Carcinoma, Non-Small-Cell LungPhase 1NCT00603538

Study of CP-751,871 in Combination With Carboplatin and Paclitaxel in Advanced Lung Cancer

A Phase 1 study testing CP-751,871 + carboplatin + paclitaxel in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Investigate safety, tolerability and pharmacokinetics of CP-751,871 when given in combination with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer Read more about this study

Who is it for?: Ages 20 to 74 years
Conditions the study is for: Carcinoma, Non-Small-Cell Lung
What is being tested?: CP-751,871 + carboplatin + paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteJapan
Study dates: Jan 2008to May 2009
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 20 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of advanced non-small cell lung cancer
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Who cannot join

Any prior treatment for non-small cell lung cancer
Brain metastases
With diabetes

Trial locations and contacts

1 site in 1 country.

Japan1 site

Pfizer Investigational Site
Chuo-ku, Tokyo

Other trials in Japan

About this study

Official title: Phase 1, Dose Escalation Study of CP-751,871 in Combination With Carboplatin and Paclitaxel in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer

Investigate safety, tolerability and pharmacokinetics of CP-751,871 when given in combination with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung
Being tested: CP-751,871 + carboplatin + paclitaxel
Keywords: CP-751,871, Non-small cell lung cancer, Phase 1
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

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

CP-751,871 + carboplatin + paclitaxelDrug
Chemotherapy (carboplatin and paclitaxel) and CP-751,871 (6, 10 or 20mg/kg) will be administered by intravenous infusion every three weeks.

Study groups in NCT00603538
Study group	Role	What they receive
CP-751,871	Experimental	Not described Receives: Drug: CP-751,871 + carboplatin + paclitaxel

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)
A DLT was defined as any one of the following adverse events observed in Cycle 1 which was considered as related to CP-751,871 combination therapy; 1) >=Grade 3 gastrointestinal toxicity, hyperglycemia and/or fatigue despite the use of adequate/optimal medical intervention, 2) Any other >=Grade 3 toxicity not classified under CTCAE blood/bone marrow, or 3) Grade 4 neutropenia that persisted for >=7 consecutive days or was complicated by fever (defined as a body temperature >38.0 Celsius degree), 4) Grade 3 thrombocytopenia which needed blood transfusion or Grade 4 thrombocytopenia.
Measured: Cycle 1

Secondary outcomes (10)

Maximum Observed Concentration (Cmax) of CP-751,871
Measured: Cycles 1 and 4 at prior to dosing of CP-751,871 (Day 1), and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Cycle 1 : prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion
Area Under the Plasma Concentration-time Curve From Time 0 to Day 22 (AUC0-day22)
AUC(0-day22) : AUC from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sampling for the next cycle. AUC(0-day22) was calculated using the linear/log trapezoidal method.
Measured: Cycle 1: prior CP-751,871 (Day 1) to dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion
Area Under the Plasma Concentration Curve From Time Zero to Tau (AUCtau)
AUCtau: AUC from time zero to tau, the dosing interval, where tau is the actual time of the predose sampling for the next cycle. AUCtau was calculated using the linear/log trapezoidal method.
Measured: Cycle 4: prior to CP-751,871 (Day 1) dosing , and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion
Observed Accumulation Ratio (Rac)
The ratio of Cycle 4 AUCtau to Cycle 1 AUCtau
Measured: Cycle 1 and Cycle 4: prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion
Serum Concentrations of Total Insulin-like Growth Factor 1 (IGF-1)
IGF-1 is one of the IGF-axis related biomarkers.
Measured: Day 1 of Cycles 1 to 6, Day 8 of Cycles 1 to 4, and end of study
Serum Concentrations of Total Insulin-like Growth Factor Binding Protein-3 (IGF-BP-3)
IGF-BP3 is one of the IGF-axis related biomarkers.
Measured: Day 1 of Cycles 1-6, Day 8 of Cycles 1-4, and end of treatment
Number of Participants With Positive Anti-Drug Antibody (ADA) Specific to CP-751,871 Following an Intravenous Infusion of CP-751,871.
The screening assay for anti-CP-751,871 antibodies was performed.
Measured: Day 1 of Cycles 1 (predose) and 4, and end of study
Number of Participants With Objective Response
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.
Measured: Baseline up to 6 cycles (1 cycle = 21 days)
Progression-Free Survival (PFS)
PFS is the period from the registration to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
Measured: Baseline up to 6 cycles (1 cycle = 21 days)

Timeline

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

Jan 2008May 2009

First posted29 Jan 2008 (estimated)
Study startJan 2008
Primary completionMay 2009
Study completionMay 2009

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 Carcinoma, Non-Small-Cell LungStudies 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: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00603538
Sponsor's protocol ID: A4021019
Other IDs: Japan CTPN 19-2409
Status last verified: Mar 2013
First submitted: 17 Jan 2008
Last updated: 11 Apr 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Goto Y, Sekine I, Tanioka M, Shibata T, Tanai C, Asahina H, Nokihara H, Yamamoto N, Kunitoh H, Ohe Y, Kikkawa H, Ohki E, Tamura T. Figitumumab combined with carboplatin and paclitaxel in treatment-naive Japanese patients with advanced non-small cell lung cancer. Invest New Drugs. 2012 Aug;30(4):1548-56. doi: 10.1007/s10637-011-9715-4. Epub 2011 Jul 13.
PubMed 21748299

