Recruitment

Recruitment Status
Completed
Estimated Enrollment
150

Inclusion Criterias

Documented evidence of distant metastasis or locoregional recurrence per required assessments within 28 days prior to starting study therapy.
ECOG (Eastern Cooperative Oncology Group) Performance Score of 0 or 1.
Histologic or cytologic confirmation of non-small cell lung cancer (NSCLC)
...
Documented evidence of distant metastasis or locoregional recurrence per required assessments within 28 days prior to starting study therapy.
ECOG (Eastern Cooperative Oncology Group) Performance Score of 0 or 1.
Histologic or cytologic confirmation of non-small cell lung cancer (NSCLC)
≥ 18 years of age.
Molecular characterization of the tumor demonstrating a KRAS mutation by a CLIA-certified assay. Adequate archival tissue, tissue core biopsy specimen, or DNA samples must be available for central testing of INK4a/Arf and p53 if not previously performed by a CLIA certified lab.

Exclusion Criterias

Leptomeningeal metastasis.
Presence of an activating EGFR (epidermal growth factor receptor) mutation or ALK (anaplastic lymphoma kinase) translocation in the tumor.
History or evidence of cardiac risk
...
Leptomeningeal metastasis.
Presence of an activating EGFR (epidermal growth factor receptor) mutation or ALK (anaplastic lymphoma kinase) translocation in the tumor.
History or evidence of cardiac risk
Known impairment of gastrointestinal function that would alter drug absorption.
Symptomatic or untreated brain metastases or spinal cord compression or any of these conditions requiring chronic steroids to control symptoms.
Radiotherapy (RT) completed within 14 days prior to the first dose of study therapy.
Another active concurrent malignancy.
Known history of malignant hypertension (severe hypertension >180/120 mmHg with end organ involvement.

Summary

Conditions
  • Lung Cancer
  • Non Small Cell Lung Cancer
Type
Interventional
Phase
Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Eleven subjects will be enrolled into one of four cohorts: Cohort A (KRAS mutation, wild type INK4a/ARF and wildtype p53), Cohort B (KRAS mutation, INK4s/ARF mutation and wild type p53), Cohort C (KRAS mutation, wild type INK4a/ARF and p53 mutation), and Cohort D (KRAS mutation, INK4a/ARF mutation a...

Eleven subjects will be enrolled into one of four cohorts: Cohort A (KRAS mutation, wild type INK4a/ARF and wildtype p53), Cohort B (KRAS mutation, INK4s/ARF mutation and wild type p53), Cohort C (KRAS mutation, wild type INK4a/ARF and p53 mutation), and Cohort D (KRAS mutation, INK4a/ARF mutation and p53 mutation). If >/= 4 patients demonstrate PFS at 12 weeks in each cohort, an additional 23 subjects will be enrolled.

Inclusion Criterias

Documented evidence of distant metastasis or locoregional recurrence per required assessments within 28 days prior to starting study therapy.
ECOG (Eastern Cooperative Oncology Group) Performance Score of 0 or 1.
Histologic or cytologic confirmation of non-small cell lung cancer (NSCLC)
...
Documented evidence of distant metastasis or locoregional recurrence per required assessments within 28 days prior to starting study therapy.
ECOG (Eastern Cooperative Oncology Group) Performance Score of 0 or 1.
Histologic or cytologic confirmation of non-small cell lung cancer (NSCLC)
≥ 18 years of age.
Molecular characterization of the tumor demonstrating a KRAS mutation by a CLIA-certified assay. Adequate archival tissue, tissue core biopsy specimen, or DNA samples must be available for central testing of INK4a/Arf and p53 if not previously performed by a CLIA certified lab.

Exclusion Criterias

Leptomeningeal metastasis.
Presence of an activating EGFR (epidermal growth factor receptor) mutation or ALK (anaplastic lymphoma kinase) translocation in the tumor.
History or evidence of cardiac risk
...
Leptomeningeal metastasis.
Presence of an activating EGFR (epidermal growth factor receptor) mutation or ALK (anaplastic lymphoma kinase) translocation in the tumor.
History or evidence of cardiac risk
Known impairment of gastrointestinal function that would alter drug absorption.
Symptomatic or untreated brain metastases or spinal cord compression or any of these conditions requiring chronic steroids to control symptoms.
Radiotherapy (RT) completed within 14 days prior to the first dose of study therapy.
Another active concurrent malignancy.
Known history of malignant hypertension (severe hypertension >180/120 mmHg with end organ involvement.

Locations

Dallas, Texas, 75390-8852
St. Louis, Missouri, 63110
Nashville, Tennessee, 37203
San Antonio, Texas, 78229-3900
Atlanta, Georgia, 30322
...
Dallas, Texas, 75390-8852
St. Louis, Missouri, 63110
Nashville, Tennessee, 37203
San Antonio, Texas, 78229-3900
Atlanta, Georgia, 30322
Baltimore, Maryland, 21287
Portland, Oregon, 97239
Denver, Colorado, 80045
Pittsburgh, Pennsylvania, 15232

Tracking Information

NCT #
NCT01951690
Collaborators
Not Provided
Investigators
  • Principal Investigator: David E Gerber, M.D. University of Texas Southwestern Medical Center
  • David E Gerber, M.D. University of Texas Southwestern Medical Center