Prostate CancerPhase 1/2NCT00757757
A Phase I/II Open-label Study of MCS110 in Patients With Prostate Cancer and Bone Metastases
A Phase 1/2 study testing MCS110 in people with Prostate Cancer and Bone Metastases, run by Novartis Pharmaceuticals at 2 sites in United States.
Trial summary
This study will evaluate the safety and efficacy of MCS110 in patients with prostate cancer and bone metastases Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Bone Metastases
- What is being tested?
- MCS110
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2008to Aug 2009
- Phase
- Phase 1/2
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with asymptomatic castrate-resistant prostate cancer with bone metastases who have not received any bisphosphonates in the 12 months prior to enrollment
- 18 years old and over
Who cannot join
- Plan to be on cytotoxic or biologic therapy during study
- Active dental problems
- Active heart complications
- Active infection
- Patients with moderate to severe swelling due to fluid
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NV Cancer Institute
Las Vegas, Nevada, 89135
CTRC
San Antonio, Texas, 78229
About this study
Official title: A Phase I/II Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MCS110 in Patients With Prostate Cancer and Bone Metastases
This study will evaluate the safety and efficacy of MCS110 in patients with prostate cancer and bone metastases
- Conditions
- Prostate Cancer, Bone Metastases
- Being tested
- MCS110
- Keywords
- Prostate cancer, bone metastases, anti-M-CSF, M-CSF antibody, M-CSF, Prostate Cancer with bone metastases
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCS110Drug
Anti-M-CSF antibody
| Study group | Role | What they receive |
|---|---|---|
| MCS110 | Experimental | Not described Receives: Drug: MCS110 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and characteristics of treatment related dose-limiting-toxicities in dose escalation phase
Measured: every cycle - (cycle = 28 days)
Type and frequency of adverse drug reactions and serious adverse drug reactions
Measured: every cycle - (cycle = 28 days)
Secondary outcomes (1)
Change in markers of bone resorption and formation (pre- vs. post-treatment)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757757
- Sponsor's protocol ID
- CMCS110A2101
- Status last verified
- Aug 2020
- First submitted
- 21 Sep 2008
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MCS110 in Patients With Prostate Cancer and Bone Metastases
- ClinicalTrials.gov ID
- NCT00757757
- Acronym / sponsor ID
- CMCS110A2101
- Conditions
- Prostate Cancer, Bone Metastases
- Keywords
- Prostate cancer, bone metastases, anti-M-CSF, M-CSF antibody, M-CSF, Prostate Cancer with bone metastases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 23 Sep 2008 (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 evaluate the safety and efficacy of MCS110 in patients with prostate cancer and bone metastases
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MCS110 | Experimental | Drug: MCS110 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with asymptomatic castrate-resistant prostate cancer with bone metastases who have not received any bisphosphonates in the 12 months prior to enrollment
- 18 years old and over
Key exclusion criteria (6 listed)
- Plan to be on cytotoxic or biologic therapy during study
- Active dental problems
- Active heart complications
- Active infection
- Patients with moderate to severe swelling due to fluid
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 |
|---|---|---|
| MCS110Anti-M-CSF antibody | Drug | MCS110 |
Primary outcome
Frequency and characteristics of treatment related dose-limiting-toxicities in dose escalation phase
Time frame: every cycle - (cycle = 28 days)
Type and frequency of adverse drug reactions and serious adverse drug reactions
Time frame: every cycle - (cycle = 28 days)
1 secondary outcome
Change in markers of bone resorption and formation (pre- vs. post-treatment)
Time frame: 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Results for CMCS110A2101 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MCS110 in people with Prostate Cancer and Bone Metastases, run by Novartis Pharmaceuticals at 2 sites in United States.
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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 stopped early. Results are not available in the source record.
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?
Frequency and characteristics of treatment related dose-limiting-toxicities in dose escalation phase (time frame: every cycle - (cycle = 28 days)). The study lists 2 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 19 Dec 2020.