A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma
Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT00283439
Collaborator
(none)
39
1
35
Study Details
Study Description
Brief Summary
The purpose of this study is to identify a well-tolerated, effective dose and schedule of AMG 531 for the treatment of Chemotherapy Induced Thrombocytopenia (CIT) in subjects with lymphoma receiving multi-cycle chemotherapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
39 participants
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
An Open Label Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Severe Thrombocytopenia Due to Multi-Cycle Chemotherapy in Adult Subjects With Lymphoma.
Study Start Date
:
Oct 1, 2005
Actual Primary Completion Date
:
May 1, 2008
Actual Study Completion Date
:
Sep 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Arm: AMG 531 Dose-Escalating Cohort Study
|
Biological: AMG 531
Planned Cohorts:
100 mcg,
300 mcg,
700 mcg,
1000 mcg;
Optional Cohorts:
cohort expansion,
schedule change,
new dose
|
Outcome Measures
Primary Outcome Measures
- Change in Platelet Nadir [32 weeks]
Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.
Secondary Outcome Measures
- Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia [32 weeks]
Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L, and <25 x 10^9/L)
- Duration of Grade 3 or 4 Thrombocytopenia [32 weeks]
Duration of grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L and <25 x 10^9/L, respectively)
- Percentage of Subjects That Received Platelet Transfusions [32 weeks]
Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Histologically confirmed Hodgkin's lymphoma or Non-Hodgkin's lymphoma receiving Q14, Q21, or Q28 day CHOP, ICE, ESHAP, or DHAP chemotherapy; with or without Rituximab
-
Has adequate bone marrow function; platelet count > 100 x 109/L on the day of initiation of the on study chemotherapy of the next treatment cycle and absolute neutrophil count, ANC > or = 1 x 109/L, and hemoglobin > or = 9.5 g/dL
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
-
Has adequate liver function
-
must be able to receive the same chemotherapy regimen during the first treatment cycle as was received during the prior qualifying cycle
-
must experience Common Terminology Criteria (CTC) grade 3 or 4 thrombocytopenia (platelet count < 50 x 10^9/L) as a result of the chemotherapy administered in the cycle immediately preceding study entry
-
has serum creatinine concentration < or = 2 mg/dl
Exclusion Criteria:
-
More that 1 prior relapse chemotherapy regimen
-
Sepsis, disseminated coagulation or any other condition that may exacerbate thrombocytopenia
-
Significant bleeding (CTC grade 3 or 4)
-
History of thromboembolic disease
-
Subjects who are identified by clinical history and/or serological testing to have either acute or chronic hepatitis B or C infection or to be HIV positive
-
Use of any nitrosourea or mitomycin-C
-
Has received any thrombocytopenic growth factor
-
Has received a marrow or peripheral blood stem cell infusion
-
Known hypersensitivity to any recombinant E. coli-derived product
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- AmgenTrials clinical trials website
- Notice regarding posted summaries of trial results
- FDA-approved Drug Labeling
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00283439
Other Study ID Numbers:
- 20050144
First Posted:
Jan 30, 2006
Last Update Posted:
Jun 20, 2011
Last Verified:
Jun 1, 2011
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled from 15 March 2006 through 28 April 2008 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Romiplostim 100 µg | Romiplostim 300 µg | Romiplostim 700 µg | Romiplostim 1000 µg |
|---|---|---|---|---|
| Arm/Group Description | Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy | Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy | Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy | Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy |
| Period Title: Overall Study | ||||
| STARTED | 8 | 11 | 11 | 9 |
| COMPLETED | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 8 | 11 | 11 | 9 |
Baseline Characteristics
| Arm/Group Title | Romiplostim 100 µg | Romiplostim 300 µg | Romiplostim 700 µg | Romiplostim 1000 µg | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy | Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy | Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy | Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy | Total of all reporting groups |
| Overall Participants | 8 | 11 | 11 | 9 | 39 |
| Age (Year) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Year] |
61.3
(6.2)
|
58.1
(9.5)
|
54.0
(16.3)
|
59.9
(10.6)
|
58.0
(11.5)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
3
37.5%
|
3
27.3%
|
4
36.4%
|
5
55.6%
|
15
38.5%
|
| Male |
5
62.5%
|
8
72.7%
|
7
63.6%
|
4
44.4%
|
24
61.5%
|
| Race/Ethnicity, Customized (Participant) [Number] | |||||
