A Safety and Efficacy Study to Evaluate AMG 531 Treatment in Subject With Myelodysplastic Syndrome Receiving Revlimid
Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT00418665
Collaborator
(none)
39
5
46
Study Details
Study Description
Brief Summary
This is a dose and schedule finding study of AMG 531 designed to assess the activity of AMG 531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects with myelodysplastic syndrome (MDS) receiving lenalidomide. Subjects with MDS that are planned to receive at least four cycles of lenalidomide for treatment of their disease are appropriate to screen for this study.
All subjects meeting the eligibility criteria will receive lenalidomide 10 mg capsule by mouth daily every day of each 28-day cycle. Subjects will receive AMG 531 or placebo once a week by subcutaneous injection for 16 weeks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
39 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) Receiving Lenalidomide.
Study Start Date
:
Dec 1, 2006
Actual Primary Completion Date
:
Mar 1, 2009
Actual Study Completion Date
:
Oct 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 750 mcg AMG 531 750 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A) |
Biological: AMG 531
AMG 531 will be administered by subcutaneous injection at a dose of 500 or 750 μg.
|
| Placebo Comparator: Placebo Part B Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B) |
Drug: Placebo
Subjects in the control group will receive placebo via subcutaneous injection.
|
| Placebo Comparator: Placebo Part A Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A) |
Drug: Placebo
Subjects in the control group will receive placebo via subcutaneous injection.
|
| Active Comparator: 500 mcg AMG 531 500 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A) |
Biological: AMG 531
AMG 531 will be administered by subcutaneous injection at a dose of 500 or 750 μg.
|
| Active Comparator: 750 mcg AMG531 Part B 750 μg AMG 531 biweekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B) |
Biological: AMG 531
AMG 531 will be administered by subcutaneous injection at a dose of 500 or 750 μg.
|
Outcome Measures
Primary Outcome Measures
- Occurrence of a Clinically Significant Thrombocytopenic Event [Treatment period through interim follow-up visit (up to 16 weeks)]
Occurrence of one or more clinically significant thrombocytopenic events, defined as either Common Terminology Criteria for Adverse Events (CTCAE) v. 3 grade 3 or 4 thrombocytopenia starting from week 3 of cycle 1 or receipt of platelet transfusions starting from week 1 of cycle 1 and continuing through the end of treatment visit.
Secondary Outcome Measures
- Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia [Treatment period (up to 16 weeks)]
Occurrence of lenalidomide dose reduction and delay due to thrombocytopenia
- Achieving an Overall Response (Complete Response (CR) or Partial Response (PR)) Determined by the Investigator Based on Modified International Working Group 2006 Response Criteria Guidelines [Treatment period and post-treatment follow-up (up to 21 weeks)]
CR = decrease in bone marrow blast (≤5%) and improvement in peripheral blood counts (Hgb ≥ 11 g/dL, platelets ≥ 100x10^9/L, neutrophils ≥ 1x10^9/L, peripheral blasts=0%). PR = improvement in peripheral blood counts plus a decrease in bone marrow blasts ≥50% but not ≤5, or decrease in International Prognostic Scoring System score.
