Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only
Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT00950911
Collaborator
(none)
35
17
1
33
2.1
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab in the Treatment of Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
Study Start Date
:
Jul 1, 2009
Actual Primary Completion Date
:
Feb 1, 2012
Actual Study Completion Date
:
Apr 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: amg 162
120 mg SC injection of denosumab Q4W until the subject has access to commercially available product or for up to 2 years, which ever comes first.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Survived [2 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subjects currently enrolled in study 20050103, 20050136, or 20050244
-
Subjects must sign the informed consent before any study specific procedures are performed
Exclusion Criteria:
-
Developed sensitivity to mammalian cell derived drug products during the 20050103, 20050136, or 20050244 study
-
Currently receiving any unapproved investigational product other than denosumab
-
Subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment
-
Subject (male or female) is not willing to use 2 highly effective contraception during treatment and for 7 months (women) or 10 months (men) after the end of treatment
-
Male subject with a pregnant partner who is not willing to use a condom during treatment and for additional 10 months after the end of treatment
-
Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Jindrichuv Hradec | Czech Republic | 377 01 | |
| 2 | Research Site | Kromeriz | Czech Republic | 767 55 | |
| 3 | Research Site | Olomouc | Czech Republic | 775 20 | |
| 4 | Research Site | Praha 1 | Czech Republic | 110 00 | |
| 5 | Research Site | Praha 4 | Czech Republic | 140 00 | |
| 6 | Research Site | Praha 4 | Czech Republic | 140 44 | |
| 7 | Research Site | Praha 5 | Czech Republic | 150 06 | |
| 8 | Research Site | Praha 6 | Czech Republic | 160 00 | |
| 9 | Research Site | Zlin | Czech Republic | 762 75 | |
| 10 | Research Site | Chichester | United Kingdom | PO19 4SE | |
| 11 | Research Site | Leeds | United Kingdom | LS9 7TF | |
| 12 | Research Site | London | United Kingdom | SE1 9RT | |
| 13 | Research Site | London | United Kingdom | W2 1NY | |
| 14 | Research Site | Manchester | United Kingdom | M20 4BX | |
| 15 | Research Site | Northwood | United Kingdom | HA6 2RN | |
| 16 | Research Site | Peterborough | United Kingdom | PE3 9GZ | |
| 17 | Research Site | York | United Kingdom | YO31 8HE |
Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT00950911
Other Study ID Numbers:
- 20080540
First Posted:
Aug 3, 2009
Last Update Posted:
Feb 11, 2014
Last Verified:
Dec 1, 2013
Keywords provided by Amgen
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subjects recuited in this open-label extension study were those who were enrolled in the 2 parent (phase 3, randomized, double-blind, active-controlled) studies 20050103 (NCT00321620) or 20050136 (NCT00321464) at sites in the Czech Republic and United Kingdom. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W | Denosumab 120 mg Q4W / Denosumab 120 mg Q4W |
|---|---|---|
| Arm/Group Description | This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study. | This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study. |
| Period Title: Overall Study | ||
| STARTED | 17 | 18 |
| COMPLETED | 5 | 3 |
| NOT COMPLETED | 12 | 15 |
Baseline Characteristics
| Arm/Group Title | Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W | Denosumab 120 mg Q4W / Denosumab 120 mg Q4W | Total |
|---|---|---|---|
| Arm/Group Description | This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study. | This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study. | Total of all reporting groups |
| Overall Participants | 17 | 18 | 35 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
61.6
(11.1)
|
61.1
(13.0)
|
61.3
(11.9)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
7
41.2%
|
6
33.3%
|
13
37.1%
|
| Male |
10
58.8%
|
12
66.7%
|
22
62.9%
|
| Race/Ethnicity, Customized (Number) [Number] | |||
| White or Caucasian |
17
100%
|
17
94.4%
|
34
97.1%
|
| Black or African American |
0
0%
|
1
5.6%
|
1
2.9%
|
Outcome Measures
| Title | Number of Participants Survived |
|---|---|
| Description | |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W | Denosumab 120 mg Q4W / Denosumab 120 mg Q4W |
|---|---|---|
| Arm/Group Description | This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study. | This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study. |
| Measure Participants | 17 | 18 |
| Number [Participants] |
13
76.5%
|
12
66.7%
|
Adverse Events
| Time Frame | 2 years | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. | |||
| Arm/Group Title | Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W | Denosumab 120 mg Q4W / Denosumab 120 mg Q4W | ||
| Arm/Group Description | This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study. | This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study. | ||
All Cause Mortality |
||||
| Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W | Denosumab 120 mg Q4W / Denosumab 120 mg Q4W | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W | Denosumab 120 mg Q4W / Denosumab 120 mg Q4W | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/17 (47.1%) | 10/18 (55.6%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 0/17 (0%) | 1/18 (5.6%) | ||
| Cardiac disorders | ||||
| Atrial fibrillation | 1/17 (5.9%) | 0/18 (0%) | ||
| Cardiac failure | 1/17 (5.9%) | 0/18 (0%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 0/17 (0%) | 1/18 (5.6%) | ||
| Vomiting | 0/17 (0%) | 1/18 (5.6%) | ||
| General disorders | ||||
| Death | 1/17 (5.9%) | 0/18 (0%) | ||
| Hepatobiliary disorders | ||||
| Hepatic failure | 0/17 (0%) | 1/18 (5.6%) | ||
| Infections and infestations | ||||
| Urosepsis | 0/17 (0%) | 1/18 (5.6%) | ||
| Injury, poisoning and procedural complications | ||||
| Lumbar vertebral fracture | 0/17 (0%) | 1/18 (5.6%) | ||
| Thoracic vertebral fracture | 0/17 (0%) | 1/18 (5.6%) | ||
