Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC

Colorectal Cancer Clinical Trial

— M13DAP  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT02039336
• Other study ID #: NL45985.031.13
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 2014
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: The Netherlands Cancer Institute
• Contact: F Opdam, MD, PhD
• Phone: 0031205122446
• Email: f.opdam[@]nki.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Dacomitinib

• PD-0325901

• Docetaxel

Locations

Country	Name	City	State
Netherlands	The Netherlands Cancer Institute	Amsterdam
Netherlands	Erasmus Medical Center Cancer Institute	Rotterdam
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	Pfizer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of dose-limiting toxicities		1.5 years
Primary	Progression free survival		2.5 years
Secondary	Incidence and severity of adverse events		2.5 years
Secondary	Plasma concentration		2.5 years
Secondary	Overall response rate		2.5 years
Secondary	Duration of response		1.5 years
Secondary	Time to response		2.5 years
Secondary	Overall survival		3 years