Colorectal NeoplasmPhase 2NCT00560560
Study Using CP-751,871 In Patients With Stage IV Colorectal Cancer That Has Not Responded To Previous Anti-Cancer Treatments
A Phase 2 study testing CP-751, 871 in people with Colorectal Neoplasm, run by Pfizer at 12 sites in 3 countries.
Trial summary
This study will test if there is any survival benefit in patients with refractory metastatic colorectal cancer that receive CP-751, 871. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasm
- What is being tested?
- CP-751, 871
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Dec 2007to Sep 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients who have stage IV colorectal cancer
- Patients whose disease has worsened despite prior anti-cancer therapy
- Patients who have satisfactory bonemarrow, kidney and liver function
Who cannot join
- Patients who are being simultaneously treated with another anti-cancer therapy.
- Patients who have previously received anti-cancer therapy that works like CP-751, 871 (targets insulin-like growth factor receptor)
- Patients that are pregnant or breast-feeding
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United Kingdom6 sites
Pfizer Investigational Site
Cardiff, CF14 2TL
Pfizer Investigational Site
Glasgow, G12 0YN
Pfizer Investigational Site
Leicester, Leicestershire, LE1 5WW
Pfizer Investigational Site
Peterborough, Cambridgeshire, PE3 6DA
Pfizer Investigational Site
Peterborough, PE3 6DA
Pfizer Investigational Site
Southampton, SO16 6YD
Spain4 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08003
Pfizer Investigational Site
Elche, Alicante, 03202
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08907
Pfizer Investigational Site
Seville, Sevilla, 41013
United States2 sites
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
San Francisco, California, 94115
About this study
Official title: A Phase II, Single Arm Study Of CP-751,871 In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum
This study will test if there is any survival benefit in patients with refractory metastatic colorectal cancer that receive CP-751, 871.
- Conditions
- Colorectal Neoplasm
- Being tested
- CP-751, 871
- Keywords
- Refractory Colorectal, Single arm, Phase 2
- 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-751, 871Biological
Human IgG2 Monoclonal Antibody. 20mg/kg or 30 mg/kg every 3 weeks for 17 cycles, until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Single arm study Receives: Biological: CP-751, 871 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate of the 6 Month Survival Probability
The 6 month survival probability was defined as the probability of survival at 6 months based on the Kaplan-Meier estimate. The time was from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.
Measured: Baseline up to Month 6
Secondary outcomes (7)
Overall Survival
The time from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.
Measured: From date of enrollment until death or censorship, up to 33 months
Progression-Free Survival (PFS)
The period from study entry until disease progression. Participants without progression or death were censored at time of last disease assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 20% increase in the sum of longest diameters of target measurable lesions, or a clear increase in a non-target lesion, or the apprearance of new lesions.
Measured: Baseline until tumor progression or censorship, up to 33 months. The frequency of tumor assessments was screening, every cycle, end of treatment (within 28 days of last dose of study drug), and follow-up.
Percentage of Participants With Objective Response
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease. PR applied only to participants with at least one measurable lesion. Greater than or equal to 30 % decrease under baseline of the sum of longest diameters of all target measurable lesions.
Measured: Baseline, every cycle (Day 15-21 or according to local standard), end of treatment (within 28 days of last dose of study drug) and follow-up (150 days after last dose of study drug), up to 33 months
Descriptive Summary of Figitumumab Concentration Versus Time
The measurement of mean plasma concentration of figitumumab in Day 1 of Cycle 1,2,3,4,5
Measured: Pre-dose on Day 1, 1 hour after end of infusion (post-dose) on Day 2 in Cycle 1, pre-dose on Day 1 in Cycles 2,3,4, 1 hour post-dose on Day 1 in Cycle 5
Participants Reporting Positive for Total Anti-drug Antibodies (ADA)
The immunogenicity of figitumumab in terms of producing an antidrug antibody (ADA) response were monitored.
