Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer

Randomized, Open Label, Phase 3 Clinical Study To Evaluate The Effect Of The Addition Of CP-751,871 To Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00907504

Acronym

ADVIGO1017

Enrollment

Registered

2009-05-22

Start date

2010-07-31

Completion date

2014-05-31

Last updated

2014-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Brief summary

Gemcitabine and cisplatin given together is a standard treatment option for advanced lung cancer patients. The purpose of this study is to assess if the life span is longer in patients taking the investigational drug CP-751,871 in combination with gemcitabine and cisplatin compared to gemcitabine and cisplatin alone. Considering a 10% rate of drop-outs, 1,210 participants will be required in order to have an adequate sample size (1,100 evaluable patients) and power to detect a 30% prolongation of survival on the experimental arm.

Interventions

DRUGCP-751,871

CP-751,871 20mg/kg every 3 weeks

DRUGCisplatin

Cisplatin 80 mg/m2 every 3 weeks

DRUGGemcitabine

Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Non-Small Cell Lung Cancer (NSCLC), advanced, chemotherapy-naive * Male or female \> 18 years * Eastern Oncology Cooperative Group (ECOG) Performance Status (PS) 0 or 1 * Adequate organ function

Exclusion criteria

* Uncontrolled hypertension or diabetes; * Pregnant female; * Symptomatic Central Nervous System (CNS) metastasis, requirement for chronic corticosteroids.

Design outcomes

Primary

Measure	Time frame
Overall Survival	Dec 2012

Secondary

Measure	Time frame
Objective Response	Dec 2011
Overall Safety Profile	Dec 2012
Patient Reported Outcome	Dec 2012
Progression Free survival	Dec 2011
Anti-drug Antibody	Dec 2012
Biomarker Analysis	Dec 2012
Pharmacokinetics	Dec 2012

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026