Randomized Phase II Study of AZD6244 (Mitogen-activated Protein Kinase Inhibitor) MEK-Inhibitor With Erlotinib in KRAS Wild Type Advanced Non-Small Cell Lung Cancer (NSCLC) and a Randomized Phase II Study of AZD6244 With Erlotinib in Mutant KRAS Adva...

Part of paid clinical trials in Davis, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01229150
Phase
PHASE2
Status
Completed

Conditions

  • Non Small Cell Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD6244 — DRUG
    For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day).
  • Erlotinib — DRUG
    For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd (every day)
  • AZD6244 + Erlotinib — DRUG
    For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erl (erlotinib) mg qd.

Study Details

Background: AZD6244 (ARRY-142886) is an investigational anticancer drug that is designed to block a critical component (MEK (methyl ethyl ketone)) of a pathway (MAP (mitogen-activated protein) kinase pathway) that causes some lung cancer cells to grow. The MAP kinase pathway could be overactive in a proportion of lung cancers, including some which also have another mutation in a protein known as KRAS (Kirsten rat sarcoma viral oncogene homolog). Approximately 20% of lung cancers have KRAS mutations which can make some cancer treatments including erlotinib, a standard anticancer treatment drug less effective. Researchers are interested in determining whether AZD6244 is effective in treating advanced NSCLC (non small cell lung cancer), including KRAS mutated lung cancer that has not responded to standard therapy. Objectives: To determine the effectiveness of AZD6244, either alone or in combination with erlotinib, in preventing tumor growth in individuals with NSCLC. Eligibility: Individuals at least 18 years of age who have been diagnosed with advanced NSCLC that has not responded to standard therapy. Design: * Participants will be screened with a medical history, physical examination, blood tests, imaging studies, and potentially, tumor biopsy tests to determine whether a participant's NSCLC contains mutations in the KRAS protein. * Participants will be divided into two groups based on the status of the KRAS protein in their NSCLC tumor cells: * Individuals with normal KRAS protein: Half will receive AZD6244 and erlotinib, and half will receive only erlotinib. * Individuals with mutated KRAS protein: Half will receive AZD6244 and erlotinib, and half will receive only AZD6244. * Participants will take their assigned medications daily (on an empty stomach in the morning and/or evening, depending on the treatment) for 28-day cycles of treatment. Participants will also keep a medication diary to record any side effects. * Participants will have frequent blood tests during the first cycle of treatment, and will have imaging studies or other tests as required by the study researchers. Participants may also have an additional tumor biopsy after the end of the first treatment cycle. * Treatment will continue until the disease progresses, significant side effects develop, the participant chooses to leave the study, or the researchers end the study....

Key Dates

First listed
Oct 27, 2010
Start date
Oct 26, 2010
Status verified
Apr 2017
Primary completion
Sep 30, 2013
Completion
Nov 21, 2015

Study Design

Enrollment
89 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: KRAS Mut 2
    KRAS Mutant patients randomized to combination therapy arm
  • Active Comparator: KRAS Mut 1
    KRAS Mutant patients randomized to monotherapy arm
  • Active Comparator: WT KRAS 1
    Wild-Type KRAS patients randomized to monotherapy arm
  • Active Comparator: WT KRAS 2
    Wild-Type KRAS patients randomized to combination therapy arm

Primary Outcome Measure

Progression Free Survival [ Time Frame: 2.1 to 4 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of California, DavisDavisCalifornia95616-
University of Southern California Health Sciences CampusLos AngelesCalifornia90033-
City of Hope Medical GroupSouth PasadenaCalifornia91030-
University of Chicago Medical CenterChicagoIllinois60637-
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMaryland20892-

Find similar trials in Davis, CA

By research site
University of California, Davis· Davis, CAUniversity of Southern California Health Sciences Campus· Los Angeles, CACity of Hope Medical Group· South Pasadena, CAUniversity of Chicago Medical Center· Chicago, ILNational Institutes of Health Clinical Center, 9000 Rockville Pike· Bethesda, MD

Related Studies