Trial Outcomes & Findings for Tipifarnib and Etoposide in Treating Older Patients With Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia (NCT NCT00602771)
NCT ID: NCT00602771
Last Updated: 2014-10-09
Results Overview
Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/mcL and a platelet count of 100,000 mcL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. A CR must be confirmed 4 to 6 weeks after the initial documentation. If possible, at least one bone marrow biopsy should be performed to confirm the CR.
COMPLETED
PHASE2
84 participants
6 months
2014-10-09
Participant Flow
January 2008 and December 2009,
5 patients signed consent, but were deemed screen failures and did not begin study treatment
Participant milestones
| Measure |
Arm I
Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
|
Arm II (Closed to Accrual as of November 2008)
Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
21
|
|
Overall Study
COMPLETED
|
62
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tipifarnib and Etoposide in Treating Older Patients With Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Arm I
n=63 Participants
Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
|
Arm II (Closed to Accrual as of November 2008)
n=21 Participants
Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
63 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
84 Participants
n=35 Participants
|
|
Age, Continuous
|
76 years
STANDARD_DEVIATION 20 • n=39 Participants
|
78 years
STANDARD_DEVIATION 19 • n=41 Participants
|
76 years
STANDARD_DEVIATION 20 • n=35 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
53 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=39 Participants
|
21 participants
n=41 Participants
|
84 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 6 monthsBone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/mcL and a platelet count of 100,000 mcL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. A CR must be confirmed 4 to 6 weeks after the initial documentation. If possible, at least one bone marrow biopsy should be performed to confirm the CR.
Outcome measures
| Measure |
Arm I
n=15 Participants
Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
|
Arm II (Closed to Accrual as of November 2008)
n=6 Participants
Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
|
|---|---|---|
|
Complete Response
|
0 participants
|
0 participants
|
Adverse Events
Arm I
Arm II (Closed to Accrual as of November 2008)
Serious adverse events
| Measure |
Arm I
n=63 participants at risk
Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
|
Arm II (Closed to Accrual as of November 2008)
n=21 participants at risk
Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
|
|---|---|---|
|
General disorders
non-hematologic toxicities
|
6.3%
4/63 • Number of events 4
|
33.3%
7/21 • Number of events 7
|
|
Infections and infestations
Infections
|
7.9%
5/63 • Number of events 5
|
38.1%
8/21 • Number of events 8
|
Other adverse events
| Measure |
Arm I
n=63 participants at risk
Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
|
Arm II (Closed to Accrual as of November 2008)
n=21 participants at risk
Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
|
|---|---|---|
|
Nervous system disorders
Dose reduction
|
28.6%
18/63 • Number of events 18
|
28.6%
6/21 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60