| Investigations | ||||
| Platelet count decreased | 0/17 (0%) | 1/18 (5.6%) | ||
| Metabolism and nutrition disorders | ||||
| Cachexia | 1/17 (5.9%) | 2/18 (11.1%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Osteonecrosis | 0/17 (0%) | 1/18 (5.6%) | ||
| Osteonecrosis of jaw | 2/17 (11.8%) | 1/18 (5.6%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Metastases to meninges | 0/17 (0%) | 1/18 (5.6%) | ||
| Neoplasm malignant | 0/17 (0%) | 1/18 (5.6%) | ||
| Prostate cancer metastatic | 0/17 (0%) | 1/18 (5.6%) | ||
| Nervous system disorders | ||||
| Convulsion | 1/17 (5.9%) | 0/18 (0%) | ||
| Grand mal convulsion | 0/17 (0%) | 1/18 (5.6%) | ||
| Partial seizures | 0/17 (0%) | 1/18 (5.6%) | ||
| Sciatica | 0/17 (0%) | 1/18 (5.6%) | ||
| Renal and urinary disorders | ||||
| Haematuria | 0/17 (0%) | 1/18 (5.6%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Pulmonary embolism | 0/17 (0%) | 1/18 (5.6%) | ||
| Surgical and medical procedures | ||||
| Hip arthroplasty | 1/17 (5.9%) | 0/18 (0%) | ||
| Vascular disorders | ||||
| Jugular vein thrombosis | 1/17 (5.9%) | 0/18 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W | Denosumab 120 mg Q4W / Denosumab 120 mg Q4W | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/17 (76.5%) | 13/18 (72.2%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/17 (5.9%) | 6/18 (33.3%) | ||
| Leukopenia | 1/17 (5.9%) | 0/18 (0%) | ||
| Lymphadenopathy | 0/17 (0%) | 1/18 (5.6%) | ||
| Neutropenia | 3/17 (17.6%) | 1/18 (5.6%) | ||
| Thrombocytopenia | 1/17 (5.9%) | 0/18 (0%) | ||
| Cardiac disorders | ||||
| Atrial fibrillation | 0/17 (0%) | 1/18 (5.6%) | ||
| Palpitations | 1/17 (5.9%) | 0/18 (0%) | ||
| Ear and labyrinth disorders | ||||
| Ear haemorrhage | 1/17 (5.9%) | 0/18 (0%) | ||
| Endocrine disorders | ||||
| Cushingoid | 1/17 (5.9%) | 1/18 (5.6%) | ||
| Eye disorders | ||||
| Eye pain | 1/17 (5.9%) | 0/18 (0%) | ||
| Eye swelling | 1/17 (5.9%) | 0/18 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal rigidity | 0/17 (0%) | 1/18 (5.6%) | ||
| Constipation | 0/17 (0%) | 4/18 (22.2%) | ||
| Diarrhoea | 1/17 (5.9%) | 2/18 (11.1%) | ||
| Duodenitis | 1/17 (5.9%) | 0/18 (0%) | ||
| Dyspepsia | 1/17 (5.9%) | 1/18 (5.6%) | ||
| Gastric disorder | 0/17 (0%) | 1/18 (5.6%) | ||
| Gingival bleeding | 0/17 (0%) | 1/18 (5.6%) | ||
| Gingival pain | 0/17 (0%) | 1/18 (5.6%) | ||
| Gingivitis | 0/17 (0%) | 1/18 (5.6%) | ||
| Haemorrhoids | 1/17 (5.9%) | 0/18 (0%) | ||
| Nausea | 1/17 (5.9%) | 5/18 (27.8%) | ||
| Oral disorder | 1/17 (5.9%) | 0/18 (0%) | ||
| Proctalgia | 1/17 (5.9%) | 0/18 (0%) | ||
| Sensitivity of teeth | 0/17 (0%) | 1/18 (5.6%) | ||
| Stomatitis | 1/17 (5.9%) | 2/18 (11.1%) | ||
| Tooth loss | 1/17 (5.9%) | 0/18 (0%) | ||
| Toothache | 1/17 (5.9%) | 0/18 (0%) | ||
| Vomiting | 2/17 (11.8%) | 3/18 (16.7%) | ||
| General disorders | ||||
| Chest pain | 2/17 (11.8%) | 0/18 (0%) | ||
| Face oedema | 1/17 (5.9%) | 0/18 (0%) | ||
| Facial pain | 1/17 (5.9%) | 0/18 (0%) | ||
| Fatigue | 3/17 (17.6%) | 6/18 (33.3%) | ||
| Feeling hot | 1/17 (5.9%) | 0/18 (0%) | ||
| Gait disturbance | 1/17 (5.9%) | 0/18 (0%) | ||
| General physical health deterioration | 1/17 (5.9%) | 2/18 (11.1%) | ||
| Local swelling | 1/17 (5.9%) | 0/18 (0%) | ||
| Localised oedema | 1/17 (5.9%) | 0/18 (0%) | ||
| Mucosal necrosis | 1/17 (5.9%) | 0/18 (0%) | ||
| Oedema | 1/17 (5.9%) | 0/18 (0%) | ||
| Oedema peripheral | 2/17 (11.8%) | 0/18 (0%) | ||
| Pain | 2/17 (11.8%) | 2/18 (11.1%) | ||
| Pyrexia | 1/17 (5.9%) | 0/18 (0%) | ||
| Submandibular mass | 0/17 (0%) | 1/18 (5.6%) | ||
| Swelling | 1/17 (5.9%) | 0/18 (0%) | ||
| Hepatobiliary disorders | ||||
| Liver disorder | 1/17 (5.9%) | 0/18 (0%) | ||
| Immune system disorders | ||||
| Immunodeficiency | 1/17 (5.9%) | 0/18 (0%) | ||
| Infections and infestations | ||||
| Borrelia infection | 1/17 (5.9%) | 0/18 (0%) | ||
| Cellulitis | 1/17 (5.9%) | 0/18 (0%) | ||
| Cystitis | 1/17 (5.9%) | 0/18 (0%) | ||
| Erysipelas | 0/17 (0%) | 1/18 (5.6%) | ||
| Herpes zoster | 1/17 (5.9%) | 1/18 (5.6%) | ||
| Influenza | 1/17 (5.9%) | 0/18 (0%) | ||
| Localised infection | 1/17 (5.9%) | 0/18 (0%) | ||
| Nasopharyngitis | 1/17 (5.9%) | 0/18 (0%) | ||
| Oral candidiasis | 0/17 (0%) | 2/18 (11.1%) | ||
| Oral fungal infection | 1/17 (5.9%) | 0/18 (0%) | ||
| Oral herpes | 0/17 (0%) | 1/18 (5.6%) | ||
| Pharyngitis | 2/17 (11.8%) | 0/18 (0%) | ||
| Pneumonia | 1/17 (5.9%) | 0/18 (0%) | ||
| Postoperative wound infection | 0/17 (0%) | 1/18 (5.6%) | ||
| Skin infection | 0/17 (0%) | 1/18 (5.6%) | ||
| Tooth abscess | 1/17 (5.9%) | 0/18 (0%) | ||
| Upper respiratory tract infection | 0/17 (0%) | 1/18 (5.6%) | ||
| Urinary tract infection | 0/17 (0%) | 1/18 (5.6%) | ||
| Injury, poisoning and procedural complications | ||||
| Fall | 0/17 (0%) | 1/18 (5.6%) | ||
| Fractured coccyx | 1/17 (5.9%) | 0/18 (0%) | ||
| Lumbar vertebral fracture | 1/17 (5.9%) | 0/18 (0%) | ||
| Post procedural complication | 1/17 (5.9%) | 0/18 (0%) | ||
| Procedural pain | 1/17 (5.9%) | 1/18 (5.6%) | ||
| Tooth fracture | 1/17 (5.9%) | 0/18 (0%) | ||
| Investigations | ||||
| Eastern Cooperative Oncology Group performance status worsened | 0/17 (0%) | 1/18 (5.6%) | ||
| Ejection fraction decreased | 0/17 (0%) | 1/18 (5.6%) | ||
| Haemoglobin decreased | 0/17 (0%) | 2/18 (11.1%) | ||
| Platelet count decreased | 1/17 (5.9%) | 0/18 (0%) | ||
| Weight decreased | 1/17 (5.9%) | 2/18 (11.1%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 1/17 (5.9%) | 4/18 (22.2%) | ||
| Hyperglycaemia | 1/17 (5.9%) | 0/18 (0%) | ||
| Hypocalcaemia | 1/17 (5.9%) | 2/18 (11.1%) | ||
| Hypokalaemia | 2/17 (11.8%) | 0/18 (0%) | ||
| Hypoproteinaemia | 1/17 (5.9%) | 0/18 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 4/17 (23.5%) | 0/18 (0%) | ||
| Back pain | 2/17 (11.8%) | 4/18 (22.2%) | ||
| Bone disorder | 1/17 (5.9%) | 0/18 (0%) | ||
| Bone pain | 3/17 (17.6%) | 2/18 (11.1%) | ||
| Muscular weakness | 1/17 (5.9%) | 3/18 (16.7%) | ||
| Musculoskeletal chest pain | 0/17 (0%) | 2/18 (11.1%) | ||
| Musculoskeletal pain | 1/17 (5.9%) | 1/18 (5.6%) | ||
