A Phase I Study of MK-2206 in Combination With Standard Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (MK-2206-003)

• Status: Completed
• Trial end date: 2012-05-17
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the safety and tolerability of several dose levels of MK-2206 in combination with chemotherapy and targeted therapy agents in participants with locally advanced or metastatic solid tumors.

The primary hypotheses are that administration of MK-2206 in combination with either carboplatin + paclitaxel, docetaxel, or erlotinib in participants with locally advanced or metastatic solid tumors will have acceptable tolerability, a dose limiting toxicity (DLT) rate of ≤30%, plasma exposure and pharmacodynamics that exceed target thresholds, and allow for definition of a maximum tolerated dose (MTD) in each of the 3 combinations.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Docetaxel; Erlotinib Hydrochloride; Paclitaxel

Criteria

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.

Exclusion Criteria:

• 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 carcinomatous meningitis.

• 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.