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OpenTrials
Completed

NCT Number: NCT01192165

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trametinib (GSK1120212)

Drug

Investigational small molecule targeted therapy (MEK1/2 inhibitor)

docetaxel

Drug

Chemotherapy

Erlotinib

Drug

Small molecule targeted therapy (EGFR inhibitor)

Pemetrexed

Drug

Chemotherapy

carboplatin

Drug

Chemotherapy

Nab-paclitaxel

Drug

Chemotherapy

Cisplatin

Drug

Chemotherapy

Primary outcomes

  1. 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)

Secondary outcomes

  1. To characterize population pharmacokinetic parameters

    Time frame: Duration of study (approximately 3 years)

  2. 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)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 31, 2010
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.