- Platelet Transfusion [Treatment period (up to 16 weeks)]
Occurrence of one or more platelet transfusions during the treatment period
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosis of MDS by bone marrow biopsy based on the World Health Organization (WHO) classification
-
Low or Intermediate-1 risk category MDS using the IPSS
-
Planned to receive lenalidomide 10 mg capsule by mouth daily for all 28 days of each cycle for at least 4 cycles
-
Eastern Cooperative Oncology (ECOG) performance status of 0-2
-
Subjects must be at least 18 years of age or older
Exclusion Criteria:
-
Prior exposure to >3 cycles of lenalidomide
-
Exposure to lenalidomide within the last 30 days
-
Prior history of leukemia or aplastic anemia
-
Prior history of stem cell transplantation
-
Prior malignancy (other than in situ cervical cancer or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for 3 years before randomization
-
Active or uncontrolled infections
-
Unstable angina, congestive heart failure [NYHA > class II], uncontrolled hypertension [diastolic > 100 mmHg], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction
-
History of arterial thrombosis ( eg, stroke or transient ischemic attack) in the past year
-
History of venous thrombosis in the past year
-
Received IL-11 within 4 weeks of screening
-
Less than 4 weeks since receipt of any investigational drug or device
-
Have previously received any other thrombopoietic growth factor
-
Pregnant or breast feeding
-
Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
-
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:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00418665
Other Study ID Numbers:
- 20060102
First Posted:
Jan 5, 2007
Last Update Posted:
Jan 24, 2011
Last Verified:
Jan 1, 2011
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled from 14 March 2007 through 24 July 2008 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo | Romiplostim (AMG 531) 500 μg | Romiplostim (AMG 531) 750 μg |
|---|---|---|---|
| Arm/Group Description | Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks | Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks | Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks |
| Period Title: Treatment Period | |||
| STARTED | 12 | 14 | 13 |
| Received Study Medication | 11 | 13 | 13 |
| COMPLETED | 7 | 8 | 9 |
| NOT COMPLETED | 5 | 6 | 4 |
| Period Title: Treatment Period | |||
| STARTED | 7 | 8 | 9 |
| COMPLETED | 1 | 4 | 7 |
| NOT COMPLETED | 6 | 4 | 2 |
Baseline Characteristics
| Arm/Group Title | Placebo | Romiplostim 500 μg | Romiplostim 750 μg | Total |
|---|---|---|---|---|
| Arm/Group Description | Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks | Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks | Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks | Total of all reporting groups |
| Overall Participants | 12 | 14 | 13 | 39 |
| Age (Years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Years] |
73.2
(15.0)
|
72.9
(11.4)
|
66.7
(9.4)
|
70.9
(12.1)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
4
33.3%
|
6
42.9%
|
5
38.5%
|
15
38.5%
|
| Male |
8
66.7%
|
8
57.1%
|
8
61.5%
|
24
61.5%
|
| Race/Ethnicity, Customized (Number) [Number] | ||||
| White or Caucasian |
11
91.7%
|
13
92.9%
|
12
92.3%
|
36
92.3%
|
| Black or African American |
0
0%
|
0
0%
|
1
7.7%
|
1
2.6%
|
| Hispanic or Latino |
1
8.3%
|
1
7.1%
|
0
0%
|
2
5.1%
|
| International Prognostic Scoring System (IPSS) Score (Number) [Number] | ||||
| 0 |
4
33.3%
|
4
28.6%
|
6
46.2%
|
14
35.9%
|
| 0.5 |
3
25%
|
6
42.9%
|
4
30.8%
|
13
33.3%
|
| 1.0 |
3
25%
|
2
14.3%
|
3
23.1%
|
8
20.5%
|
| >1.0 |
1
8.3%
|
1
7.1%
|
0
0%
|
2
5.1%
|
| Missing |
1
8.3%
|
1
7.1%
|
0
0%
|
2
5.1%
|
Outcome Measures
| Title | Occurrence of a Clinically Significant Thrombocytopenic Event |
|---|---|
| Description | Occurrence of one or more clinically significant thrombocytopenic events, defined as either Common Terminology Criteria for Adverse Events (CTCAE) v. 3 grade 3 or 4 thrombocytopenia starting from week 3 of cycle 1 or receipt of platelet transfusions starting from week 1 of cycle 1 and continuing through the end of treatment visit. |
| Time Frame | Treatment period through interim follow-up visit (up to 16 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set, composed of all randomized participants |
| Arm/Group Title | Placebo | Romiplostim 500 μg | Romiplostim 750 μg |
|---|---|---|---|
| Arm/Group Description | Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks | Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks | Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks |
| Measure Participants | 12 | 14 | 13 |
| Number [Participants] |
8
66.7%
|
4
28.6%
|
8
61.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Romiplostim 750 μg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.600 | |
| Confidence Interval |
() 95% 0.070 to 5.136 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Romiplostim/placebo | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Romiplostim 500 μg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.154 | |
| Confidence Interval |
() 95% 0.022 to 1.071 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Romiplostim/placebo | |
| Title | Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia |
|---|---|
| Description | Occurrence of lenalidomide dose reduction and delay due to thrombocytopenia |
