Ewing's Sarcoma Family of TumorsPhase 1/2NCT00560235
Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors
A Phase 1/2 study testing CP-751,871 in people with Ewing's Sarcoma Family of Tumors, run by Pfizer at 37 sites in 11 countries.
Trial summary
Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Ewing's Sarcoma Family of Tumors
- What is being tested?
- CP-751,871
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 37 sitesin 11 countries
- Study dates
- Mar 2008to Oct 2012
- Phase
- Phase 1/2
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ewing's family of tumors
- Current disease state for which there is no curative therapy
Who cannot join
- Prior anti-IGF-1R therapy
- Concurrent treatment with other anti-cancer agents
Trial locations and contacts
37 sites in 11 countries.
37 sites in 11 countries
United States10 sites
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Dallas, Texas, 75235
Pfizer Investigational Site
Memphis, Tennessee, 38105
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
New York, New York, 10065
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104-4399
Pfizer Investigational Site
Providence, Rhode Island, 02903
Pfizer Investigational Site
Rochester, Minnesota, 55905
Pfizer Investigational Site
Seattle, Washington, 98105
Pfizer Investigational Site
Tampa, Florida, 33612-9497
United Kingdom5 sites
Pfizer Investigational Site
London, NW1 2PG
Pfizer Investigational Site
London, SW3 6JJ
Pfizer Investigational Site
Oxford, OX3 7LJ
Pfizer Investigational Site
Oxford, OX3 9DU
Pfizer Investigational Site
Sutton, Surrey, SM2 5PT
France4 sites
Pfizer Investigational Site
Lille, 59020
Pfizer Investigational Site
Lyon, 69373
Pfizer Investigational Site
Paris, 75005
Pfizer Investigational Site
Villejuif, 94805
Germany4 sites
Pfizer Investigational Site
Berlin, 13353
Pfizer Investigational Site
Freiburg im Breisgau, 79106
Pfizer Investigational Site
München, 80804
Pfizer Investigational Site
Münster, 48149
Spain4 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08035
Pfizer Investigational Site
Esplugues de Llobregat, Barcelona, 08950
Pfizer Investigational Site
Madrid, Madrid, 28046
Pfizer Investigational Site
Valencia, Valencia, 46026
Italy3 sites
Pfizer Investigational Site
Bologna, 40136
Pfizer Investigational Site
Milan, 20133
Pfizer Investigational Site
Torino, 10126
Australia2 sites
Pfizer Investigational Site
Brisbane, Queensland, 4029
Pfizer Investigational Site
Parkville, Victoria, 3052
Israel2 sites
Pfizer Investigational Site
Jerusalem, 91120
Pfizer Investigational Site
Petah Tikva, 49202
About this study
Official title: A Phase 1/Phase 2 Study Of CP-751,871 In Patients With Relapsed And/Or Refractory Ewing's Sarcoma Family Of Tumors
Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors
- Conditions
- Ewing's Sarcoma Family of Tumors
- Being tested
- CP-751,871
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-751,871Drug
Final dose 30 mg/kg IV on Day 1 of each 28 day cycle until either progression or toxicity
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: CP-751,871 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or 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 and no new lesions. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions.
Measured: Baseline and every cycle (4 weeks), for up to 6 cycles
Secondary outcomes (8)
Progression-Free Survival (PFS)
PFS was the time in months from start date to date of first documentation of progression, death due to any cause or symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment).
Measured: Baseline and every cycle (4 weeks), until progression or death
Overall Survival (OS)
Time in months from enrollment to death. For participants who are alive, overall survival was censored at the last contact.
Measured: Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment
Maximum Observed Plasma Concentration (Cmax)
Measured: Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1
Minimum Observed Plasma Trough Concentration (Cmin)
Cmin is the concentration at the end of treatment cycle (next cycle predose).
Measured: Cycle 6: predose on Day 1
Plasma Concentration at End of Infusion (Cendinf)
Measured: Cycle 1 Day 2 and Cycle 5 Day 1
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
The dosing interval was 1 cycle (4 weeks) in this study.
Measured: Cycle 5: 1 hour post-infusion on Day 1
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.
Measured: Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1
Number of Participants With Positive Anti-Drug Antibody (ADA) Titer
Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer <6.64 corresponded to negative ADA category value.
Measured: Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose)
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 startMar 2008
- Primary completionMar 2010
- Study completionOct 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ewing's Sarcoma Family of TumorsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 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
- NCT00560235
- Sponsor's protocol ID
- A4021020
- Status last verified
- Oct 2015
- First submitted
- 15 Nov 2007
- Last updated
- 28 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Juergens H, Daw NC, Geoerger B, Ferrari S, Villarroel M, Aerts I, Whelan J, Dirksen U, Hixon ML, Yin D, Wang T, Green S, Paccagnella L, Gualberto A. Preliminary efficacy of the anti-insulin-like growth factor type 1 receptor antibody figitumumab in patients with refractory Ewing sarcoma. J Clin Oncol. 2011 Dec 1;29(34):4534-40. doi: 10.1200/JCO.2010.33.0670. Epub 2011 Oct 24.
PubMed 22025154
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/Phase 2 Study Of CP-751,871 In Patients With Relapsed And/Or Refractory Ewing's Sarcoma Family Of Tumors
- ClinicalTrials.gov ID
- NCT00560235
- Acronym / sponsor ID
- A4021020
- Conditions
- Ewing's Sarcoma Family of Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 19 Nov 2007 (estimated)
- Results
- Posted 28 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors
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-751,871 |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Ewing's family of tumors
- Current disease state for which there is no curative therapy
Key exclusion criteria (2 listed)
- Prior anti-IGF-1R therapy
- Concurrent treatment with other anti-cancer agents
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-751,871Final dose 30 mg/kg IV on Day 1 of each 28 day cycle until either progression or toxicity | Drug | 1 |
Primary outcome
Objective Response Rate (ORR)
Time frame: Baseline and every cycle (4 weeks), for up to 6 cycles
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or 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 and no new lesions. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions.
8 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Baseline and every cycle (4 weeks), until progression or death
Overall Survival (OS)
Time frame: Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment
Maximum Observed Plasma Concentration (Cmax)
Time frame: Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1
Minimum Observed Plasma Trough Concentration (Cmin)
Time frame: Cycle 6: predose on Day 1
Plasma Concentration at End of Infusion (Cendinf)
Time frame: Cycle 1 Day 2 and Cycle 5 Day 1
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Time frame: Cycle 5: 1 hour post-infusion on Day 1
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1
Number of Participants With Positive Anti-Drug Antibody (ADA) Titer
Time frame: Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22025154Juergens H, Daw NC, Geoerger B, Ferrari S, Villarroel M, Aerts I, Whelan J, Dirksen U, Hixon ML, Yin D, Wang T, Green S, Paccagnella L, Gualberto A. Preliminary efficacy of the anti-insulin-like growth factor type 1 receptor antibody figitumumab in patients with refractory Ewing sarcoma. J Clin Oncol. 2011 Dec 1;29(34):4534-40. doi: 10.1200/JCO.2010.33.0670. Epub 2011 Oct 24.
- 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
37 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CP-751,871 in people with Ewing's Sarcoma Family of Tumors, run by Pfizer at 37 sites in 11 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 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, United Kingdom, France, Germany, Spain and 6 more countries. 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?
Yes. Results are posted in the registry (first posted 28 Feb 2014). 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?
Objective Response Rate (ORR) (time frame: Baseline and every cycle (4 weeks), for up to 6 cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00560235, which also lists 1 linked publication.
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 28 Oct 2015.