Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-02

Study Completion Date

2018-08-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer

NCT00077259

Colorectal Cancer

COMPLETED PHASE2

Savolitinib in Treating Patients With MET Amplified Metastatic or Unresectable Colorectal Cancer

NCT03592641

Colorectal Carcinoma Metastatic Colon Adenocarcinoma Metastatic Rectal Adenocarcinoma +18 more

TERMINATED PHASE2

Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials

NCT03350412

Metastatic Colorectal Cancer

UNKNOWN

Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers

NCT04491955

Small Bowel Cancers Colorectal Cancers

COMPLETED PHASE2

Randomized Trial With Dendritic Cells in Patients With Metastatic Colorectal Cancer

NCT01413295

Colorectal Neoplasms

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dacomitinib + PD-0325901

Dacomitinib: oral tablets PD-0325901: oral capsules

Group Type EXPERIMENTAL

Dacomitinib

Intervention Type DRUG

PD-0325901

Intervention Type DRUG

Docetaxel

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dacomitinib

Intervention Type DRUG

PD-0325901

Intervention Type DRUG

Docetaxel

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No