Colorectal NeoplasmsPhase 2NCT00313794
Study of Ticilimumab in Patients With Metastatic Colorectal Cancer Whose Disease Had Progressed After Treatment
A Phase 2 study testing CP-675,206 in people with Colorectal Neoplasms, run by AstraZeneca at 11 sites in 2 countries.
Trial summary
This study is for patients with metastatic adenocarcinoma arising from the colon or rectum who have received treatment(s) for metastatic disease with subsequent disease progression. Patients who are intolerant to treatment(s) are also included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- CP-675,206
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 11 sitesin 2 countries
- Study dates
- May 2006to Jun 2008
- Phase
- Phase 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiographic evidence of metastatic, progressive disease following standard therapies.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Who cannot join
- Known brain metastases or uncontrolled pleural effusions.
- History of chronic inflammatory or autoimmune disease.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States9 sites
Research Site
Bessemer, Alabama, 35022
Research Site
Birmingham, Alabama, 35205
Research Site
Birmingham, Alabama, 35209
Research Site
Birmingham, Alabama, 35211
Research Site
Birmingham, Alabama, 35213
Research Site
Birmingham, Alabama, 35235
Research Site
New York, New York, 10022
Research Site
San Francisco, California, 94115
Research Site
San Francisco, California, 94143
Canada2 sites
Research Site
Lévis, Quebec, G6V 3Z1
Research Site
Québec, Quebec, G1R 2J6
About this study
Official title: Phase 2, Single Arm Study Of Ticilimumab In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum
This study is for patients with metastatic adenocarcinoma arising from the colon or rectum who have received treatment(s) for metastatic disease with subsequent disease progression. Patients who are intolerant to treatment(s) are also included. This is a study for good performance status colorectal cancer patients who have exhausted standard therapy options.
- Conditions
- Colorectal Neoplasms
- Being tested
- CP-675,206
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-675,206Drug
Also called ticilimumab, tremelimumab
15 mg/kg IV q 3 months for 4 cycles in the absence of disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | single arm Receives: Drug: CP-675,206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the best overall response rate per RECIST (BRR) in patients with metastatic adenocarcinoma of the colon or rectum treated with CP-675,206 .
Measured: 18 months
Secondary outcomes (5)
To evaluate the safety and tolerability of CP-675,206 in this population.
Measured: 18 mos
To identify any human anti human antibody (HAHA) response to CP-675,206 .
Measured: 3 yrs
To identify potential relationships between polymorphisms in the Cytotoxic T lymphocyte-associated antigen 4 (CTLA4), Fcgamma receptor IIa (FcgRIIa), IgG2a genes with safety and/or immune response of patients treated with CP-675,206.
Measured: 3 yrs
To assess additional evidence of anti-tumor activity as measured by duration of response, progression-free survival and overall survival.
Measured: 2 yrs
To obtain pharmacokinetic (PK) data to be evaluated in a future meta analysis of CP-675,206 pharmacokinetics.
Measured: 3 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startMay 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313794
- Sponsor's protocol ID
- A3671014
- Status last verified
- Jun 2012
- First submitted
- 10 Apr 2006
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Single Arm Study Of Ticilimumab In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum
- ClinicalTrials.gov ID
- NCT00313794
- Acronym / sponsor ID
- A3671014
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 12 Apr 2006 (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 is for patients with metastatic adenocarcinoma arising from the colon or rectum who have received treatment(s) for metastatic disease with subsequent disease progression. Patients who are intolerant to treatment(s) are also included. This is a study for good performance status colorectal cancer patients who have exhausted standard therapy options.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CP-675,206single arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Radiographic evidence of metastatic, progressive disease following standard therapies.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Key exclusion criteria (2 listed)
- Known brain metastases or uncontrolled pleural effusions.
- History of chronic inflammatory or autoimmune disease.
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-675,206Also: ticilimumab, tremelimumab15 mg/kg IV q 3 months for 4 cycles in the absence of disease progression or unacceptable toxicity. | Drug | 1 |
Primary outcome
To assess the best overall response rate per RECIST (BRR) in patients with metastatic adenocarcinoma of the colon or rectum treated with CP-675,206 .
Time frame: 18 months
5 secondary outcomes
To evaluate the safety and tolerability of CP-675,206 in this population.
Time frame: 18 mos
To identify any human anti human antibody (HAHA) response to CP-675,206 .
Time frame: 3 yrs
To identify potential relationships between polymorphisms in the Cytotoxic T lymphocyte-associated antigen 4 (CTLA4), Fcgamma receptor IIa (FcgRIIa), IgG2a genes with safety and/or immune response of patients treated with CP-675,206.
Time frame: 3 yrs
To assess additional evidence of anti-tumor activity as measured by duration of response, progression-free survival and overall survival.
Time frame: 2 yrs
To obtain pharmacokinetic (PK) data to be evaluated in a future meta analysis of CP-675,206 pharmacokinetics.
Time frame: 3 yrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP-675,206 in people with Colorectal Neoplasms, run by AstraZeneca at 11 sites in 2 countries.
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 2 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: finished, as of the sponsor's last update on 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the best overall response rate per RECIST (BRR) in patients with metastatic adenocarcinoma of the colon or rectum treated with CP-675,206 . (time frame: 18 months). 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 7 Jun 2012.