| White or Caucasian |
6
|
10
|
10
|
8
|
34
|
| Black or African American |
0
|
0
|
1
|
1
|
2
|
| Hispanic or Latino |
2
|
1
|
0
|
0
|
3
|
Outcome Measures
| Title | Change in Platelet Nadir |
|---|---|
| Description | Change in platelet nadir from the previous qualifying cycle to the first treatment cycle. |
| Time Frame | 32 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol. |
| Arm/Group Title | Romiplostim 100 µg | Romiplostim 300 µg | Romiplostim 700 µg | Romiplostim 1000 µg |
|---|---|---|---|---|
| Arm/Group Description | Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy | Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy | Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy | Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy |
| Measure Participants | 8 | 11 | 10 | 9 |
| Mean (Standard Error) [10^9/L] |
17.1
(8.3)
|
11.2
(6.1)
|
5.1
(6.1)
|
-5.2
(7.8)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Romiplostim 100 µg, Romiplostim 1000 µg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9654 |
| Comments | One-sided test | |
| Method | Satterhwaite t-test | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Romiplostim 100 µg, Romiplostim 700 µg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8690 |
| Comments | One-sided test | |
| Method | Satterhwaite t-test | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Romiplostim 100 µg, Romiplostim 300 µg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7133 |
| Comments | One-sided test | |
| Method | Satterhwaite t-test | |
| Comments | ||
| Title | Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia |
|---|---|
| Description | Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L, and <25 x 10^9/L) |
| Time Frame | 32 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol. |
| Arm/Group Title | Romiplostim 100 µg | Romiplostim 300 µg | Romiplostim 700 µg | Romiplostim 1000 µg |
|---|---|---|---|---|
| Arm/Group Description | Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy | Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy | Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy | Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy |
| Measure Participants | 8 | 11 | 10 | 9 |
| Number [Percentage of participants] |
62.5
781.3%
|
81.8
743.6%
|
80.0
727.3%
|
88.9
987.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Romiplostim 100 µg, Romiplostim 1000 µg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.294 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Romiplostim 100 µg, Romiplostim 700 µg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.608 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Romiplostim 100 µg, Romiplostim 300 µg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.603 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Duration of Grade 3 or 4 Thrombocytopenia |
|---|---|
| Description | Duration of grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L and <25 x 10^9/L, respectively) |
| Time Frame | 32 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol. |
| Arm/Group Title | Romiplostim 100 µg | Romiplostim 300 µg | Romiplostim 700 µg | Romiplostim 1000 µg |
|---|---|---|---|---|
| Arm/Group Description | Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy | Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy | Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy | Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy |
| Measure Participants | 8 | 11 | 10 | 9 |
| Mean (Standard Error) [Day] |
3.9
(1.3)
|
3.6
(0.9)
|
6.0
(1.5)
|
8.3
(2.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Romiplostim 100 µg, Romiplostim 1000 µg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.091 |
| Comments | ||
| Method | Satterhwaite t-test | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Romiplostim 100 µg, Romiplostim 700 µg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.300 |
| Comments | ||
| Method | Satterhwaite t-test | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Romiplostim 100 µg, Romiplostim 300 µg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.881 |
| Comments | ||
| Method | Satterhwaite t-test | |
| Comments | ||
| Title | Percentage of Subjects That Received Platelet Transfusions |
|---|---|
| Description | Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle |
| Time Frame | 32 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol. |
| Arm/Group Title | Romiplostim 100 µg | Romiplostim 300 µg | Romiplostim 700 µg | Romiplostim 1000 µg |
|---|---|---|---|---|
| Arm/Group Description | Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy | Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy | Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy | Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy |
| Measure Participants | 8 | 11 | 10 | 9 |
| Number [Percentage of participants] |
12.5
156.3%
|
0.0
0%
|
30.0
272.7%
|
33.3
