Skip to main content
OpenTrials
Completed

NCT Number: NCT00603538

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Chuo-ku, Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

CP-751,871 + carboplatin + paclitaxel

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  3. 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

    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.

  4. 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

    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.

  5. 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

    The ratio of Cycle 4 AUCtau to Cycle 1 AUCtau

  6. 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

    IGF-1 is one of the IGF-axis related biomarkers.

  7. 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

    IGF-BP3 is one of the IGF-axis related biomarkers.

  8. 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

    The screening assay for anti-CP-751,871 antibodies was performed.

  9. Number of Participants With Objective Response

    Time frame: Baseline up to 6 cycles (1 cycle = 21 days)

    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.

  10. Progression-Free Survival (PFS)

    Time frame: Baseline up to 6 cycles (1 cycle = 21 days)

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 29, 2008
Registry last updated
Apr 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.