Solid TumorPhase 4NCT02101164
Evaluate Time Associated With the Preparation & Administration of Denosumab/Pamidronate in Patients With Solid Tumors and Metastatic Bone Disease
A Phase 4 study testing denosumab and pamidronate in people with Solid Tumor and Metastatic Bone Disease, run by Amgen.
Trial summary
This study will estimate the total time for the preparation and administration of denosumab and the total time for the preparation and administration of pamidronate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Metastatic Bone Disease
- What is being tested?
- denosumab and pamidronate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Nov 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of metastatic bone disease secondary to a solid tumor (eg, breast cancer, lung cancer, etc).
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subject is one of the following:
- being considered for pamidronate IV infusions or denosumab SC injections for treatment of metastatic bone disease (prescribed per Canadian product monograph); OR
- scheduled to receive pamidronate IV infusions or denosumab SC injections for treatment of metastatic bone disease (prescribed per Canadian product monograph); OR
- currently receiving pamidronate IV infusions or denosumab SC injections for treatment of metastatic bone disease AND has received no more than 4 prior administration of either product combined (prescribed per Canadian product monograph).
- Subject has a serum calcium or albumin-adjusted serum calcium ≥ 2.0 mmol/L (8.0 mg/dL) and ≤ 2.9 mmol/L (11.5 mg/dL)
Who cannot join
- Diagnosis with metastatic bone disease secondary to multiple myeloma or prostate cancer.
- Severe renal impairment (creatinine clearance < 30 mL/min)
- Subject is being considered for ambulatory pamidronate administration using an infuser device (ie, "baby bottle").
- A known active infection with Hepatitis B virus or Hepatitis C virus.
- Subject has known positive results for human immunodeficiency virus (HIV).Subject has a history of other malignancy within the past 5 years, other than:
- Malignancy treated with curative intent and with no known active disease present for ≥ 5 years before enrollment and felt to be at low risk for recurrence by the treating physician
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- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated cervical carcinoma in situ without evidence of disease
- Adequately treated breast ductal carcinoma in situ without evidence of disease
- Prostatic intraepithelial neoplasia without evidence of prostate cancer
- Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
- Subject has a history or current evidence of osteonecrosis/osteomyelitis of the jaw, active dental or jaw condition that requires oral surgery, non-healed dental/oral surgery, or planned invasive dental procedure over the course of the study.
About this study
Official title: An Open-Label, Multicentre Trial to Evaluate the Time Associated With the Preparation and Administration of Denosumab and Pamidronate in Subjects With Solid Tumors and Metastatic Bone Disease in Canada
This study will estimate the total time for the preparation and administration of denosumab and the total time for the preparation and administration of pamidronate.
- Conditions
- Solid Tumor, Metastatic Bone Disease
- Being tested
- denosumab, pamidronate
- Medical subject headings
- Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
denosumabBiological
Also called XGEVA
Treatment Group A - 120 mg SC dose every 4 weeks at Day 1 and week 5 Treatment Group B - 120 mg SC dose every 4 weeks at Week 9 and Week 13
pamidronateDrug
Also called Aredia
Treatment Group A - 90 mg IV dose every 4 weeks at Week 9 and Week 13 Treatment Group B - 90 mg IV dose every 4 weeks at Day 1 and Week 5
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Active comparator | 1 dose of denosumab every 4 weeks for 2 doses, followed by 1 dose of pamidronate every 4 weeks for 2 doses. Receives: Biological: denosumab; Drug: pamidronate |
| Treatment Group B | Active comparator | 1 dose of pamidronate every 4 weeks for 2 doses, followed by 1 dose of denosumab every 4 weeks for 2 doses. Receives: Biological: denosumab; Drug: pamidronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total duration (in hours, minutes and seconds) for investigational product preparation and administration
Measured: Day 1
Total duration (in hours, minutes and seconds) for investigational product preparation and administration
Measured: Week 5
Total duration (in hours, minutes and seconds) for investigational product preparation and administration
Measured: Week 9
Total duration (in hours, minutes and seconds) for investigational product preparation and administration
Measured: Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101164
- Sponsor's protocol ID
- 20120127
- Status last verified
- Jan 2015
- First submitted
- 12 Mar 2014
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicentre Trial to Evaluate the Time Associated With the Preparation and Administration of Denosumab and Pamidronate in Subjects With Solid Tumors and Metastatic Bone Disease in Canada
- ClinicalTrials.gov ID
- NCT02101164
- Acronym / sponsor ID
- 20120127
- Conditions
- Solid Tumor, Metastatic Bone Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will estimate the total time for the preparation and administration of denosumab and the total time for the preparation and administration of pamidronate.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Active comparator | Biological: denosumab, Drug: pamidronate1 dose of denosumab every 4 weeks for 2 doses, followed by 1 dose of pamidronate every 4 weeks for 2 doses. |
| Treatment Group B | Active comparator | Biological: denosumab, Drug: pamidronate1 dose of pamidronate every 4 weeks for 2 doses, followed by 1 dose of denosumab every 4 weeks for 2 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of metastatic bone disease secondary to a solid tumor (eg, breast cancer, lung cancer, etc).
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subject is one of the following:
- Subject has a serum calcium or albumin-adjusted serum calcium ≥ 2.0 mmol/L (8.0 mg/dL) and ≤ 2.9 mmol/L (11.5 mg/dL)
Key exclusion criteria (12 listed)
- Diagnosis with metastatic bone disease secondary to multiple myeloma or prostate cancer.
- Severe renal impairment (creatinine clearance < 30 mL/min)
- Subject is being considered for ambulatory pamidronate administration using an infuser device (ie, "baby bottle").
- A known active infection with Hepatitis B virus or Hepatitis C virus.
- Subject has known positive results for human immunodeficiency virus (HIV).Subject has a history of other malignancy within the past 5 years, other than:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| denosumabAlso: XGEVATreatment Group A - 120 mg SC dose every 4 weeks at Day 1 and week 5 Treatment Group B - 120 mg SC dose every 4 weeks at Week 9 and Week 13 | Biological | Treatment Group A, Treatment Group B |
| pamidronateAlso: ArediaTreatment Group A - 90 mg IV dose every 4 weeks at Week 9 and Week 13 Treatment Group B - 90 mg IV dose every 4 weeks at Day 1 and Week 5 | Drug | Treatment Group A, Treatment Group B |
Primary outcome
Total duration (in hours, minutes and seconds) for investigational product preparation and administration
Time frame: Day 1
Total duration (in hours, minutes and seconds) for investigational product preparation and administration
Time frame: Week 5
Total duration (in hours, minutes and seconds) for investigational product preparation and administration
Time frame: Week 9
Total duration (in hours, minutes and seconds) for investigational product preparation and administration
Time frame: Week 13
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing denosumab and pamidronate in people with Solid Tumor and Metastatic Bone Disease, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total duration (in hours, minutes and seconds) for investigational product preparation and administration (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2015.