370%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Romiplostim 100 µg, Romiplostim 1000 µg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.576 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Romiplostim 100 µg, Romiplostim 700 µg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.588 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Romiplostim 100 µg, Romiplostim 300 µg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.421 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Adverse Events
| Time Frame | From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. | |||||||
| Arm/Group Title | Romiplostim 100 µg | Romiplostim 300 µg | Romiplostim 700 µg | Romiplostim 1000 µg | ||||
| Arm/Group Description | ||||||||
All Cause Mortality |
||||||||
| Romiplostim 100 µg | Romiplostim 300 µg | Romiplostim 700 µg | Romiplostim 1000 µg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Romiplostim 100 µg | Romiplostim 300 µg | Romiplostim 700 µg | Romiplostim 1000 µg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 1/11 (9.1%) | 3/11 (27.3%) | 3/9 (33.3%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Febrile neutropenia | 0/8 (0%) | 1/11 (9.1%) | 1/11 (9.1%) | 2/9 (22.2%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 1/9 (11.1%) | ||||
| Gastrointestinal haemorrhage | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/9 (0%) | ||||
| General disorders | ||||||||
| Mucosal inflammation | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Infections and infestations | ||||||||
| Bacteraemia | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Clostridium difficile colitis | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Device related infection | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Staphylococcal infection | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/9 (0%) | ||||
| Upper respiratory tract infection | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Urinary tract infection | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Nervous system disorders | ||||||||
| Convulsion | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/9 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Renal failure acute | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Hypoxia | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Romiplostim 100 µg | Romiplostim 300 µg | Romiplostim 700 µg | Romiplostim 1000 µg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/8 (75%) | 9/11 (81.8%) | 7/11 (63.6%) | 9/9 (100%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 1/8 (12.5%) | 3/11 (27.3%) | 0/11 (0%) | 3/9 (33.3%) | ||||
| Neutropenia | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 3/9 (33.3%) | ||||
| Thrombocytopenia | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 2/9 (22.2%) | ||||
| Cardiac disorders | ||||||||
| Diastolic dysfunction | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Palpitations | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/9 (0%) | ||||
| Ear and labyrinth disorders | ||||||||
| Ear pain | 1/8 (12.5%) | 0/11 (0%) | 0/11 (0%) | 0/9 (0%) | ||||
| Tinnitus | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Vertigo | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Eye disorders | ||||||||
| Vision blurred | 0/8 (0%) | 1/11 (9.1%) | 1/11 (9.1%) | 0/9 (0%) | ||||
| Visual disturbance | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal discomfort | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Abdominal pain | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/9 (0%) | ||||
| Constipation | 0/8 (0%) | 2/11 (18.2%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Diarrhoea | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Dysphagia | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Gastric haemorrhage | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Haemorrhoids | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/9 (0%) | ||||
| Hyperchlorhydria | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Nausea | 0/8 (0%) | 5/11 (45.5%) | 1/11 (9.1%) | 1/9 (11.1%) | ||||
| Oesophagitis | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Rectal fissure | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Stomatitis | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Vomiting | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 1/9 (11.1%) | ||||
| General disorders | ||||||||
| Asthenia | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Catheter site pain | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 1/9 (11.1%) | ||||
| Catheter site related reaction | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Fatigue | 1/8 (12.5%) | 2/11 (18.2%) | 1/11 (9.1%) | 4/9 (44.4%) | ||||
| Influenza like illness | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Oedema peripheral | 1/8 (12.5%) | 0/11 (0%) | 0/11 (0%) | 3/9 (33.3%) | ||||
| Pain | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Pyrexia | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 2/9 (22.2%) | ||||