Measured: Up to 2 hours prior to infusion in Cycles 1 and 4, at the end of treatment, and at the 4th scheduled follow-up visit (~150 days after the last infusion)
Counts of Circulating Tumor Cells (CTCs) Expressing Positive Insulin-like Growth Factor 1 Receptor (IGF-1R)
The quantification of circulating tumor cells (CTCs) expressing the IGF-1R in this patient population. Blood samples were collected, and were measured using an automated microscope system.
Measured: Cycle 1 pre-dosing and Cycle 4 pre-dosing
Counts of Circulating Tumor Cells (CTCs)
The quantification of circulating tumor cells (CTCs)in this patient population. Blood samples were collected, and were measured using an automated microscope system.
Measured: Cycle 1 pre-dosing and Cycle 4 pre-dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal NeoplasmStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560560
- Sponsor's protocol ID
- A4021006
- Status last verified
- May 2013
- First submitted
- 15 Nov 2007
- Last updated
- 20 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single Arm Study Of CP-751,871 In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum
- ClinicalTrials.gov ID
- NCT00560560
- Acronym / sponsor ID
- A4021006
- Conditions
- Colorectal Neoplasm
- Keywords
- Refractory Colorectal, Single arm, Phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 19 Nov 2007 (estimated)
- Results
- Posted 9 May 2013
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 test if there is any survival benefit in patients with refractory metastatic colorectal cancer that receive CP-751, 871.
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 | Biological: CP-751, 871Single arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have stage IV colorectal cancer
- Patients whose disease has worsened despite prior anti-cancer therapy
- Patients who have satisfactory bonemarrow, kidney and liver function
Key exclusion criteria (3 listed)
- Patients who are being simultaneously treated with another anti-cancer therapy.
- Patients who have previously received anti-cancer therapy that works like CP-751, 871 (targets insulin-like growth factor receptor)
- Patients that are pregnant or breast-feeding
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-751, 871Human IgG2 Monoclonal Antibody. 20mg/kg or 30 mg/kg every 3 weeks for 17 cycles, until progression or unacceptable toxicity develops. | Biological | 1 |
Primary outcome
Estimate of the 6 Month Survival Probability
Time frame: Baseline up to Month 6
The 6 month survival probability was defined as the probability of survival at 6 months based on the Kaplan-Meier estimate. The time was from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.
7 secondary outcomes
Overall Survival
Time frame: From date of enrollment until death or censorship, up to 33 months
Progression-Free Survival (PFS)
Time frame: Baseline until tumor progression or censorship, up to 33 months. The frequency of tumor assessments was screening, every cycle, end of treatment (within 28 days of last dose of study drug), and follow-up.
Percentage of Participants With Objective Response
Time frame: Baseline, every cycle (Day 15-21 or according to local standard), end of treatment (within 28 days of last dose of study drug) and follow-up (150 days after last dose of study drug), up to 33 months
Descriptive Summary of Figitumumab Concentration Versus Time
Time frame: Pre-dose on Day 1, 1 hour after end of infusion (post-dose) on Day 2 in Cycle 1, pre-dose on Day 1 in Cycles 2,3,4, 1 hour post-dose on Day 1 in Cycle 5
Participants Reporting Positive for Total Anti-drug Antibodies (ADA)
Time frame: Up to 2 hours prior to infusion in Cycles 1 and 4, at the end of treatment, and at the 4th scheduled follow-up visit (~150 days after the last infusion)
Counts of Circulating Tumor Cells (CTCs) Expressing Positive Insulin-like Growth Factor 1 Receptor (IGF-1R)
Time frame: Cycle 1 pre-dosing and Cycle 4 pre-dosing
Counts of Circulating Tumor Cells (CTCs)
Time frame: Cycle 1 pre-dosing and Cycle 4 pre-dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP-751, 871 in people with Colorectal Neoplasm, run by Pfizer at 12 sites in 3 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 3 inclusion and 3 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 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom, Spain, 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 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?
Yes. Results are posted in the registry (first posted 9 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Estimate of the 6 Month Survival Probability (time frame: Baseline up to Month 6). 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 20 May 2013.