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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Locally Advanced, Metastatic Solid Tumors

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of dose-limiting toxicities (DLTs)

Outcome Time Frame:

Cycle 1 (One cycle = 21 days)

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

2009_547

NCT ID:

NCT00848718

Start Date:

March 2009

Completion Date:

May 2012

Related Keywords:

  • Locally Advanced, Metastatic Solid Tumors
  • Tumors, cancer
  • Neoplasms

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