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

Phase 1
18 Years
Open (Enrolling)
Locally Advanced or Metastatic Solid Tumors

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Trial Information

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

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Incidence of dose limiting toxicities (DLTs)

Outcome Time Frame:

28 days

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

August 2013

Related Keywords:

  • Locally Advanced or Metastatic Solid Tumors
  • Neoplasms