Sarcoma, Ewing'sPhase 1NCT00474760
Study Of Anti-IGF-IR CP-751,871 In Patients With Solid Tumors
A Phase 1 study testing CP-751,871 in people with Sarcoma, Ewing's, run by Pfizer at 3 sites in 2 countries.
Trial summary
This is a phase 1 study of anti-IGF-IR CP-751,871 in patients with solid tumors currently enrolling patients 9 years old and older with Ewing's sarcoma family of tumors (Ewing's, PNET and Askin's). Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Sarcoma, Ewing's
- 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
- 65 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2005to Oct 2012
- Phase
- Phase 1
- 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 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Ewing's sarcoma family tumors
Who cannot join
- Concurrent treatment with any other anti tumor agents
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48109-0848
Pfizer Investigational Site
Rochester, Minnesota, 55905
United Kingdom1 site
Pfizer Investigational Site
Sutton, Surrey, SM2 5PT
About this study
Official title: Phase 1, Open Label, Multiple Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of CP 751,871 In Patients With Advanced Solid Tumors
This is a phase 1 study of anti-IGF-IR CP-751,871 in patients with solid tumors currently enrolling patients 9 years old and older with Ewing's sarcoma family of tumors (Ewing's, PNET and Askin's).
- Conditions
- Sarcoma, Ewing's
- Being tested
- CP-751,871
- Medical subject headings
- Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-751,871Drug
Currently dosing at 20 mg/kg, IV on day 1 of each 28 day cycle until progression or unacceptable 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.
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 150 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Measured: Baseline up to 150 days after the last administration of study drug
Secondary outcomes (26)
Maximum Observed Plasma Concentration (Cmax) in Cycle 1
Measured: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Maximum Observed Plasma Concentration (Cmax) in Cycle 4
Measured: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1
Measured: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4
Measured: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Plasma Decay Half-Life (t1/2) in Cycle 1
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Plasma Decay Half-Life (t1/2) in Cycle 4
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 1
Measured: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 4
Measured: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Systemic Clearance (CL) in Cycle 1
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Systemic Clearance (CL) in Cycle 4
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Concentration at End of Infusion (Cendinf) in Cycle 1
Measured: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Concentration at End of Infusion (Cendinf) in Cycle 4
Measured: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Volume of Distribution (Vz) in Cycle 1
Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Measured: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Volume of Distribution (Vz) in Cycle 4
Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Measured: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Volume of Distribution at Steady State (Vss) in Cycle 1
Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state.
Measured: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Volume of Distribution at Steady State (Vss) in Cycle 4
Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state.
Measured: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 1
Area under the plasma concentration time-curve from zero to the last measured concentration
Measured: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 4
Area under the plasma concentration time-curve from zero to the last measured concentration
Measured: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] in Cycle 1
Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
Measured: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 1
Measured: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 4
Measured: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 1
Measured: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 4
Measured: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Human Anti-human Antibodies (HAHA) Levels
HAHA were indicators of immunogenicity to figitumumab.
Measured: 30 minutes predose in Cycles 1 up to 61, and last scheduled follow-up visit (up to 150 days from the last dose of study drug)
Number of Circulating Tumor Cells (CTCs)
Quantification of CTCs using an automated microscope system
Measured: 30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort
Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs
Quantification of IGF-IR positive CTCs using an automated microscope system
Measured: 30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2007 (estimated)
- Study startAug 2005
- Primary completionJan 2011
- 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 (2)Papers the sponsor has linked to this study.
- Other trials for Sarcoma, Ewing'sStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 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
- NCT00474760
- Sponsor's protocol ID
- A4021010
- Status last verified
- Oct 2013
- First submitted
- 16 May 2007
- Last updated
- 17 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchere D, Kurtz JE, Bergerat JP, Blay JY. Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: a predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas. Eur J Cancer. 2012 Nov;48(16):3027-35. doi: 10.1016/j.ejca.2012.05.009. Epub 2012 Jun 7.
