Carcinoma, Non-Small-Cell LungPhase 1/2NCT00147537
Combination Study Of CP-751,871 With Paclitaxel And Carboplatin In Advanced Lung Cancer
A Phase 1/2 study testing CP-751,871, paclitaxel and carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer at 31 sites in 4 countries.
Trial summary
Phase 1b Dose Excalation/Expansion: Identify and characterize safety and tolerability of recommended phase 2 dose of CP-751,871 when administered with paclitaxel and carboplatin Phase 1b Erlotinib Extension: To characterize the safety and tolerability of CP751,871 when administered with paclitaxel, carboplatin and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- CP-751,871, paclitaxel and carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 31 sitesin 4 countries
- Study dates
- Feb 2005to Aug 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of advanced/metastatic lung cancer
Who cannot join
- Previous treatment with chemotherapy
- Uncontrolled diabetes
- History/active cardiovascular disease
Trial locations and contacts
31 sites in 4 countries.
31 sites in 4 countries
United States26 sites
Pfizer Investigational Site
Baltimore, Maryland, 21204
Pfizer Investigational Site
City of Saint Peters, Missouri, 63376
Pfizer Investigational Site
Corinth, Mississippi, 38834
Pfizer Investigational Site
Creve Coeur, Missouri, 63141
Pfizer Investigational Site
Greenbrae, California, 94904
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Jacksonville, Florida, 32224
Pfizer Investigational Site
Jeffersonville, Indiana, 47130
Pfizer Investigational Site
Los Angeles, California, 90048
Pfizer Investigational Site
Louisville, Kentucky, 40202
Pfizer Investigational Site
Louisville, Kentucky, 40207
Pfizer Investigational Site
Louisville, Kentucky, 40217
Pfizer Investigational Site
Louisville, Kentucky, 40241
Pfizer Investigational Site
Memphis, Tennessee, 38104
Pfizer Investigational Site
Memphis, Tennessee, 38120
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111
Pfizer Investigational Site
Rochester, Minnesota, 55905
Pfizer Investigational Site
Shelbyville, Kentucky, 40065
Pfizer Investigational Site
Southaven, Mississippi, 38671
Pfizer Investigational Site
St Louis, Missouri, 63110
Pfizer Investigational Site
The Bronx, New York, 10461
Pfizer Investigational Site
The Bronx, New York, 10467
Pfizer Investigational Site
Tucson, Arizona, 85719
Pfizer Investigational Site
Tucson, Arizona, 85724-5024
Pfizer Investigational Site
Tucson, Arizona, 85724
Spain3 sites
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08907
Pfizer Investigational Site
Madrid, Madrid, 28041
Pfizer Investigational Site
Seville, Sevilla, 41013
About this study
Official title: A Phase 1b Dose Escalation/Phase 2 Randomized, Non-Comparative, Multiple Center, Open Label Study Of CP 751,871 In Combination With Paclitaxel And Carboplatin And Of Paclitaxel And Carboplatin Alone As First Line Treatment For Advanced Non-Small Cell Lung Cancer
Phase 1b Dose Excalation/Expansion: Identify and characterize safety and tolerability of recommended phase 2 dose of CP-751,871 when administered with paclitaxel and carboplatin Phase 1b Erlotinib Extension: To characterize the safety and tolerability of CP751,871 when administered with paclitaxel, carboplatin and erlotinib.