| Time Frame | Treatment period (up to 16 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set, composed of all randomized participants |
| Arm/Group Title | Placebo | Romiplostim 500 μg | Romiplostim 750 μg |
|---|---|---|---|
| Arm/Group Description | Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks | Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks | Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks |
| Measure Participants | 12 | 14 | 13 |
| Number [Participants] |
6
50%
|
5
35.7%
|
2
15.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Romiplostim 750 μg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio, log |
| Estimated Value | 0.154 | |
| Confidence Interval |
() 95% 0.022 to 1.071 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Romiplostim/placebo | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Romiplostim 500 μg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.514 | |
| Confidence Interval |
() 95% 0.102 to 2.589 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Romiplostim/placebo | |
| Title | Achieving an Overall Response (Complete Response (CR) or Partial Response (PR)) Determined by the Investigator Based on Modified International Working Group 2006 Response Criteria Guidelines |
|---|---|
| Description | CR = decrease in bone marrow blast (≤5%) and improvement in peripheral blood counts (Hgb ≥ 11 g/dL, platelets ≥ 100x10^9/L, neutrophils ≥ 1x10^9/L, peripheral blasts=0%). PR = improvement in peripheral blood counts plus a decrease in bone marrow blasts ≥50% but not ≤5, or decrease in International Prognostic Scoring System score. |
| Time Frame | Treatment period and post-treatment follow-up (up to 21 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set, composed of all randomized participants |
| Arm/Group Title | Placebo | Romiplostim 500 μg | Romiplostim 750 μg |
|---|---|---|---|
| Arm/Group Description | Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks | Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks | Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks |
| Measure Participants | 12 | 14 | 13 |
| Number [Participants] |
1
8.3%
|
2
14.3%
|
3
23.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Romiplostim 750 μg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 3.000 | |
| Confidence Interval |
() 95% 0.227 to 39.608 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Romiplostim/placebo | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Romiplostim 500 μg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.714 | |
| Confidence Interval |
() 95% 0.144 to 20.473 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Romiplostim/placebo | |
| Title | Platelet Transfusion |
|---|---|
| Description | Occurrence of one or more platelet transfusions during the treatment period |
| Time Frame | Treatment period (up to 16 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set, composed of all randomized participants |
| Arm/Group Title | Placebo | Romiplostim 500 μg | Romiplostim 750 μg |
|---|---|---|---|
| Arm/Group Description | Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks | Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks | Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks |
| Measure Participants | 12 | 14 | 13 |
| Number [Participants] |
4
33.3%
|
4
28.6%
|
4
30.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Romiplostim 750 μg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.911 | |
| Confidence Interval |
() 95% 0.097 to 8.529 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Romiplostim/placebo | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Romiplostim 500 μg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.866 | |
| Confidence Interval |
() 95% 0.175 to 4.278 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Romiplostim/placebo | |
Adverse Events
| Time Frame | Up to 21 weeks | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively. | |||||
| Arm/Group Title | Placebo | Romiplostim 500 µg | Romiplostim 750 µg | |||
| Arm/Group Description | ||||||
All Cause Mortality |
||||||
| Placebo | Romiplostim 500 µg | Romiplostim 750 µg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Placebo | Romiplostim 500 µg | Romiplostim 750 µg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/9 (66.7%) | 5/14 (35.7%) | 4/14 (28.6%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 0/9 (0%) | 1/14 (7.1%) | 2/14 (14.3%) | |||
| Febrile neutropenia | 0/9 (0%) | 1/14 (7.1%) | 1/14 (7.1%) | |||
| Leukopenia | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Neutropenia | 1/9 (11.1%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Thrombocytopenia | 0/9 (0%) | 3/14 (21.4%) | 1/14 (7.1%) | |||
| Cardiac disorders | ||||||
| Angina pectoris | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Bradycardia | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Gastrointestinal disorders | ||||||
| Diarrhoea | 1/9 (11.1%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Nausea | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Vomiting | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| General disorders | ||||||
| Pyrexia | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Infections and infestations | ||||||
