Metastatic Breast CancerPhase 1NCT01334099
Safety Study of Radiation and CP-675,206 Infusion for Breast Cancer Patients
A Phase 1 study testing CP-675,206 and External local radiation therapy in people with Metastatic Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine the maximum dose of CP-675,206 when given in combination with radiation. Patients will be given local radiation to one tumor site and an intravenous infusion of CP-675,206. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- CP-675,206 and External local radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to Mar 2013
- Phase
- Phase 1
- 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
- Inoperable locally recurrent or metastatic breast cancer
- Performance status 0-1
- Adequate organ function as determined by lab tests
- Greater than 3 weeks since any chemotherapy treatment
- Greater than 2 weeks since last dose of hormonal therapy
Who cannot join
- Previous treatment with any anti-CTLA4 agent
- Patients with active diarrhea
- Patients who will receive radiation to pelvic lesions
- History of chronic inflammatory or autoimmune disorder
- History of insulin-dependent diabetes
- History in the last 5 years of any chronic gastrointestinal conditions
Show all 10Show fewer
- History within the last year of congestive heart failure, stroke, myocardial infarction or thromboembolic event
- Patients with known brain metastasis
- Concurrent treatment with immunosuppressive medication for longer than 10 days within 4 weeks of enrollment or while on trial
- Patients of reproductive potential not using effective contraception, breast-feeding, or patients who test positive for pregnancy at enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Local Radiation and CP-675,206 Administration in Patients With Inoperable Locally Recurrent or Metastatic Breast Cancer
The purpose of this study is to determine the maximum dose of CP-675,206 when given in combination with radiation. Patients will be given local radiation to one tumor site and an intravenous infusion of CP-675,206.
Read the detailed description
Breast cancer is the most common cancer in Canadian women. In 2007 an estimated 22,300 women will be diagnosed and 5300 will die of the disease. Despite advances in therapy, metastatic disease remains an incurable illness, with a median survival of only 2 years. Standard systemic treatment options for metastatic disease include chemotherapy or hormonal therapy. Radiation is frequently used in the metastatic setting for palliation of symptoms, with the most frequent site of radiation being bone. Response rates to first line chemotherapy are in the range of 30%, however these responses are not durable. Currently there are no curative options for metastatic disease, underscoring the need for novel therapeutic approaches.
CTLA4 is a receptor expressed on the surface of activated T cells and regulatory T cells. CTLA-blockade has been tested in clinical trials using humanized monoclonal antibodies, and some biological responses have been reported. The anti-tumor immune response may be further augmented by the combination of CTLA4-blockade with radiation, with the potential to mediate regression of metastases outside of the field of radiation. The primary goal of this study therefore is to establish the safety of CTLA4-blockade using the antibody CP-675, 206 in combination with radiation. This trial is being conducted as a prelude to a planned phase II trial of CP-675,206 in combination with radiation in metastatic breast cancer.
- Conditions
- Metastatic Breast Cancer
- Being tested
- CP-675,206, External local radiation therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-675,206Biological
Intravenous infusion for one cycle (further cycles permitted as per medical assessment). Patient assigned dose of 3mg/kg, 6mg/kg, 10mg/kg, or 15mg/kg.
External local radiation therapyRadiation
One cycle of 2000cGy administered locally to one site over 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Radiation combined with CP-675,206 | Experimental | Not described Receives: Biological: CP-675,206; Radiation: External local radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing safety through toxicities observed using CTCAE version 3.0
Measured: At each study visit for the duration of the 12-week cycle
Secondary outcomes (2)
Evaluating lesions using Response Evaluation Criteria in Solid Tumors (RECIST 1.0)
Measured: Every 8 weeks after treatment
Immunological responses to the treatment measured through analysis of blood draws
Measured: At the end of the 12-week cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startJul 2010
- Primary completionMar 2013
Why it stopped: Contract with drug supplier expired and was not renewed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Srikala Sridhar, MD FRCPC, Principal investigator, University Health Network - Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334099
- Sponsor's protocol ID
- GA3671RD IIR#1
- Status last verified
- Jun 2015
- First submitted
- 18 Jan 2011
- Last updated
- 22 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Local Radiation and CP-675,206 Administration in Patients With Inoperable Locally Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01334099
- Acronym / sponsor ID
- GA3671RD IIR#1
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Contract with drug supplier expired and was not renewed.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Mar 2013 (actual)
- First posted
- 12 Apr 2011 (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.
