Advanced CancerPhase 1NCT00729833

Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors

A Phase 1 study testing CP-751,871 and Sunitinib in people with Advanced Cancer and Advanced Solid Tumors, run by Pfizer at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The study is being conducted to determine the maximum tolerated dose, overall safety and tolerability profile, and pharmacokinetic profile of CP-751,871 and sunitinib when given in combination with advanced solid tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Cancer, Advanced Solid Tumors
What is being tested?: CP-751,871 and Sunitinib
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 4 sitesUnited States
Study dates: Sep 2008to Apr 2013
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically or cytologically confirmed advanced solid tumors relapsed or refractory to standard therapy or for whom no standard therapy exists.
ECOG Performance Status of 0 or 1;
Total IGF-1 level ≥100 ng/ml;
ECOG Performance Status of 0 or 1
Adequate bone marrow, renal, and hepatic function

Who cannot join

Concurrent treatment with any antitumor agents with the exception of LHRH agnosits for prostate cancer patients
Treatment with any other investigational therapy within 4 weeks prior to study treatment
Major surgery within 4 weeks of study treatment
Prior treatment that may increase the risk of cardiac complications
Ongoing cardiac dysrhythmias of NCI CTCAE Grade 2 or greater
Significant active cardiac disease, including hypertension that cannot be controlled by medications

Show all 9Show fewer

Greater than three (3) prior lines of cytotoxic therapy;
Active infection
Prior IGF-IR targeted therapy;

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Pfizer Investigational Site
Los Angeles, California, 90095
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Santa Monica, California, 90404

Other trials in United States

About this study

Official title: Phase 1, Open Label, Sequential Cohort, Dose Escalation Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors

Read the detailed description

The study was closed to enrollment on 14 Jan 2011 and terminated secondary to excessive screen failure rate and for business reasons associated with Pfizer's business decision to stop development of the figitumumab compound. Safety concerns did not contribute to the decision to terminate this clinical trial.

Conditions: Advanced Cancer, Advanced Solid Tumors
Being tested: CP-751,871, Sunitinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CP-751,871Drug
CP-751,871 IV, every 3 weeks
SunitinibDrug
Sunitinib - daily dosing

Study groups in NCT00729833
Study group	Role	What they receive
CP-751,871 + Sunitinib	Experimental	Escalating cohorts of CP-751,871 + Sunitinib Receives: Drug: CP-751,871; Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Dose-Limiting Toxicities (DLT)
Number of participants with treatment-related Grade 3/4 toxicities that occurred during the defined time frame or that resulted in greater than or equal to (>=) 7 days delay in administration of Cycle 2.
Toxicities were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Measured: Baseline up to the end of Cycle 1 (each cycle=3 weeks)

Secondary outcomes (14)

Percentage of Participants With Treatment-Emergent Adverse Events, by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events Grade Version 3.0
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the worst CTCAE grade was reported. Severity grades were 0 (no change from normal or reference range), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), and 5 (death).
Measured: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)
Percentage of Participants With Hematologic Laboratory Test Abnormality
Percentage of participants with hematologic laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).
Measured: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)
Percentage of Participants With Blood Chemistry Laboratory Test Abnormality
Percentage of participants with blood chemistry laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).
Measured: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)
Plasma Concentration at the End of Infusion (Cendinf) of Figitumumab
Measured: 0.5 hour predose and 1 hour post-infusion on Day 1 of Cycles 1 and 4
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab
AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.
Measured: 0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, 15, and 22 of Cycles 1 and 4
Area Under the Curve From Time Zero to Day 22 [AUC504] of Figitumumab
AUC504 is the area under the plasma concentration versus time curve from time zero (predose) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.
Measured: 0.5 hour predose and 504 hours (Day 22) post-infusion of Cycles 1 and 4
Plasma Decay Half-Life (t1/2) of Figitumumab
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, and 15 of Cycles 1 and 4
Maximum Observed Plasma Concentration (Cmax) of Sunitinib
Measured: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib
Measured: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1
Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of Sunitinib
AUC24 is the area under the plasma concentration versus time curve from time zero (predose) to 24 hours postdose (0 to 24).
Measured: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1
Trough Plasma Concentration (Ctrough) of Sunitinib
Measured: 0.5 hour predose on Day 1 of Cycle 2
Plasma Concentration at 24 Hours Postdose (C24) of Sunitinib
Measured: 24 hours postdose on Day 15 of Cycle 1
Number of Participants With Anti-Drug Antibodies (ADA)
Assays for ADA assessment specific for figitumumab would have provided information regarding an immune response to the compound.
Measured: 0.5 hour pre-infusion on Day 1 in Cycles 1 and 2, at end of treatment, and during the last scheduled follow-up visit (5 months from the last dose of study drug)
Number of Participants With Objective Response (OR)
Objective response (OR) was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. CR was the complete disappearance of all target and non-target disease, no new lesions, or the normalization of markers (if markers were being followed). PR was greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions, no unequivocal progression of non-target disease, no new lesions, or no reappearance of lesions after a CR. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.
Measured: Baseline, Day 15 of every 2 cycles until disease progression up to follow-up (approximately 28 days following the last dose of study drug)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Apr 2013

First posted8 Aug 2008 (estimated)
Study startSep 2008
Primary completionAug 2011
Study completionApr 2013

Why it stopped: See termination reason in detailed description.

