UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008314 |
|---|---|
| Receipt number | R000009785 |
| Scientific Title | A phase II clinical trial of denosumab treatment for advanced non-small cell lung cancer with bone metastasis |
| Date of disclosure of the study information | 2012/07/03 |
| Last modified on | 2012/07/02 08:59:42 |
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Basic information
Public title
A phase II clinical trial of denosumab treatment for advanced non-small cell lung cancer with bone metastasis
Acronym
A phase II clinical trial of denosumab treatment for advanced non-small cell lung cancer with bone metastasis
Scientific Title
A phase II clinical trial of denosumab treatment for advanced non-small cell lung cancer with bone metastasis
Scientific Title:Acronym
A phase II clinical trial of denosumab treatment for advanced non-small cell lung cancer with bone metastasis
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of denosumab in non-small cell lung cancer patients with bone metastasis. To analyze the correlation between the efficacy and bone metabolic markers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of skeletal-related events (SRE).
Key secondary outcomes
1) Time to develop SRE
2) Incidence of adverse events
3) Progression free survival
4) Overall survival
5) Response rate
6) Rate of change in bone metabolic markers
7) Rate of change in pain score
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
denosumab
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically confirmed NSCLC
2) Patients have radiologically apparent bone metastasis
3) Aged >=18
4) PS of 0-2
5) Adequate organ functions
6) Written informed consent
Key exclusion criteria
1) Hypersensitivity to denosumab
2) Need of emergency treatment for bone metastasis by radiotherapy or surgery
3) Need of treatment for hypercalcemia
4) Prior use of bisphosphonates
5) Symptomatic brain metastasis
6) Active severe infections
7) Severe odontopathy
8) Interstitial pneumonitis
9) Active concomitant malignancy
10) Pregnant or lactating
11) Uncontrolled heart disease, hepatic disease, diabetes mellitus, bleeding, etc.
12) Problematic psychiatric disease
13) Inappropriate patients for this study judged by the physicians
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Ishii |
Organization
Dokkyo Medical University
Division name
Department of Pulmonary Medicine and Clinivcal Immunology
Zip code
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Dokkyo Medical University
Division name
Department of Pulmonary Medicine and Clinivcal Immunology
Zip code
Address
TEL
0282-87-2151
Homepage URL
Sponsor or person
Institute
Dokkyo Medical University
Department of Pulmonary Medicine and Clinivcal Immunology
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
Department of Pulmonary Medicine and Clinical Immunology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
TOTORO
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2012 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 02 | Day |
Last modified on
| 2012 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009785