| Bacteraemia | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Cellulitis | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Staphylococcal sepsis | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Pelvic fracture | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Spinal fracture | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Hyperkalaemia | 0/9 (0%) | 1/14 (7.1%) | 1/14 (7.1%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Back pain | 0/9 (0%) | 2/14 (14.3%) | 0/14 (0%) | |||
| Bone pain | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Muscle spasms | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Muscular weakness | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Nervous system disorders | ||||||
| Cerebrovascular accident | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Renal and urinary disorders | ||||||
| Renal failure acute | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Acute respiratory failure | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Vascular disorders | ||||||
| Thrombophlebitis | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Placebo | Romiplostim 500 µg | Romiplostim 750 µg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/9 (88.9%) | 14/14 (100%) | 14/14 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 0/9 (0%) | 1/14 (7.1%) | 1/14 (7.1%) | |||
| Febrile neutropenia | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Haematotoxicity | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Leukopenia | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Lymph node pain | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Lymphadenopathy | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Neutropenia | 3/9 (33.3%) | 1/14 (7.1%) | 4/14 (28.6%) | |||
| Pancytopenia | 1/9 (11.1%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Thrombocytopenia | 3/9 (33.3%) | 4/14 (28.6%) | 2/14 (14.3%) | |||
| Thrombocytosis | 0/9 (0%) | 2/14 (14.3%) | 1/14 (7.1%) | |||
| Cardiac disorders | ||||||
| Atrial fibrillation | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Ear congestion | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Ear pain | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Tinnitus | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal discomfort | 1/9 (11.1%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Abdominal pain | 1/9 (11.1%) | 1/14 (7.1%) | 1/14 (7.1%) | |||
| Abdominal pain lower | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Abdominal pain upper | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Constipation | 0/9 (0%) | 5/14 (35.7%) | 1/14 (7.1%) | |||
| Diarrhoea | 4/9 (44.4%) | 4/14 (28.6%) | 5/14 (35.7%) | |||
| Dry mouth | 0/9 (0%) | 2/14 (14.3%) | 0/14 (0%) | |||
| Dyspepsia | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Faeces hard | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Frequent bowel movements | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Gastrooesophageal reflux disease | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Gingival bleeding | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Haematochezia | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Lip ulceration | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Nausea | 0/9 (0%) | 3/14 (21.4%) | 5/14 (35.7%) | |||
| Oral pain | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| General disorders | ||||||
| Asthenia | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Catheter site haemorrhage | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Catheter site pain | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Chills | 1/9 (11.1%) | 1/14 (7.1%) | 1/14 (7.1%) | |||
| Fatigue | 1/9 (11.1%) | 4/14 (28.6%) | 8/14 (57.1%) | |||
| Feeling cold | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Gait disturbance | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Non-cardiac chest pain | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Oedema | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Oedema peripheral | 3/9 (33.3%) | 5/14 (35.7%) | 3/14 (21.4%) | |||
| Pyrexia | 2/9 (22.2%) | 1/14 (7.1%) | 2/14 (14.3%) | |||
| Ulcer haemorrhage | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Infections and infestations | ||||||
| Bacteraemia | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Cellulitis | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Conjunctivitis infective | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Gastroenteritis viral | 0/9 (0%) | 2/14 (14.3%) | 0/14 (0%) | |||
| Herpes simplex | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Herpes virus infection | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Localised infection | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Nasopharyngitis | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Oral herpes | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Sinusitis | 0/9 (0%) | 0/14 (0%) | 2/14 (14.3%) | |||
| Urinary tract infection | 0/9 (0%) | 3/14 (21.4%) | 0/14 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Arthropod bite | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Contusion | 0/9 (0%) | 0/14 (0%) | 2/14 (14.3%) | |||
| Facial bones fracture | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Fall | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Muscle strain | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Tooth fracture | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Transfusion reaction | 1/9 (11.1%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Investigations | ||||||