Phase 2: To test the efficacy of CP-751,871 combined with paclitaxel and carboplatin in the treatment of advanced non-small cell lung cancer
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- CP-751,871, paclitaxel, carboplatin, erlotinib
- Keywords
- non-small cell lung cancer, chemotherapy, figitumumab, insulin-like growth 1 factor receptor, IGF-IR, monoclonal antibody
- 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-751,871Drug
Phase 2 Arm A:
CP-751,871 20 mg/kg IV over 2.5 hours up to 17 cycles
paclitaxelDrug
Phase 2 Arm A:
Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles
Phase 2 Arm B:
Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles
carboplatinDrug
Phase 2 Arm A:
Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles
Phase 2 Arm B:
Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles
CP-751,871Drug
Phase 1b Dose Escalation/Expansion: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles) Phase 1b Erlotinib Extension: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles)
paclitaxelDrug
Phase 1b Dose Escalation/Expansion: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles) Phase 1b Erlotinib Extension: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles)
carboplatinDrug
Phase 1b Dose Escalation/Expansion: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles) Phase 1b Erlotinib Extension: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles)
erlotinibDrug
Phase 1b Erlotinib Extension: erlotinib 150 mg/day orally every day (up to 17 cycles)
| Study group | Role | What they receive |
|---|---|---|
| Phase 2 (Arms A & B) | Experimental | CP-751,871 + paclitaxel + carboplatin Receives: Drug: CP-751,871; Drug: paclitaxel; Drug: carboplatin |
| Phase 1b | Experimental | 1. Phase 1b Dose Escalation /Expansion: CP-751,871 + paclitaxel + carboplatin
2. Phase 1b Erlotinib Extension: CP-751,871 + paclitaxel + carboplatin + erlotinib Receives: Drug: CP-751,871; Drug: paclitaxel; Drug: carboplatin; Drug: erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)of CP-751,871 in Combination With Paclitaxel and Carboplatin: Phase 1b
The maximum tolerated dose of CP-751,871 in combination with paclitaxel and carboplatin is the highest dose level below the Maximum Administered Dose (the dose level at which 2 or more out of 3 to 6 patients experience a Dose Limiting Toxicity at a dose level in Cycle 1) at which none or one out of 6 patients experience a Cycle 1 Dose Limiting Toxicity.
Measured: Start of treatment (baseline) up to the end of Cycle 1 (Day 21)
Recommended Phase 2 Dose (RP2D): Phase 1b
Measured: Start of treatment (baseline) up to the end of Cycle 1 (Day 21)
Objective Response Rate: Phase 2
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (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: Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Objective Response Rate in Non-Adenocarcinoma Participants: Phase 2
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (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: Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Secondary outcomes (29)
Objective Response Rate: Phase 1b
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (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: Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 1b
HAHA are indicators of immunogenicity to CP-751,871.
Measured: Day 1 pre-infusion of each cycle up to Cycle 17 (each cycle was 21 day), 150 days after the last CP-751,871 infusion, and last follow up visit (one year post last study dose)
Number of Circulating Endothelial Cells (CECs): Phase 1b
Measured: Day 1 pre-dose and Days 15 to 21 of Cycle 4
Number of Circulating Tumor-Related Cells (CTCs) and CTC Insulin-Like Growth Factor 1 Receptor (IGF-IR) Expression: Phase 1b
Blood samples were collected to enumerate the number of total CTCs and CTC insulin-like growth factor 1 receptor (IGF-IR) expression
Measured: Day 1 pre-dose and Days 15 to 21 of Cycle 4
Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 1 in Phase 1b
Measured: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 4 in Phase 1b
Measured: Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 1 in Phase 1b
AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)
Measured: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 1b
AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)
Measured: Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
Area Under the Curve From Time Zero Extrapolated to Infinite Time [AUCinf] for CP-751,871 for Cycle 1 in Phase 1b
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) extrapolated to infinite time.
Measured: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 1 in Phase 1b
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 4 in Phase 1b
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
CP-751,871 Concentration at 504 Hours Post Dose (C504) for Cycle 1 (End of the 21-day Cycle) in Phase 1b
Concentration at 504 hours post dose
Measured: Cycle 2 pre-infusion (which is the end of Cycle 1)
CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 1b
Concentration at 504 hours post dose
Measured: Cycle 5 pre-infusion (which is the end of Cycle 4)
Accumulation of CP-751,871 Ratio (Cycle 4 AUC504 / Cycle 1 AUC504) (Rac) in Phase 1b
Accumulation ratio (Cycle 4 AUC504 / Cycle 1 AUC504) (Rac)
Measured: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1). Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871(AUClast) for Cycle 1 in Phase 1b
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871 (AUClast) for Cycle 4 in Phase 1b
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 1 in Phase 1b
Maximum Observed Plasma Concentration
Measured: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 1b
Maximum Observed Plasma Concentration
Measured: Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is then end of Cycle 4)
Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 2
HAHA are indicators of immunogenicity to CP-751,871
Measured: Day 1 pre-infusion of each Cycle (each cycle was 21 day) up to Cycle 17 and 150 days after the last CP-751,871 infusion
M.D. Anderson Symptom Assessment Inventory (MDASI) in Phase 2
The MDASI is a 19-item questionnaire that assesses the severity of 13 symptoms over the past 24 hours, as well as how much the symptoms interfered with 6 areas of function (eg, walking, work, mood), when the symptom was "at its worst". Each item is scored from 0 to 10, with '0' indicating that the symptom was either not present or did not interfere with their activities, and '10' indicating that the symptom was "as bad as you can imagine" or "interfered completely" with their life. Total average score range: 0 to 10.
Measured: Day 1 pre-dose of Cycle 1, weekly for Cycle 1 and 2, monthly prior to each subsequent cycle (Cycle 3 up to Cycle 17, each cycle was 21 day), and follow up (one year post last study dose)
The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC-QLQ-C30/-LC13) in Phase 2
The QLQ-C30/-LC13 is a 43 item, self-administered questionnaire designed to assess health outcomes in clinical trials. In addition to global quality of life, the measure assesses 5 functional domains (physical, role, cognitive, emotional and social functioning) and specific symptoms (eg, nausea, pain). Each item is rated on a 1-4 scale with '1' representing "not at all" and '4' "very much". Within domains, items are scored to obtain a total score with higher scores representative of poorer HRQoL. Scale score range: 0 to 100.
Measured: Day 1 pre-dose of Cycle 1, monthly prior to each cycle (up to 17 cycles, each cycle was 21 day), and follow up (one year post last study dose)
Apparent Volume of CP-751,871 Distribution (Vd) for Cycle 4 in Phase 2
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
Clearance (CL) of CP-751,871 for Cycle 4 in Phase 2
Systemic clearance.
Measured: Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 2
AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)
Measured: Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 2
Concentration at 504 hours post dose
Measured: Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 2
Maximum Observed Plasma Concentration
Measured: Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
Progression-Free Survival (PFS): Phase 2
Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).
Measured: Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Time to Progression (TTP) in Phase 2
Time in months from start of study treatment to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).
Measured: Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Duration of Response (DR) in Phase 2
Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Measured: Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionAug 2011
- Study completionAug 2011
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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 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
- NCT00147537
- Sponsor's protocol ID
- A4021002
- Status last verified
- Oct 2013
- First submitted
- 2 Sep 2005
- Last updated
- 30 Oct 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 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Dose Escalation/Phase 2 Randomized, Non-Comparative, Multiple Center, Open Label Study Of CP 751,871 In Combination With Paclitaxel And Carboplatin And Of Paclitaxel And Carboplatin Alone As First Line Treatment For Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00147537
- Acronym / sponsor ID
- A4021002
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- non-small cell lung cancer, chemotherapy, figitumumab, insulin-like growth 1 factor receptor, IGF-IR, monoclonal antibody
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Posted 24 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1b Dose Excalation/Expansion: Identify and characterize safety and tolerability of recommended phase 2 dose of CP-751,871 when administered with paclitaxel and carboplatin Phase 1b Erlotinib Extension: To characterize the safety and tolerability of CP751,871 when administered with paclitaxel, carboplatin and erlotinib.
Phase 2: To test the efficacy of CP-751,871 combined with paclitaxel and carboplatin in the treatment of advanced non-small cell lung cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 2 (Arms A & B) | Experimental | Drug: CP-751,871, Drug: paclitaxel, Drug: carboplatinCP-751,871 + paclitaxel + carboplatin |
| Phase 1b | Experimental | Drug: CP-751,871, Drug: paclitaxel, Drug: carboplatin, Drug: erlotinib1. Phase 1b Dose Escalation /Expansion: CP-751,871 + paclitaxel + carboplatin 2. Phase 1b Erlotinib Extension: CP-751,871 + paclitaxel + carboplatin + erlotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of advanced/metastatic lung cancer
Key exclusion criteria (3 listed)
- Previous treatment with chemotherapy
- Uncontrolled diabetes
- History/active cardiovascular disease
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-751,871Phase 2 Arm A: CP-751,871 20 mg/kg IV over 2.5 hours up to 17 cycles | Drug | Phase 2 (Arms A & B) |
| paclitaxelPhase 2 Arm A: Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles Phase 2 Arm B: Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles | Drug | Phase 2 (Arms A & B) |
| carboplatinPhase 2 Arm A: Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles Phase 2 Arm B: Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles | Drug | Phase 2 (Arms A & B) |
| CP-751,871Phase 1b Dose Escalation/Expansion: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles) Phase 1b Erlotinib Extension: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles) | Drug | Phase 1b |
| paclitaxelPhase 1b Dose Escalation/Expansion: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles) Phase 1b Erlotinib Extension: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles) | Drug | Phase 1b |
| carboplatinPhase 1b Dose Escalation/Expansion: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles) Phase 1b Erlotinib Extension: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles) | Drug | Phase 1b |
| erlotinibPhase 1b Erlotinib Extension: erlotinib 150 mg/day orally every day (up to 17 cycles) | Drug | Phase 1b |
Primary outcome
Maximum Tolerated Dose (MTD)of CP-751,871 in Combination With Paclitaxel and Carboplatin: Phase 1b
Time frame: Start of treatment (baseline) up to the end of Cycle 1 (Day 21)
The maximum tolerated dose of CP-751,871 in combination with paclitaxel and carboplatin is the highest dose level below the Maximum Administered Dose (the dose level at which 2 or more out of 3 to 6 patients experience a Dose Limiting Toxicity at a dose level in Cycle 1) at which none or one out of 6 patients experience a Cycle 1 Dose Limiting Toxicity.
