Trial Outcomes & Findings for Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) (NCT NCT00519090)
NCT ID: NCT00519090
Last Updated: 2011-11-07
Results Overview
Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
6 participants
Primary outcome timeframe
12 months
Results posted on
2011-11-07
Participant Flow
Participant milestones
| Measure |
Nilotinib (AMN107)
Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
|
Imatinib
Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
|
Overall Study
COMPLETED
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Baseline characteristics by cohort
| Measure |
Nilotinib (AMN107)
n=2 Participants
Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
|
Imatinib
n=4 Participants
Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age Continuous
|
69.5 years
STANDARD_DEVIATION 4.949747 • n=5 Participants
|
45.5 years
STANDARD_DEVIATION 12.06924 • n=7 Participants
|
54 years
STANDARD_DEVIATION 15.6812 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsDue to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsPopulation: The trial was terminated early, so only 6 patients were enrolled.
Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
Outcome measures
Outcome data not reported
Adverse Events
Nilotinib (AMN107)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Imatinib
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nilotinib (AMN107)
n=2 participants at risk
Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
|
Imatinib
n=4 participants at risk
Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
1/2
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
50.0%
1/2
|
0.00%
0/4
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
1/2
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Face Oedema
|
0.00%
0/2
|
25.0%
1/4
|
|
General disorders
Fatigue
|
50.0%
1/2
|
0.00%
0/4
|
|
Nervous system disorders
Headache
|
0.00%
0/2
|
50.0%
2/4
|
|
Hepatobiliary disorders
Hepatic function abnormality
|
50.0%
1/2
|
0.00%
0/4
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/2
|
25.0%
1/4
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
0.00%
0/2
|
25.0%
1/4
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2
|
25.0%
1/4
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2
|
25.0%
1/4
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2
|
50.0%
2/4
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
1/2
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
50.0%
1/2
|
25.0%
1/4
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2
|
25.0%
1/4
|
|
Eye disorders
Periorbital Oedema
|
0.00%
0/2
|
50.0%
2/4
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
1/2
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2
|
50.0%
2/4
|
|
Metabolism and nutrition disorders
Weight decrease
|
50.0%
1/2
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Weight increase
|
0.00%
0/2
|
25.0%
1/4
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER