Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)
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| ClinicalTrials.gov Identifier: NCT01179737 |
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Recruitment Status :
Terminated
(Study was terminated due to serious adverse event (SAE))
First Posted : August 11, 2010
Results First Posted : February 27, 2014
Last Update Posted : May 1, 2014
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Pulmonary Arterial Hypertension |
| Interventions |
Drug: Nilotinib Drug: Placebo to nilotinib |
| Enrollment | 23 |
Participant Flow
| Recruitment Details | 23 participants were enrolled into the study (15 in cohort 1; 8 in cohort 2) 8 participants completed cohort 1 and 6 of these participants moved into cohort 1expansion. Of the 5 participants that completed Cohort 1 expansion; 3 participants went into an Extension. None of the participants completed treatment as trial was terminated |
| Pre-assignment Details | Participants were randomized 6:1 ratio to nilotinib and placebo |
| Arm/Group Title | Cohort 1: Nilotinib | Cohort 1: Placebo | Cohort 2: Nilotinib | Cohort 2: Placebo |
|---|---|---|---|---|
 Arm/Group Description |
Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days. | Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days. | Participants were assigned to receive nilotinib 300 mg during 168 days | Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days |
| Period Title: Cohort 1 & Cohort 2 | ||||
| Started | 12 | 3 [1] | 4 | 4 |
| Completed | 7 | 1 | 0 | 0 |
| Not Completed | 5 | 2 | 4 | 4 |
| Reason Not Completed | ||||
| Adverse Event | 3 | 1 | 1 | 0 |
| Withdrew consent | 2 | 0 | 0 | 0 |
| Administrative problems | 0 | 0 | 2 | 4 |
| Death | 0 | 0 | 1 | 0 |
| Withdrew consent without EOS 1 visit | 0 | 1 | 0 | 0 |
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[1]
One patient was missing the end of study evaluation
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| Period Title: Cohort 1 & Cohort 2 Expansion | ||||
| Started | 5 [1] | 1 | 0 | 0 |
| Completed | 4 | 1 | 0 | 0 |
| Not Completed | 1 | 0 | 0 | 0 |
| Reason Not Completed | ||||
| Death | 1 | 0 | 0 | 0 |
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[1]
2 participants did not enroll in extension
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| Period Title: Extension | ||||
| Started | 3 [1] | 0 [2] | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 |
| Not Completed | 3 | 0 | 0 | 0 |
| Reason Not Completed | ||||
| The study was terminated | 3 | 0 | 0 | 0 |
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[1]
Two patients did not enrol in the extension
[2]
One patient did not enrol in the extension
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Baseline Characteristics
| Arm/Group Title | Cohort 1: Nilotinib | Cohort 1: Placebo | Cohort 2: Nilotinib | Cohort 2: Placebo | Total | |
|---|---|---|---|---|---|---|
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Arm/Group Description |
Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days. | Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days. | Participants were assigned to receive nilotinib 300 mg during 168 days | Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days | Total of all reporting groups | |
| Overall Number of Baseline Participants | 12 | 3 | 4 | 4 | 23 | |
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Baseline Analysis Population Description |
an end of study evaluation was only available for 14 of these patients
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 12 participants | 3 participants | 4 participants | 4 participants | 23 participants | |
| 52 (13.1) | 60 (6.1) | 31 (14.6) | 33 (10.2) | 32 (11.8) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 12 participants | 3 participants | 4 participants | 4 participants | 23 participants | |
| Female |
10 83.3%
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3 100.0%
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4 100.0%
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3 75.0%
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20 87.0%
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| Male |
2 16.7%
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0 0.0%
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0 0.0%
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1 25.0%
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3 13.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators 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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
Results Point of Contact
| Name/Title: | Study Director |
| Organization: | Novartis Pharnaceuticals |
| Phone: | 862-778-8300 |
| EMail: | trialandresults.registries@novartis.com |
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01179737 |
| Obsolete Identifiers: | NCT01531270 |
| Other Study ID Numbers: |
CAMN107X2201 2010-019883-36 ( EudraCT Number ) |
| First Submitted: | August 3, 2010 |
| First Posted: | August 11, 2010 |
| Results First Submitted: | January 14, 2014 |
| Results First Posted: | February 27, 2014 |
| Last Update Posted: | May 1, 2014 |