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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02039336
Recruitment Status : Unknown
Verified August 2018 by The Netherlands Cancer Institute.
Recruitment status was:  Recruiting
First Posted : January 17, 2014
Last Update Posted : August 27, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Dacomitinib Drug: PD-0325901 Drug: Docetaxel Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study With the Combination of Dacomitinib and PD-0325901 in Metastatic KRAS Mutation Positive Non-small Cell Lung Cancer
Study Start Date : January 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dacomitinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dacomitinib + PD-0325901
Dacomitinib: oral tablets PD-0325901: oral capsules
 Drug: Dacomitinib
Drug: PD-0325901
Drug: Docetaxel


Outcome Measures
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Primary Outcome Measures :
  1. Incidence rate of dose-limiting toxicities [ Time Frame: 1.5 years ]
  2. Progression free survival [ Time Frame: 2.5 years ]

Secondary Outcome Measures :
  1. Incidence and severity of adverse events [ Time Frame: 2.5 years ]
  2. Plasma concentration [ Time Frame: 2.5 years ]
  3. Overall response rate [ Time Frame: 2.5 years ]
  4. Duration of response [ Time Frame: 1.5 years ]
  5. Time to response [ Time Frame: 2.5 years ]
  6. Overall survival [ Time Frame: 3 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039336


Contacts
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Contact: F Opdam, MD, PhD 0031205122446 f.opdam@nki.nl

Locations
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Netherlands
The Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands, 1066CX
Contact: F opdam, MD, PhD    +31 20 512 2446    f.opdam@nki.nl   
Erasmus Medical Center Cancer Institute Recruiting
Rotterdam, Netherlands, 3015CE
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584CX
Sponsors and Collaborators
The Netherlands Cancer Institute
Pfizer
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT02039336    
Other Study ID Numbers: NL45985.031.13
First Posted: January 17, 2014    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Intestinal Diseases
Rectal Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action