Recommended Phase 2 Dose (RP2D): Phase 1b
Time frame: Start of treatment (baseline) up to the end of Cycle 1 (Day 21)
Objective Response Rate: Phase 2
Time frame: Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (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.
Objective Response Rate in Non-Adenocarcinoma Participants: Phase 2
Time frame: Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (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.
29 secondary outcomes
Objective Response Rate: Phase 1b
Time frame: Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 1b
Time frame: Day 1 pre-infusion of each cycle up to Cycle 17 (each cycle was 21 day), 150 days after the last CP-751,871 infusion, and last follow up visit (one year post last study dose)
Number of Circulating Endothelial Cells (CECs): Phase 1b
Time frame: Day 1 pre-dose and Days 15 to 21 of Cycle 4
Number of Circulating Tumor-Related Cells (CTCs) and CTC Insulin-Like Growth Factor 1 Receptor (IGF-IR) Expression: Phase 1b
Time frame: Day 1 pre-dose and Days 15 to 21 of Cycle 4
Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 1 in Phase 1b
Time frame: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 4 in Phase 1b
Time frame: Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 1 in Phase 1b
Time frame: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 1b
Time frame: Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
Area Under the Curve From Time Zero Extrapolated to Infinite Time [AUCinf] for CP-751,871 for Cycle 1 in Phase 1b
Time frame: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 1 in Phase 1b
Time frame: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 4 in Phase 1b
Time frame: Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
CP-751,871 Concentration at 504 Hours Post Dose (C504) for Cycle 1 (End of the 21-day Cycle) in Phase 1b
Time frame: Cycle 2 pre-infusion (which is the end of Cycle 1)
CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 1b
Time frame: Cycle 5 pre-infusion (which is the end of Cycle 4)
Accumulation of CP-751,871 Ratio (Cycle 4 AUC504 / Cycle 1 AUC504) (Rac) in Phase 1b
Time frame: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1). Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871(AUClast) for Cycle 1 in Phase 1b
Time frame: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871 (AUClast) for Cycle 4 in Phase 1b
Time frame: Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 1 in Phase 1b
Time frame: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 1b
Time frame: Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is then end of Cycle 4)
Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 2
Time frame: Day 1 pre-infusion of each Cycle (each cycle was 21 day) up to Cycle 17 and 150 days after the last CP-751,871 infusion
M.D. Anderson Symptom Assessment Inventory (MDASI) in Phase 2
Time frame: Day 1 pre-dose of Cycle 1, weekly for Cycle 1 and 2, monthly prior to each subsequent cycle (Cycle 3 up to Cycle 17, each cycle was 21 day), and follow up (one year post last study dose)
The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC-QLQ-C30/-LC13) in Phase 2
Time frame: Day 1 pre-dose of Cycle 1, monthly prior to each cycle (up to 17 cycles, each cycle was 21 day), and follow up (one year post last study dose)
Apparent Volume of CP-751,871 Distribution (Vd) for Cycle 4 in Phase 2
Time frame: Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
Clearance (CL) of CP-751,871 for Cycle 4 in Phase 2
Time frame: Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 2
Time frame: Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 2
Time frame: Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 2
Time frame: Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
Progression-Free Survival (PFS): Phase 2
Time frame: Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Time to Progression (TTP) in Phase 2
Time frame: Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Duration of Response (DR) in Phase 2
Time frame: Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 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
31 sites in 4 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, paclitaxel and carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer at 31 sites in 4 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 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 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Spain, Canada, Italy. 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 24 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?
Maximum Tolerated Dose (MTD)of CP-751,871 in Combination With Paclitaxel and Carboplatin: Phase 1b (time frame: Start of treatment (baseline) up to the end of Cycle 1 (Day 21)). The study lists 4 primary outcomes in all. 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 30 Oct 2013.