabolism and nutrition disorders
Increased appetite
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
|
Metabolism and nutrition disorders
Iron overload
|
7.1%
1/14 • Number of events 1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
0.00%
0/1 • 1 year
The ASaT population consisted of all enrolled subjects who received at least 1 dose of tipifarnib.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There are agreements in place between clinical trial sites and the Sponsor (or its agents) that govern discussion or publication of trial results by the sites or their employees after the trial is completed.
- Publication restrictions are in place
Restriction type: OTHER