Trial Outcomes & Findings for Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission (NCT NCT00093470)
NCT ID: NCT00093470
Last Updated: 2024-03-20
Results Overview
Disease-free survival (DFS) is defined as the time from randomization to relapse or death without relapse.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
144 participants
Primary outcome timeframe
Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.
Results posted on
2024-03-20
Participant Flow
This study was activated on August 18, 2004, suspended between August 8, 2007 and February 6, 2008 for toxicity and safety evaluation, and closed on December 7, 2009 with a total of 144 patients accrued.
Participant milestones
| Measure |
Arm A (Tipifarnib)
Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Tipifarnib: Given PO
|
Arm B (Clinical Observation)
Patients undergo observation only.
Clinical Observation: Undergo observation
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
71
|
|
Overall Study
Treated
|
72
|
71
|
|
Overall Study
Patients With Toxicity Assessment
|
72
|
69
|
|
Overall Study
COMPLETED
|
0
|
71
|
|
Overall Study
NOT COMPLETED
|
73
|
0
|
Reasons for withdrawal
| Measure |
Arm A (Tipifarnib)
Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Tipifarnib: Given PO
|
Arm B (Clinical Observation)
Patients undergo observation only.
Clinical Observation: Undergo observation
|
|---|---|---|
|
Overall Study
Disease progression
|
39
|
0
|
|
Overall Study
Adverse Event
|
15
|
0
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
0
|
|
Overall Study
Alternative therapy
|
2
|
0
|
|
Overall Study
Other complicating disease
|
3
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Never started treatment
|
1
|
0
|
|
Overall Study
ANC < 1000 on day 1 of cycle 1
|
1
|
0
|
Baseline Characteristics
Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission
Baseline characteristics by cohort
| Measure |
Arm A (Tipifarnib)
n=73 Participants
Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Tipifarnib: Given PO
|
Arm B (Clinical Observation)
n=71 Participants
Patients undergo observation only.
Clinical Observation: Undergo observation
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
n=5 Participants
|
69 years
n=7 Participants
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.Population: All randomized patients
Disease-free survival (DFS) is defined as the time from randomization to relapse or death without relapse.
Outcome measures
| Measure |
Arm A (Tipifarnib)
n=73 Participants
Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Clinical Observation)
n=71 Participants
Patients undergo observation only.
|
|---|---|---|
|
Disease-free Survival
|
8.87 months
Interval 5.85 to 13.34
|
5.26 months
Interval 3.88 to 7.56
|
SECONDARY outcome
Timeframe: Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.Population: All randomized patients
Overall survival (OS) is defined as the time from randomization to death from any cause.
Outcome measures
| Measure |
Arm A (Tipifarnib)
n=73 Participants
Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Clinical Observation)
n=71 Participants
Patients undergo observation only.
|
|---|---|---|
|
Overall Survival
|
16.36 months
Interval 12.26 to 25.2
|
9.27 months
Interval 8.41 to 19.88
|
Adverse Events
Arm A (Tipifarnib)
Serious events: 52 serious events
Other events: 50 other events
Deaths: 0 deaths
Arm B (Clinical Observation)
Serious events: 8 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Tipifarnib)
n=72 participants at risk
Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Clinical Observation)
n=69 participants at risk
Patients undergo observation only.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
9/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.9%
2/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
White blood cell decreased
|
40.3%
29/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.9%
2/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophil count decreased
|
34.7%
25/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelet count decreased
|
50.0%
36/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
8.7%
6/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Acute coronary syndrome
|
1.4%
1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
1.4%
1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.8%
2/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.4%
1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Catheter related infection
|
1.4%
1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Lung infection
|
1.4%
1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Peripheral nerve infection
|
1.4%
1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Sinusitis
|
1.4%
1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
1.4%
1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
GGT increased
|
1.4%
1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.4%
1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Confusion
|
2.8%
2/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Agitation
|
1.4%
1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.4%
1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Psychosis
|
1.4%
1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Eye disorders
Eye disorders - Other, specify
|
1.4%
1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
1.4%
1/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
Other adverse events
| Measure |
Arm A (Tipifarnib)
n=72 participants at risk
Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Clinical Observation)
n=69 participants at risk
Patients undergo observation only.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
55.6%
40/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
18.8%
13/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
White blood cell decreased
|
58.3%
42/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
17.4%
12/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophil count decreased
|
5.6%
4/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelet count decreased
|
54.2%
39/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
15.9%
11/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
6.9%
5/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.4%
1/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.9%
5/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
4/72 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/69 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
Additional Information
Study statistician
ECOG-ACRIN Statistical Office
Phone: 617-632-6012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60