| Neck pain | 2/17 (11.8%) | 0/18 (0%) | ||
| Osteitis | 0/17 (0%) | 1/18 (5.6%) | ||
| Pain in extremity | 1/17 (5.9%) | 1/18 (5.6%) | ||
| Pain in jaw | 0/17 (0%) | 2/18 (11.1%) | ||
| Periostitis | 1/17 (5.9%) | 0/18 (0%) | ||
| Sensation of heaviness | 1/17 (5.9%) | 0/18 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Basal cell carcinoma | 1/17 (5.9%) | 0/18 (0%) | ||
| Tumour flare | 0/17 (0%) | 1/18 (5.6%) | ||
| Nervous system disorders | ||||
| Brain oedema | 1/17 (5.9%) | 0/18 (0%) | ||
| Convulsion | 1/17 (5.9%) | 0/18 (0%) | ||
| Coordination abnormal | 0/17 (0%) | 1/18 (5.6%) | ||
| Dizziness | 1/17 (5.9%) | 1/18 (5.6%) | ||
| Dysarthria | 1/17 (5.9%) | 0/18 (0%) | ||
| Dysgeusia | 0/17 (0%) | 2/18 (11.1%) | ||
| Headache | 2/17 (11.8%) | 0/18 (0%) | ||
| Hypoaesthesia | 2/17 (11.8%) | 0/18 (0%) | ||
| Lethargy | 1/17 (5.9%) | 2/18 (11.1%) | ||
| Neuropathy peripheral | 1/17 (5.9%) | 2/18 (11.1%) | ||
| Paraesthesia | 2/17 (11.8%) | 2/18 (11.1%) | ||
| Post herpetic neuralgia | 0/17 (0%) | 1/18 (5.6%) | ||
| Psychiatric disorders | ||||
| Anxiety | 0/17 (0%) | 1/18 (5.6%) | ||
| Confusional state | 1/17 (5.9%) | 0/18 (0%) | ||
| Depression | 1/17 (5.9%) | 0/18 (0%) | ||
| Insomnia | 1/17 (5.9%) | 1/18 (5.6%) | ||
| Renal and urinary disorders | ||||
| Bladder obstruction | 0/17 (0%) | 1/18 (5.6%) | ||
| Urinary incontinence | 0/17 (0%) | 1/18 (5.6%) | ||
| Reproductive system and breast disorders | ||||
| Penile oedema | 1/17 (5.9%) | 0/18 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 2/17 (11.8%) | 3/18 (16.7%) | ||
| Dyspnoea | 0/17 (0%) | 2/18 (11.1%) | ||
| Dyspnoea exertional | 0/17 (0%) | 1/18 (5.6%) | ||
| Epistaxis | 1/17 (5.9%) | 0/18 (0%) | ||
| Hydrothorax | 1/17 (5.9%) | 0/18 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 1/17 (5.9%) | 1/18 (5.6%) | ||
| Dermatitis allergic | 0/17 (0%) | 1/18 (5.6%) | ||
| Dry skin | 1/17 (5.9%) | 0/18 (0%) | ||
| Eczema | 0/17 (0%) | 1/18 (5.6%) | ||
| Erythema | 0/17 (0%) | 1/18 (5.6%) | ||
| Hyperhidrosis | 0/17 (0%) | 1/18 (5.6%) | ||
| Nail disorder | 1/17 (5.9%) | 0/18 (0%) | ||
| Nail dystrophy | 0/17 (0%) | 2/18 (11.1%) | ||
| Pain of skin | 0/17 (0%) | 1/18 (5.6%) | ||
| Photosensitivity allergic reaction | 1/17 (5.9%) | 0/18 (0%) | ||
| Skin disorder | 0/17 (0%) | 1/18 (5.6%) | ||
| Skin hyperpigmentation | 1/17 (5.9%) | 0/18 (0%) | ||
| Skin lesion | 1/17 (5.9%) | 0/18 (0%) | ||
| Social circumstances | ||||
| Denture wearer | 1/17 (5.9%) | 0/18 (0%) | ||
| Surgical and medical procedures | ||||
| Tooth extraction | 1/17 (5.9%) | 0/18 (0%) | ||
| Vascular disorders | ||||
| Hypertension | 1/17 (5.9%) | 0/18 (0%) | ||
| Lymphoedema | 1/17 (5.9%) | 0/18 (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 aftercompletion. 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 multicenter 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:
Amgen
ClinicalTrials.gov Identifier:
NCT00950911
Other Study ID Numbers:
- 20080540
First Posted:
Aug 3, 2009
Last Update Posted:
Feb 11, 2014
Last Verified:
Dec 1, 2013