The purpose of this study is to determine the maximum dose of CP-675,206 when given in combination with radiation. Patients will be given local radiation to one tumor site and an intravenous infusion of CP-675,206.
Detailed description
Breast cancer is the most common cancer in Canadian women. In 2007 an estimated 22,300 women will be diagnosed and 5300 will die of the disease. Despite advances in therapy, metastatic disease remains an incurable illness, with a median survival of only 2 years. Standard systemic treatment options for metastatic disease include chemotherapy or hormonal therapy. Radiation is frequently used in the metastatic setting for palliation of symptoms, with the most frequent site of radiation being bone. Response rates to first line chemotherapy are in the range of 30%, however these responses are not durable. Currently there are no curative options for metastatic disease, underscoring the need for novel therapeutic approaches.
CTLA4 is a receptor expressed on the surface of activated T cells and regulatory T cells. CTLA-blockade has been tested in clinical trials using humanized monoclonal antibodies, and some biological responses have been reported. The anti-tumor immune response may be further augmented by the combination of CTLA4-blockade with radiation, with the potential to mediate regression of metastases outside of the field of radiation. The primary goal of this study therefore is to establish the safety of CTLA4-blockade using the antibody CP-675, 206 in combination with radiation. This trial is being conducted as a prelude to a planned phase II trial of CP-675,206 in combination with radiation in metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation combined with CP-675,206 | Experimental | Biological: CP-675,206, Radiation: External local radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Inoperable locally recurrent or metastatic breast cancer
- Performance status 0-1
- Adequate organ function as determined by lab tests
- Greater than 3 weeks since any chemotherapy treatment
- Greater than 2 weeks since last dose of hormonal therapy
Key exclusion criteria (10 listed)
- Previous treatment with any anti-CTLA4 agent
- Patients with active diarrhea
- Patients who will receive radiation to pelvic lesions
- History of chronic inflammatory or autoimmune disorder
- History of insulin-dependent diabetes
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 |
|---|---|---|
| CP-675,206Intravenous infusion for one cycle (further cycles permitted as per medical assessment). Patient assigned dose of 3mg/kg, 6mg/kg, 10mg/kg, or 15mg/kg. | Biological | Radiation combined with CP-675,206 |
| External local radiation therapyOne cycle of 2000cGy administered locally to one site over 5 days. | Radiation | Radiation combined with CP-675,206 |
Primary outcome
Assessing safety through toxicities observed using CTCAE version 3.0
Time frame: At each study visit for the duration of the 12-week cycle
2 secondary outcomes
Evaluating lesions using Response Evaluation Criteria in Solid Tumors (RECIST 1.0)
Time frame: Every 8 weeks after treatment
Immunological responses to the treatment measured through analysis of blood draws
Time frame: At the end of the 12-week cycle
Results and safety
The study was stopped early (reason given: Contract with drug supplier expired and was not renewed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2015.
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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.
Srikala Sridhar, MD FRCPC principal investigator
University Health Network - Princess Margaret Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CP-675,206 and External local radiation therapy in people with Metastatic Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 5 inclusion and 10 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 22 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 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.
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 (reason given: Contract with drug supplier expired and was not renewed.). 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?
Assessing safety through toxicities observed using CTCAE version 3.0 (time frame: At each study visit for the duration of the 12-week cycle). 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 22 Jun 2015.