A Phase I Dose Escalation Study of MK-2206 in Combination With Standard Doses of Selected Chemotherapies or Targeted Agents in Patients With Locally Advanced or Metastatic Solid Tumors
Inclusion Criteria :
- Participants must have locally advanced or metastatic solid tumors.
- Participant is male or female greater than or equal to 18 years of age.
- Participant must have a performance status less than or equal to 1 on the Eastern
Cooperative Oncology Group (ECOG) Performance Scale
- Female participants of childbearing potential has a negative serum or urine pregnancy
test within 72 hours prior to receiving the first dose of study medication.
- Participants in the MK-2206 + carboplatin/paclitaxel and MK-2206 + docetaxel
treatment arms will be limited to no more than 3 prior cytotoxic therapies for
metastatic or recurrent diseases.
- Participant is able to swallow capsules and has no surgical or anatomical condition
that will prevent the Participant from swallowing.
- Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks.
- Participants must be least 4 weeks post-surgery and do not expect major surgery in
the study duration.
- Participant is currently participating or has participated in a study with an
investigational compound or device within 30 days.
- Participant has known active central nervous system (CNS) metastases and/or
- Participant with a primary central nervous system tumor.
- Participant has known hypersensitivity to the components of study drug.
- Participant has a history or current evidence of heart disease.
- Participant has evidence of clinically significant bradycardia (slow heart rate).
- Participant has uncontrolled high blood pressure.
- Participant at significant risk for hypokalemia (low potassium levels).
- Participant is a known diabetic
- Participant has known psychiatric or substance abuse disorders.
- Participant is a user of illicit drugs.
- Participant is pregnant or breastfeeding.
- Participant is Human Immunodeficiency Virus (HIV) positive.
- Participant has known history of Hepatitis B or C or active Hepatitis A.
- Participant has symptomatic ascites or pleural effusion.
- Participant is receiving treatment with oral corticosteroids.
- Participant is using a potent cytochrome P(450) 3A4 (CYP3A4) inhibitor or inducer.