| Infections and infestations | ||||||||
| Cellulitis | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Folliculitis | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Oral candidiasis | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Rhinitis | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Upper respiratory tract infection | 1/8 (12.5%) | 0/11 (0%) | 0/11 (0%) | 0/9 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Arthropod bite | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/9 (0%) | ||||
| Back injury | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Contusion | 1/8 (12.5%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Excoriation | 1/8 (12.5%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Investigations | ||||||||
| Blood alkaline phosphatase increased | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Electrocardiogram QT prolonged | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Weight decreased | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Hypokalaemia | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 3/9 (33.3%) | ||||
| Hypomagnesaemia | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 1/9 (11.1%) | ||||
| Hypophosphataemia | 0/8 (0%) | 0/11 (0%) | 2/11 (18.2%) | 0/9 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/9 (0%) | ||||
| Back pain | 1/8 (12.5%) | 2/11 (18.2%) | 0/11 (0%) | 0/9 (0%) | ||||
| Bone pain | 0/8 (0%) | 2/11 (18.2%) | 0/11 (0%) | 0/9 (0%) | ||||
| Groin pain | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Muscle spasms | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Musculoskeletal pain | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Neck pain | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Pain in extremity | 1/8 (12.5%) | 0/11 (0%) | 0/11 (0%) | 2/9 (22.2%) | ||||
| Pain in jaw | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Nervous system disorders | ||||||||
| Dizziness | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 1/9 (11.1%) | ||||
| Headache | 1/8 (12.5%) | 1/11 (9.1%) | 1/11 (9.1%) | 0/9 (0%) | ||||
| Neuropathy peripheral | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/9 (0%) | ||||
| Paraesthesia | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Peripheral sensory neuropathy | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Tremor | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Psychiatric disorders | ||||||||
| Anxiety | 1/8 (12.5%) | 0/11 (0%) | 0/11 (0%) | 0/9 (0%) | ||||
| Depression | 1/8 (12.5%) | 0/11 (0%) | 1/11 (9.1%) | 0/9 (0%) | ||||
| Insomnia | 2/8 (25%) | 0/11 (0%) | 0/11 (0%) | 0/9 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Chromaturia | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Dysuria | 1/8 (12.5%) | 0/11 (0%) | 0/11 (0%) | 2/9 (22.2%) | ||||
| Haematuria | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Nocturia | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Pollakiuria | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Urine flow decreased | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Reproductive system and breast disorders | ||||||||
| Penile oedema | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 1/8 (12.5%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Dyspnoea exertional | 1/8 (12.5%) | 0/11 (0%) | 0/11 (0%) | 0/9 (0%) | ||||
| Epistaxis | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 2/9 (22.2%) | ||||
| Nasal congestion | 0/8 (0%) | 2/11 (18.2%) | 0/11 (0%) | 0/9 (0%) | ||||
| Pharyngolaryngeal pain | 1/8 (12.5%) | 0/11 (0%) | 0/11 (0%) | 0/9 (0%) | ||||
| Productive cough | 1/8 (12.5%) | 0/11 (0%) | 0/11 (0%) | 0/9 (0%) | ||||
| Rhinorrhoea | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 1/9 (11.1%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Alopecia | 2/8 (25%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Ecchymosis | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Increased tendency to bruise | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Palmar-plantar erythrodysaesthesia syndrome | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Petechiae | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/9 (0%) | ||||
| Rash | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Skin lesion | 0/8 (0%) | 0/11 (0%) | 0/11 (0%) | 1/9 (11.1%) | ||||
| Surgical and medical procedures | ||||||||
| Haematopoietic stem cell mobilisation | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/9 (0%) | ||||
| Vascular disorders | ||||||||
| Flushing | 0/8 (0%) | 1/11 (9.1%) | 0/11 (0%) | 0/9 (0%) | ||||
| Hypotension | 0/8 (0%) | 0/11 (0%) | 1/11 (9.1%) | 0/9 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Amgen Inc. |
| Phone | 866-572-6436 |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00283439
Other Study ID Numbers:
- 20050144
First Posted:
Jan 30, 2006
Last Update Posted:
Jun 20, 2011
Last Verified:
Jun 1, 2011