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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety, tolerability, and recommended phase II dosing regimen of each GSK1120212-based treatment combination

Outcome Time Frame:

Duration of study (approximately 2.5 years)

Safety Issue:

Yes

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

European Union: European Medicines Agency

Study ID:

113486

NCT ID:

NCT01192165

Start Date:

September 2010

Completion Date:

July 2013

Related Keywords:

  • Cancer
  • Taxotere
  • Cisplatin
  • Carboplatin
  • Trametinib
  • GSK1120212
  • Tarceva
  • KRAS
  • Pemetrexed
  • MEK inhibitor
  • nab-Paclitaxel
  • Docetaxel
  • Alimta
  • Abraxane
  • Erlotinib

Name

Location

GSK Investigational Site Phoenix, Arizona  85013 - 4496
GSK Investigational Site Bakersfield, California  93309
GSK Investigational Site Fort Worth, Texas  76104
GSK Investigational Site Columbia, South Carolina  29210
GSK Investigational Site Germantown, Tennessee  38138
GSK Investigational Site Salem, Virginia  24153
GSK Investigational Site New York, New York  10021
GSK Investigational Site Aurora, Colorado  80012
GSK Investigational Site Henderson, Nevada  89014
GSK Investigational Site Seattle, Washington  98133