PubMed 22682017Olmos D, Postel-Vinay S, Molife LR, Okuno SH, Schuetze SM, Paccagnella ML, Batzel GN, Yin D, Pritchard-Jones K, Judson I, Worden FP, Gualberto A, Scurr M, de Bono JS, Haluska P. Safety, pharmacokinetics, and preliminary activity of the anti-IGF-1R antibody figitumumab (CP-751,871) in patients with sarcoma and Ewing's sarcoma: a phase 1 expansion cohort study. Lancet Oncol. 2010 Feb;11(2):129-35. doi: 10.1016/S1470-2045(09)70354-7. Epub 2009 Dec 23.
PubMed 20036194
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open Label, Multiple Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of CP 751,871 In Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00474760
- Acronym / sponsor ID
- A4021010
- Conditions
- Sarcoma, Ewing's
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Jan 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 17 May 2007 (estimated)
- Results
- Posted 17 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1 study of anti-IGF-IR CP-751,871 in patients with solid tumors currently enrolling patients 9 years old and older with Ewing's sarcoma family of tumors (Ewing's, PNET and Askin's).
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
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Ewing's sarcoma family tumors
Key exclusion criteria (1 listed)
- Concurrent treatment with any other anti tumor 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-751,871Currently dosing at 20 mg/kg, IV on day 1 of each 28 day cycle until progression or unacceptable toxicity | Drug | 1 |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 150 days after the last administration of study drug
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 150 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
26 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) in Cycle 1
Time frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Maximum Observed Plasma Concentration (Cmax) in Cycle 4
Time frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1
Time frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4
Time frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Plasma Decay Half-Life (t1/2) in Cycle 1
Time frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Plasma Decay Half-Life (t1/2) in Cycle 4
Time frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 1
Time frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 4
Time frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Systemic Clearance (CL) in Cycle 1
Time frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Systemic Clearance (CL) in Cycle 4
Time frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Concentration at End of Infusion (Cendinf) in Cycle 1
Time frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Concentration at End of Infusion (Cendinf) in Cycle 4
Time frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Volume of Distribution (Vz) in Cycle 1
Time frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Volume of Distribution (Vz) in Cycle 4
Time frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Volume of Distribution at Steady State (Vss) in Cycle 1
Time frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Volume of Distribution at Steady State (Vss) in Cycle 4
Time frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 1
Time frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 4
Time frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] in Cycle 1
Time frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 1
Time frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 4
Time frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 1
Time frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 4
Time frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Human Anti-human Antibodies (HAHA) Levels
Time frame: 30 minutes predose in Cycles 1 up to 61, and last scheduled follow-up visit (up to 150 days from the last dose of study drug)
Number of Circulating Tumor Cells (CTCs)
Time frame: 30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort
Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs
Time frame: 30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22682017Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchere D, Kurtz JE, Bergerat JP, Blay JY. Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: a predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas. Eur J Cancer. 2012 Nov;48(16):3027-35. doi: 10.1016/j.ejca.2012.05.009. Epub 2012 Jun 7.
- Derived from this study: PubMed 20036194Olmos D, Postel-Vinay S, Molife LR, Okuno SH, Schuetze SM, Paccagnella ML, Batzel GN, Yin D, Pritchard-Jones K, Judson I, Worden FP, Gualberto A, Scurr M, de Bono JS, Haluska P. Safety, pharmacokinetics, and preliminary activity of the anti-IGF-1R antibody figitumumab (CP-751,871) in patients with sarcoma and Ewing's sarcoma: a phase 1 expansion cohort study. Lancet Oncol. 2010 Feb;11(2):129-35. doi: 10.1016/S1470-2045(09)70354-7. Epub 2009 Dec 23.
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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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CP-751,871 in people with Sarcoma, Ewing's, run by Pfizer at 3 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 1 inclusion and 1 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 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 17 Dec 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?
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to 150 days after the last administration of study drug). 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 NCT00474760, which also lists 2 linked publications.
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 17 Dec 2013.