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 Advanced CancerStudies 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: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00729833
Sponsor's protocol ID: A4021024
Status last verified: May 2014
First submitted: 30 Jul 2008
Last updated: 9 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1, Open Label, Sequential Cohort, Dose Escalation Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT00729833
Acronym / sponsor ID: A4021024
Conditions: Advanced Cancer, Advanced Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 45 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Aug 2011 (actual)
Study completion: Apr 2013 (actual)
First posted: 8 Aug 2008 (estimated)
Results: Posted 9 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CP-751,871 + Sunitinib	Experimental	Drug: CP-751,871, Drug: SunitinibEscalating cohorts of CP-751,871 + Sunitinib

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Histologically or cytologically confirmed advanced solid tumors relapsed or refractory to standard therapy or for whom no standard therapy exists.
ECOG Performance Status of 0 or 1;
Total IGF-1 level ≥100 ng/ml;
ECOG Performance Status of 0 or 1
Adequate bone marrow, renal, and hepatic function

Key exclusion criteria (9 listed)

Concurrent treatment with any antitumor agents with the exception of LHRH agnosits for prostate cancer patients
Treatment with any other investigational therapy within 4 weeks prior to study treatment
Major surgery within 4 weeks of study treatment
Prior treatment that may increase the risk of cardiac complications
Ongoing cardiac dysrhythmias of NCI CTCAE Grade 2 or greater

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-751,871CP-751,871 IV, every 3 weeks	Drug	CP-751,871 + Sunitinib
SunitinibSunitinib - daily dosing	Drug	CP-751,871 + Sunitinib

Primary outcome

Number of Participants With Dose-Limiting Toxicities (DLT)
Time frame: Baseline up to the end of Cycle 1 (each cycle=3 weeks)
Number of participants with treatment-related Grade 3/4 toxicities that occurred during the defined time frame or that resulted in greater than or equal to (>=) 7 days delay in administration of Cycle 2. Toxicities were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.

14 secondary outcomes

Percentage of Participants With Treatment-Emergent Adverse Events, by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events Grade Version 3.0
Time frame: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)
Percentage of Participants With Hematologic Laboratory Test Abnormality
Time frame: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)
Percentage of Participants With Blood Chemistry Laboratory Test Abnormality
Time frame: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)
Plasma Concentration at the End of Infusion (Cendinf) of Figitumumab
Time frame: 0.5 hour predose and 1 hour post-infusion on Day 1 of Cycles 1 and 4
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab
Time frame: 0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, 15, and 22 of Cycles 1 and 4
Area Under the Curve From Time Zero to Day 22 [AUC504] of Figitumumab
Time frame: 0.5 hour predose and 504 hours (Day 22) post-infusion of Cycles 1 and 4
Plasma Decay Half-Life (t1/2) of Figitumumab
Time frame: 0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, and 15 of Cycles 1 and 4
Maximum Observed Plasma Concentration (Cmax) of Sunitinib
Time frame: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib
Time frame: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1
Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of Sunitinib
Time frame: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1
Trough Plasma Concentration (Ctrough) of Sunitinib
Time frame: 0.5 hour predose on Day 1 of Cycle 2
Plasma Concentration at 24 Hours Postdose (C24) of Sunitinib
Time frame: 24 hours postdose on Day 15 of Cycle 1
Number of Participants With Anti-Drug Antibodies (ADA)
Time frame: 0.5 hour pre-infusion on Day 1 in Cycles 1 and 2, at end of treatment, and during the last scheduled follow-up visit (5 months from the last dose of study drug)
Number of Participants With Objective Response (OR)
Time frame: Baseline, Day 15 of every 2 cycles until disease progression up to follow-up (approximately 28 days following the last dose of study drug)

Results and safety

Results posted to the registry on 9 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Figitumumab 10 mg/kg + Sunitinib 25 mg CDD	20	0
Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD	7	0
Figitumumab 20 mg/kg + Sunitinib 25 mg CDD	12	0
Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1	6	0

Primary outcome: Number of Participants With Dose-Limiting Toxicities (DLT)

Time frame: Baseline up to the end of Cycle 1 (each cycle=3 weeks). Number. Unit: participants

Measure	Figitumumab 10 mg/kg + Sunitinib 25 mg CDD n = 20	Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD n = 7	Figitumumab 20 mg/kg + Sunitinib 25 mg CDD n = 12	Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1 n = 6
Value	0	1	3	1

Population analysed: Per-Protocol Analysis Set: All participants who started treatment and who did not have first cycle major treatment deviations.

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Figitumumab 10 mg/kg + Sunitinib 25 mg CDD	10 of 20 (50%)	20 of 20 (100%)	Not reported
Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD	3 of 7 (42.9%)	7 of 7 (100%)	Not reported
Figitumumab 20 mg/kg + Sunitinib 25 mg CDD	6 of 12 (50%)	12 of 12 (100%)	Not reported
Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1	5 of 6 (83.3%)	6 of 6 (100%)	Not reported

Limitations and caveats (from the sponsor): This study was terminated prematurely. Subsequently, ADA samples were not assayed and the pharmacokinetics of sunitinib plus its metabolite were not analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
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

4 sites 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-751,871 and Sunitinib in people with Advanced Cancer and Advanced Solid Tumors, run by Pfizer at 4 sites in United States.

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 9 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 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in 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 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 9 Jun 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?

Number of Participants With Dose-Limiting Toxicities (DLT) (time frame: Baseline up to the end of Cycle 1 (each cycle=3 weeks)). 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 NCT00729833.

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 9 Jun 2014.