Safety and Tolerability Study of GSK1120212, a MEK Inhibitor, in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel

November 8, 2017 updated by: GlaxoSmithKline

An Open-Label, Phase I/Ib Dose Escalation Study to Assess the Safety and Tolerability of GSK1120212 in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel in Subjects With Advanced Solid Tumors

The purpose of this study is to determine what dose of GSK1120212 can be given safely in combination with at least one other drug that is already approved to treat cancer. This study will test the safety of up to 6 different GSK1120212 study treatment combinations (GSK1120212 plus either docetaxel, erlotinib, pemetrexed, pemetrexed + carboplatin, pemetrexed + cisplatin, or nab-paclitaxel). The doses identified in this study may be used in future trials to test whether the combination treatment is a safe and effective therapy for subjects with metastatic lung and/or pancreatic cancers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
169

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • GSK Investigational Site
  • France
      • Caen Cedex 9, France, 14033
        • GSK Investigational Site
      • Marseille cedex 5, France, 13385
        • GSK Investigational Site
      • Saint-Herblain cedex, France, 44805
        • GSK Investigational Site
      • Toulouse cedex, France, 31052
        • GSK Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • GSK Investigational Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • GSK Investigational Site
    • California
      • Duarte, California, United States, 91010
        • GSK Investigational Site
      • Sacramento, California, United States, 95817
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80218
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • GSK Investigational Site
    • New York
      • Albany, New York, United States, 12206
        • GSK Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75246
        • GSK Investigational Site
      • Houston, Texas, United States, 77030
        • GSK Investigational Site
      • Tyler, Texas, United States, 75702
        • GSK Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • GSK Investigational Site
    • Washington
      • Vancouver, Washington, United States, 98684
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subject has a solid tumor. Expansion cohorts are limited to non-small cell lung cancer and/or pancreatic cancer with or without a KRAS mutation.
  • Tumor progression following at least one prior standard therapy, the subject refuses standard therapy, or no standard therapy exists.
  • The subject has a radiographically measurable tumor.
  • The subject is able to carry out daily life activities without difficulty.
  • The subject is able to swallow and retain oral medication.
  • The subject does not have significant side effects from previous anti-cancer treatment.
  • The subject has adequate organ and blood cell counts.
  • Sexually active subjects must use medically acceptable methods of contraception during the course of the study.

Exclusion Criteria:

  • The subject has had major surgery or received certain types of cancer therapy within 2-3 weeks before starting the study.
  • The subject has a brain tumor.
  • Current severe, uncontrolled systemic disease.
  • History of clinically significant heart, lung, or eye/vision problems.
  • The subject has high blood pressure that is not well-controlled with medication.
  • The subject has a permanent pacemaker.
  • The subject is pregnant or breastfeeding.
  • Positive for Hepatitis B, Hepatitis C, or HIV.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group 1
Trametinib plus Docetaxel
Drug: Docetaxel
Chemotherapy
Drug: Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor)
Experimental: Treatment Group 2
Trametinib plus Erlotinib
Drug: Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor)
Drug: Erlotinib
Small molecule targeted therapy (EGFR inhibitor)
Experimental: Treatment Group 3
Trametinib plus Pemetrexed
Drug: Pemetrexed
Chemotherapy
Drug: Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor)
Experimental: Treatment Group 4
Trametinib plus Pemetrexed and Carboplatin
Drug: Pemetrexed
Chemotherapy
Drug: Carboplatin
Chemotherapy
Drug: Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor)
Experimental: Treatment Group 5
Trametinib plus nab-Paclitaxel
Drug: nab-Paclitaxel
Chemotherapy
Drug: Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor)
Experimental: Treatment Group 6
Trametinib plus Pemetrexed and Cisplatin
Drug: Pemetrexed
Chemotherapy
Drug: Cisplatin
Chemotherapy
Drug: Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To determine the safety, tolerability, and recommended phase II dosing regimen of each GSK1120212-based treatment combination
Time Frame: Duration of study (approximately 3 years)
Duration of study (approximately 3 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To characterize population pharmacokinetic parameters
Time Frame: Duration of study (approximately 3 years)
Duration of study (approximately 3 years)
To evaluate the anti-tumor activity as assessed by tumor response rate according to RECIST v1.1
Time Frame: Duration of study (approximately 3 years)
Duration of study (approximately 3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 7, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 7, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 113486
  • 2012-000257-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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