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Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC (M13DAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02039336
Recruitment Status : Recruiting
First Posted : January 17, 2014
Last Update Posted : August 27, 2018
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Tracking Information
First Submitted Date  ICMJE January 15, 2014
First Posted Date  ICMJE January 17, 2014
Last Update Posted Date August 27, 2018
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2014)
  • Incidence rate of dose-limiting toxicities [ Time Frame: 1.5 years ]
  • Progression free survival [ Time Frame: 2.5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02039336 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2014)
  • Incidence and severity of adverse events [ Time Frame: 2.5 years ]
  • Plasma concentration [ Time Frame: 2.5 years ]
  • Overall response rate [ Time Frame: 2.5 years ]
  • Duration of response [ Time Frame: 1.5 years ]
  • Time to response [ Time Frame: 2.5 years ]
  • Overall survival [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC
Official Title  ICMJE Phase I/II Study With the Combination of Dacomitinib and PD-0325901 in Metastatic KRAS Mutation Positive Non-small Cell Lung Cancer
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: Dacomitinib
  • Drug: PD-0325901
  • Drug: Docetaxel
Study Arms  ICMJE Experimental: Dacomitinib + PD-0325901
Dacomitinib: oral tablets PD-0325901: oral capsules
  • Drug: Dacomitinib
  • Drug: PD-0325901
  • Drug: Docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2014)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: F Opdam, MD, PhD 0031205122446
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02039336
Other Study ID Numbers  ICMJE NL45985.031.13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Netherlands Cancer Institute
Study Sponsor  ICMJE The Netherlands Cancer Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: f opdam, MD, PhD The Netherlands Cancer Institute
Principal Investigator: FALM Eskens, PhD Erasmus Medical Centre Cancer Institute
Principal Investigator: MPJK Lolkema, PhD UMC Utrecht
PRS Account The Netherlands Cancer Institute
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP