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

Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192165
• Other study ID #: 113486
• Secondary ID: 2012-000257-32
• Status: Completed
• Phase: Phase 1
• First received: August 30, 2010
• Last updated: November 8, 2017
• Start date: September 14, 2010
• Est. completion date: October 7, 2013

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: October 7, 2013
• Est. primary completion date: October 7, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Trametinib (GSK1120212)
Investigational small molecule targeted therapy (MEK1/2 inhibitor)
• Docetaxel
Chemotherapy
• Erlotinib
Small molecule targeted therapy (EGFR inhibitor)
• Pemetrexed
Chemotherapy
• Carboplatin
Chemotherapy
• nab-Paclitaxel
Chemotherapy
• Cisplatin
Chemotherapy

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Toronto	Ontario
France	GSK Investigational Site	Caen Cedex 9
France	GSK Investigational Site	Marseille cedex 5
France	GSK Investigational Site	Saint-Herblain cedex
France	GSK Investigational Site	Toulouse cedex
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
United States	GSK Investigational Site	Albany	New York
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Duarte	California
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Scottsdale	Arizona
United States	GSK Investigational Site	Tyler	Texas
United States	GSK Investigational Site	Vancouver	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada,  France,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety, tolerability, and recommended phase II dosing regimen of each GSK1120212-based treatment combination		Duration of study (approximately 3 years)
Secondary	To characterize population pharmacokinetic parameters		Duration of study (approximately 3 years)
Secondary	To evaluate the anti-tumor activity as assessed by tumor response rate according to RECIST v1.1		Duration of study (approximately 3 years)

External Links

•   Results for study 113486 can be found on the GSK Clinical Study Register.