Clinical Trials /

Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC

NCT02039336

Description:

This is a phase I/II multi-center open-label proof of concept study, consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of the combination regimen of dacomitinib plus PD-0325901 in patients with advanced KRAS mutant (KRASm) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the combination of dacomitinib and PD-0325901 versus standard of care therapy in patients with advanced KRASm NSCLC. It is hypothesized that with this combination strategy the progression free survival of patients with KRASm NSCLC will be doubled.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC
  • Official Title: Phase I/II Study With the Combination of Dacomitinib and PD-0325901 in Metastatic KRAS Mutation Positive Non-small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: NL45985.031.13
  • NCT ID: NCT02039336

Conditions

  • Colorectal Cancer

Interventions

DrugSynonymsArms
DacomitinibDacomitinib + PD-0325901
PD-0325901Dacomitinib + PD-0325901
DocetaxelDacomitinib + PD-0325901

Purpose

This is a phase I/II multi-center open-label proof of concept study, consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of the combination regimen of dacomitinib plus PD-0325901 in patients with advanced KRAS mutant (KRASm) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the combination of dacomitinib and PD-0325901 versus standard of care therapy in patients with advanced KRASm NSCLC. It is hypothesized that with this combination strategy the progression free survival of patients with KRASm NSCLC will be doubled.

Trial Arms

NameTypeDescriptionInterventions
Dacomitinib + PD-0325901ExperimentalDacomitinib: oral tablets PD-0325901: oral capsules
  • Dacomitinib
  • PD-0325901
  • Docetaxel

Eligibility Criteria

        Inclusion Criteria:

          -  Histological or cytological proof of advanced non-small cell lung cancer

          -  Written documentation of KRAS (exon 2, 3 or 4) mutation

          -  At least 18 years of age or older

          -  Able and willing to give written informed consent

          -  WHO performance status of 0 or 1

        Exclusion Criteria:

          -  Symptomatic or untreated leptomeningeal disease

          -  Symptomatic brain metastasis

          -  Impairment of gastrointestinal function

          -  Uncontrolled infectious disease

          -  Left ventricular ejection fraction < 50%

          -  Retinal degenerative disease or with history of uveitis, retinal vein occlusion or
             retinal detachment

        Other protocol-defined inclusion/exclusion criteria may apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence rate of dose-limiting toxicities
Time Frame:1.5 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence and severity of adverse events
Time Frame:2.5 years
Safety Issue:
Description:
Measure:Plasma concentration
Time Frame:2.5 years
Safety Issue:
Description:
Measure:Overall response rate
Time Frame:2.5 years
Safety Issue:
Description:
Measure:Duration of response
Time Frame:1.5 years
Safety Issue:
Description:
Measure:Time to response
Time Frame:2.5 years
Safety Issue:
Description:
Measure:Overall survival
Time Frame:3 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:The Netherlands Cancer Institute

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