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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: Carboplatin; Drug: Cisplatin; Drug: Trametinib (GSK1120212); Drug: nab-Paclitaxel; Drug: Pemetrexed; Drug: Erlotinib; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01192165

2012-000257-32 (EudraCT Number)

113486

Details and patient eligibility

About

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.

Enrollment: 169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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169 participants in 6 patient groups

Treatment Group 1

Experimental group

Description:

Trametinib plus Docetaxel

Treatment:

Drug: Docetaxel

Drug: Trametinib (GSK1120212)

Treatment Group 2

Experimental group

Description:

Trametinib plus Erlotinib

Treatment:

Drug: Erlotinib

Drug: Trametinib (GSK1120212)

Treatment Group 3

Experimental group

Description:

Trametinib plus Pemetrexed

Treatment:

Drug: Pemetrexed

Drug: Trametinib (GSK1120212)

Treatment Group 4

Experimental group

Description:

Trametinib plus Pemetrexed and Carboplatin

Treatment:

Drug: Pemetrexed

Drug: Carboplatin

Drug: Trametinib (GSK1120212)

Treatment Group 5

Experimental group

Description:

Trametinib plus nab-Paclitaxel

Treatment:

Drug: nab-Paclitaxel

Drug: Trametinib (GSK1120212)

Treatment Group 6

Experimental group

Description:

Trametinib plus Pemetrexed and Cisplatin

Treatment:

Drug: Cisplatin

Drug: Pemetrexed

Drug: Trametinib (GSK1120212)