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

Primary Purpose

Colorectal Cancer

Status

Unknown status

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

Dacomitinib

PD-0325901

Docetaxel

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Netherlands Cancer InstituteRecruiting
Erasmus Medical Center Cancer InstituteRecruiting
University Medical Center UtrechtRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dacomitinib + PD-0325901

Arm Description

Dacomitinib: oral tablets PD-0325901: oral capsules

Outcomes

Primary Outcome Measures

Incidence rate of dose-limiting toxicities

Progression free survival

Secondary Outcome Measures

Incidence and severity of adverse events

Plasma concentration

Overall response rate

Duration of response

Time to response

Overall survival

Full Information

NCT ID

NCT02039336

First Posted

January 15, 2014

Last Updated

August 24, 2018

Sponsor

The Netherlands Cancer Institute

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02039336

Brief Title

Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Netherlands Cancer Institute

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dacomitinib + PD-0325901

Arm Type

Experimental

Arm Description

Dacomitinib: oral tablets PD-0325901: oral capsules

Intervention Type

Drug

Intervention Name(s)

Dacomitinib

Intervention Type

Drug

Intervention Name(s)

PD-0325901

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Primary Outcome Measure Information:

Title

Incidence rate of dose-limiting toxicities

Time Frame

1.5 years

Title

Progression free survival

Time Frame

2.5 years

Secondary Outcome Measure Information:

Title

Incidence and severity of adverse events

Time Frame

2.5 years

Title

Plasma concentration

Time Frame

2.5 years

Title

Overall response rate

Time Frame

2.5 years

Title

Duration of response

Time Frame

1.5 years

Title

Time to response

Time Frame

2.5 years

Title

Overall survival

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

F Opdam, MD, PhD

Phone

0031205122446

f.opdam@nki.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

f opdam, MD, PhD

Organizational Affiliation

The Netherlands Cancer Institute

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

FALM Eskens, PhD

Organizational Affiliation

Erasmus Medical Centre Cancer Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

MPJK Lolkema, PhD

Organizational Affiliation

UMC Utrecht

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Netherlands Cancer Institute

City

Amsterdam

ZIP/Postal Code

1066CX

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

F opdam, MD, PhD

Phone

+31 20 512 2446

f.opdam@nki.nl

Facility Name

Erasmus Medical Center Cancer Institute

City

Rotterdam

ZIP/Postal Code

3015CE

Country

Netherlands

Individual Site Status

Recruiting

Facility Name

University Medical Center Utrecht

City

Utrecht

ZIP/Postal Code

3584CX

Country

Netherlands

Individual Site Status

Recruiting

12. IPD Sharing Statement

Citations:

PubMed Identifier

32147669

Citation

van Geel RMJM, van Brummelen EMJ, Eskens FALM, Huijberts SCFA, de Vos FYFL, Lolkema MPJK, Devriese LA, Opdam FL, Marchetti S, Steeghs N, Monkhorst K, Thijssen B, Rosing H, Huitema ADR, Beijnen JH, Bernards R, Schellens JHM. Phase 1 study of the pan-HER inhibitor dacomitinib plus the MEK1/2 inhibitor PD-0325901 in patients with KRAS-mutation-positive colorectal, non-small-cell lung and pancreatic cancer. Br J Cancer. 2020 Apr;122(8):1166-1174. doi: 10.1038/s41416-020-0776-z. Epub 2020 Mar 9.

Results Reference

derived

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Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC

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