A Combination Therapy Study of MK2206 and AZD6244 in Participants With Advanced Solid Tumors (MK-2206-010 AM5)



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:November 2009
End Date:May 2013
Contact:Toll Free Number
Phone:1-888-577-8839

Use our guide to learn which trials are right for you!

A Phase I Study of Oral MK2206 in Combination With Oral AZD6244 in Patients With Locally Advanced or Metastatic Solid Tumors


This study will investigate the safety and tolerability of combination therapy with MK2206
and AZD6244 and determine the maximum tolerated dose (MTD) and recommended Phase 2 dose
(RPTD) for this drug combination in the treatment of participants with locally advanced or
metastatic solid tumors. Preliminary efficacy data will also be collected.


Inclusion Criteria:

- Participant has confirmed metastatic or locally advanced solid tumor that has failed
to respond to standard therapy, progressed despite standard therapy, or therapies
known to provide clinical benefit, or for whom efficacious standard therapy or any
other therapy known to provide clinical benefit does not exist

- Participant has no history of prior cancer, except certain cervical, skin, or
prostate cancers, or has undergone potentially curative therapy with no evidence of
disease for 5 years

- At least 18 years of age

- Participant is able to swallow oral medications

- For participants enrolled in the MTD expansion cohorts, must have a diagnosis of
Kirsten rat sarcoma viral oncogene homolog (KRAS) tumor-type non small-cell lung
cancer (NSCLC). Additional tumor types (with specific mutations) may be added to the
MTD expansion cohorts after discussion between Sponsor and Investigator

Exclusion Criteria:

- Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks
of entering the study

- Participant is currently participating in or has participated in a study of an
investigational compound or device within 30 days or 5x the compound's half-life of
Cycle 1, Day 1

- Participant has known central nervous system metastases and/or carcinomatous
meningitis

- Participant has a primary central nervous system tumor or spinal cord compression

- Participant is, at the time of signing informed consent, a regular user (including
"recreational use") of any illicit drugs or had a recent history (within the last
year) of drug or alcohol abuse

- Participant is pregnant or breastfeeding or expecting to conceive or father children
within the projected duration of the study

- Participant is human immunodeficiency virus (HIV) positive

- Participant is has history of hepatitis B or C or active hepatitis A

- Participant has a history or current evidence of heart disease

- Participant has uncontrolled high blood pressure

- Participant has poorly controlled diabetes
We found this trial at
3
sites
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19111
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials