Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lung Neoplasms

Adenocarcinoma

Recurrence

Adenocarcinoma of Lung

Disease Attributes

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Lung Adenocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Trametinib

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Phase 1: Accrue 6 patients on Trametinib 1.5mg + Erlotinib 75mg by mouth once daily Phase 2: Accrue 24 patients (including 6 patients treated during Phase 1) on Trametinib 1.5mg + Erlotinib 75mg by mouth once daily or Trametinib 1.0mg + Erlotinib 100mg by mouth once daily.

Erlotinib

Helena Yu, MD

The purpose of this study is to determine the safety, tolerability and overall response rate of trametinib when given in combination with erlotinib in patients with Stage IV or recurrent lung adenocarcinoma that cannot be treated with curative intent.

A Phase 1/2 Trial of Trametinib and Erlotinib in Patients With EGFR-Mutant Lung Adenocarcinomas and Acquired Resistance to Erlotinib

Response and progression of disease will be evaluated in this study using interval imaging every 8 weeks with CT scan of the chest and imaging of any other target lesion with response evaluated by RECIST 1.1.

Safety and tolerability will be evaluated by systematic and regular toxicity evaluations. Toxicity will be graded according to NCI CTCAE version 4.0.

GlaxoSmithKline

Memorial Sloan Kettering Cancer Center

Phase 1: Accrue 6 patients on Trametinib 1.5mg + Erlotinib 75mg by mouth once daily Phase 2: Accrue 24 patients (including 6 patients treated during Phase 1) daily doses of 75mg erlotinib and 1.5mg trametinib

This treatment regimen was already assessed in a previous study. The phase 1 portion was a safety lead-in of a slight modification of the previously established combination dosing. As a consequence, we only did a safety lead in of one dose level that was determined to be the phase 2 dose and we rolled all the phase 1 patients into the phase 2 cohort.

Trametinib 1.5mg + Erlotinib 75mg

Phase 1: Accrue 6 patients on Trametinib 1.5mg + Erlotinib 75mg by mouth once daily Phase 2: Accrue 24 patients (including 6 patients treated during Phase 1) daily doses of 75mg erlotinib and 1.5mg trametinib This treatment regimen was already assessed in a previous study. The phase 1 portion was a safety lead-in of a slight modification of the previously established combination dosing. As a consequence, we only did a safety lead in of one dose level that was determined to be the phase 2 dose and we rolled all the phase 1 patients into the phase 2 cohort.

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Helene Yu, MD

Stable Disease

Progression of disease

Not Entered

Partial Response

Phase 1: Accrue 6 patients on Trametinib 1.5mg + Erlotinib 75mg by mouth once daily Phase 2: Accrue 24 patients (including 6 patients treated during Phase 1) daily doses of 75mg erlotinib and 1.5mg trametinib

This treatment regimen was already assessed in a previous study. The phase 1 portion was a safety lead-in of a slight modification of the previously established combination dosing. As a consequence, we only did a safety lead in of one dose level that was determined to be the phase 2 dose and we rolled all the phase 1 patients into the phase 2 cohort. There would be no reason or utility to assess the phase 1 cohort separately since they received the same dose as the phase 2 cohort.

Participants Response Rate

Number of Participants Evaluated for Toxicities

Overall Study

Spots Global Cancer Trial Database for A Phase 1/2 Trial of Trametinib and Erlotinib in Patients With EGFR-Mutant Lung Adenocarcinomas and Acquired Resistance to Erlotinib

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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