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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00603538
First received: January 17, 2008
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: CP-751,871 + carboplatin + paclitaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Dose Limiting Toxicities (DLT) [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    The ratio of Cycle 4 AUCtau to Cycle 1 AUCtau

  • 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 ] [ Designated as safety issue: No ]
    IGF-1 is one of the IGF-axis related biomarkers.

  • 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 ] [ Designated as safety issue: No ]
    IGF-BP3 is one of the IGF-axis related biomarkers.

  • 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 ] [ Designated as safety issue: No ]
    The screening assay for anti-CP-751,871 antibodies was performed.

  • Number of Participants With Objective Response [ Time Frame: Baseline up to 6 cycles (1 cycle = 21 days) ] [ Designated as safety issue: No ]
    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.

  • Progression-Free Survival (PFS) [ Time Frame: Baseline up to 6 cycles (1 cycle = 21 days) ] [ Designated as safety issue: No ]
    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.


Enrollment: 19
Study Start Date: January 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CP-751,871 Drug: CP-751,871 + carboplatin + paclitaxel
Chemotherapy (carboplatin and paclitaxel) and CP-751,871 (6, 10 or 20mg/kg) will be administered by intravenous infusion every three weeks.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603538

Locations
Japan
Pfizer Investigational Site
Chuo-ku, Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00603538     History of Changes
Other Study ID Numbers: A4021019, Japan CTPN 19-2409
Study First Received: January 17, 2008
Results First Received: January 18, 2013
Last Updated: March 5, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:
CP-751,871, Non-small cell lung cancer, Phase 1

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 22, 2014