| Blood creatinine increased | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Blood potassium decreased | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Cardiac murmur | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Culture urine positive | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Haemoglobin decreased | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Platelet count increased | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Weight decreased | 1/9 (11.1%) | 0/14 (0%) | 2/14 (14.3%) | |||
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 0/9 (0%) | 3/14 (21.4%) | 3/14 (21.4%) | |||
| Dehydration | 2/9 (22.2%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Fluid retention | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Hyperglycaemia | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Hypoglycaemia | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Hypokalaemia | 1/9 (11.1%) | 1/14 (7.1%) | 2/14 (14.3%) | |||
| Hypomagnesaemia | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Hypovolaemia | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Vitamin B12 deficiency | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 0/9 (0%) | 0/14 (0%) | 3/14 (21.4%) | |||
| Back pain | 1/9 (11.1%) | 2/14 (14.3%) | 0/14 (0%) | |||
| Bursitis | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Joint stiffness | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Joint swelling | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Muscle spasms | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Musculoskeletal pain | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Musculoskeletal stiffness | 0/9 (0%) | 2/14 (14.3%) | 0/14 (0%) | |||
| Myalgia | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Myositis | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Pain in extremity | 0/9 (0%) | 1/14 (7.1%) | 3/14 (21.4%) | |||
| Pain in jaw | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Basal cell carcinoma | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Nervous system disorders | ||||||
| Dizziness | 3/9 (33.3%) | 2/14 (14.3%) | 1/14 (7.1%) | |||
| Head discomfort | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Headache | 0/9 (0%) | 1/14 (7.1%) | 3/14 (21.4%) | |||
| Restless legs syndrome | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Sciatica | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Tremor | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Psychiatric disorders | ||||||
| Anxiety | 0/9 (0%) | 2/14 (14.3%) | 2/14 (14.3%) | |||
| Depression | 0/9 (0%) | 1/14 (7.1%) | 2/14 (14.3%) | |||
| Insomnia | 0/9 (0%) | 4/14 (28.6%) | 1/14 (7.1%) | |||
| Mood altered | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Renal and urinary disorders | ||||||
| Pollakiuria | 0/9 (0%) | 2/14 (14.3%) | 0/14 (0%) | |||
| Proteinuria | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Reproductive system and breast disorders | ||||||
| Vaginal haemorrhage | 1/9 (11.1%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Chronic obstructive pulmonary disease | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Cough | 1/9 (11.1%) | 2/14 (14.3%) | 2/14 (14.3%) | |||
| Dyspnoea | 0/9 (0%) | 1/14 (7.1%) | 3/14 (21.4%) | |||
| Dyspnoea exertional | 0/9 (0%) | 1/14 (7.1%) | 1/14 (7.1%) | |||
| Epistaxis | 0/9 (0%) | 3/14 (21.4%) | 1/14 (7.1%) | |||
| Nasal discomfort | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Oropharyngeal pain | 1/9 (11.1%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Paranasal sinus hypersecretion | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Pleural effusion | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Rhinitis allergic | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Sinus congestion | 0/9 (0%) | 2/14 (14.3%) | 0/14 (0%) | |||
| Sleep apnoea syndrome | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Acne | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Blood blister | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Cold sweat | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Dry skin | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Ecchymosis | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Exfoliative rash | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Haemorrhage subcutaneous | 0/9 (0%) | 0/14 (0%) | 2/14 (14.3%) | |||
| Hyperhidrosis | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Night sweats | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Periorbital oedema | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Petechiae | 0/9 (0%) | 0/14 (0%) | 2/14 (14.3%) | |||
| Photosensitivity reaction | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Pruritus | 1/9 (11.1%) | 2/14 (14.3%) | 4/14 (28.6%) | |||
| Rash | 2/9 (22.2%) | 5/14 (35.7%) | 5/14 (35.7%) | |||
| Rash erythematous | 1/9 (11.1%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Rash macular | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Rash pruritic | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Skin exfoliation | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Urticaria | 0/9 (0%) | 1/14 (7.1%) | 1/14 (7.1%) | |||
| Vascular disorders | ||||||
| Haematoma | 1/9 (11.1%) | 0/14 (0%) | 0/14 (0%) | |||
| Hot flush | 0/9 (0%) | 1/14 (7.1%) | 0/14 (0%) | |||
| Hypotension | 0/9 (0%) | 0/14 (0%) | 1/14 (7.1%) | |||
| Pallor | 0/9 (0%) | 1/14 (7.1%) | 0/14 (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:
NCT00418665
Other Study ID Numbers:
- 20060102
First Posted:
Jan 5, 2007
Last Update Posted:
Jan 24, 2011
Last Verified:
Jan 1, 2011