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 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1, Dose Escalation Study of CP-751,871 in Combination With Carboplatin and Paclitaxel in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00603538
Acronym / sponsor ID: A4021019
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: CP-751,871, Non-small cell lung cancer, Phase 1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 29 Jan 2008 (estimated)
Results: Posted 11 Apr 2013

Clinical summary

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

Investigate safety, tolerability and pharmacokinetics of CP-751,871 when given in combination with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer

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	Experimental	Drug: CP-751,871 + carboplatin + paclitaxel

Who may qualify

Ages: 20 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis of advanced non-small cell lung cancer
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Key exclusion criteria (3 listed)

Any prior treatment for non-small cell lung cancer
Brain metastases
With diabetes

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-751,871 + carboplatin + paclitaxelChemotherapy (carboplatin and paclitaxel) and CP-751,871 (6, 10 or 20mg/kg) will be administered by intravenous infusion every three weeks.	Drug	CP-751,871

Primary outcome

Number of Participants With Dose Limiting Toxicities (DLT)
Time frame: Cycle 1
A DLT was defined as any one of the following adverse events observed in Cycle 1 which was considered as related to CP-751,871 combination therapy; 1) >=Grade 3 gastrointestinal toxicity, hyperglycemia and/or fatigue despite the use of adequate/optimal medical intervention, 2) Any other >=Grade 3 toxicity not classified under CTCAE blood/bone marrow, or 3) Grade 4 neutropenia that persisted for >=7 consecutive days or was complicated by fever (defined as a body temperature >38.0 Celsius degree), 4) Grade 3 thrombocytopenia which needed blood transfusion or Grade 4 thrombocytopenia.

10 secondary outcomes

Maximum Observed Concentration (Cmax) of CP-751,871
Time frame: Cycles 1 and 4 at prior to dosing of CP-751,871 (Day 1), and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion
Plasma Decay Half-Life (t1/2)
Time frame: Cycle 1 : prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion
Area Under the Plasma Concentration-time Curve From Time 0 to Day 22 (AUC0-day22)
Time frame: Cycle 1: prior CP-751,871 (Day 1) to dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion
Area Under the Plasma Concentration Curve From Time Zero to Tau (AUCtau)
Time frame: Cycle 4: prior to CP-751,871 (Day 1) dosing , and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion
Observed Accumulation Ratio (Rac)
Time frame: Cycle 1 and Cycle 4: prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion
Serum Concentrations of Total Insulin-like Growth Factor 1 (IGF-1)
Time frame: Day 1 of Cycles 1 to 6, Day 8 of Cycles 1 to 4, and end of study
Serum Concentrations of Total Insulin-like Growth Factor Binding Protein-3 (IGF-BP-3)
Time frame: Day 1 of Cycles 1-6, Day 8 of Cycles 1-4, and end of treatment
Number of Participants With Positive Anti-Drug Antibody (ADA) Specific to CP-751,871 Following an Intravenous Infusion of CP-751,871.
Time frame: Day 1 of Cycles 1 (predose) and 4, and end of study
Number of Participants With Objective Response
Time frame: Baseline up to 6 cycles (1 cycle = 21 days)
Progression-Free Survival (PFS)
Time frame: Baseline up to 6 cycles (1 cycle = 21 days)

Results and safety

Results posted to the registry on 11 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CP-751,871 6 mg/kg in Combination With Chemotherapy Agents	6	3
CP-751,871 10 mg/kg in Combination With Chemotherapy Agents	7	3
CP-751,871 20 mg/kg in Combination With Chemotherapy Agents	6	4

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

Time frame: Cycle 1. Number. Unit: participants

Measure	CP-751,871 6 mg/kg in Combination With Chemotherapy Agents n = 6	CP-751,871 10 mg/kg in Combination With Chemotherapy Agents n = 6	CP-751,871 20 mg/kg in Combination With Chemotherapy Agents n = 6
Value	1	2	0

Population analysed: DLT Evaluation Set comprised of participants who were treated with CP-751,871. One participant in the 10 mg/kg cohort who discontinued from the study due to an adverse event occurred prior to CP-751,871 administration was excluded from this analysis set.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: For serious adverse events, up to 150 days after the last administration of the study drugs. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CP-751,871 6 mg/kg in Combination With Chemotherapy Agents	0 of 6 (0%)	6 of 6 (100%)	Not reported
CP-751,871 10 mg/kg in Combination With Chemotherapy Agents	1 of 7 (14.3%)	6 of 7 (85.7%)	Not reported
CP-751,871 20 mg/kg in Combination With Chemotherapy Agents	1 of 6 (16.7%)	6 of 6 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21748299Goto Y, Sekine I, Tanioka M, Shibata T, Tanai C, Asahina H, Nokihara H, Yamamoto N, Kunitoh H, Ohe Y, Kikkawa H, Ohki E, Tamura T. Figitumumab combined with carboplatin and paclitaxel in treatment-naive Japanese patients with advanced non-small cell lung cancer. Invest New Drugs. 2012 Aug;30(4):1548-56. doi: 10.1007/s10637-011-9715-4. Epub 2011 Jul 13.
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

1 site 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 + carboplatin + paclitaxel in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer at 1 site in Japan.

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 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 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. 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 11 Apr 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 Dose Limiting Toxicities (DLT) (time frame: Cycle 1). 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 NCT00603538, 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 11 Apr 2013.