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A Phase I Study of MK2206 in Combination With Standard Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors
This study is currently recruiting participants.
Verified by Merck, August 2009
First Received: February 19, 2009   Last Updated: August 12, 2009   History of Changes
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00848718
  Purpose

The purpose of this study is to compare the safety and tolerability of two different dose levels of MK2206 in combination with chemotherapy and targeted therapy agents in patients with locally advanced or metastatic solid tumors.


Condition Intervention Phase
Locally Advanced, Metastatic Solid Tumors
Drug: MK2206 combined with carboplatin + paclitaxel
Drug: MK2206 combined with docetaxel.
Drug: MK2206 combined with Erlotinib
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title: A Phase I Dose Escalation Study of MK2206 in Combination With Standard Doses of Selected Chemotherapeutic or Targeted Agents in Patients With Locally Advanced or Metastatic Solid Tumors.

Resource links provided by NLM:


Further study details as provided by Merck:

Primary Outcome Measures:
  • To assess the safety, tolerability and side effects of MK2206 when given in combination with selected chemo and targeted agents in patients with locally advanced or metastatic solid tumors by monitoring of adverse events and clinical/lab measurements. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To explore the anti-tumor activity of MK2206 in combination with either carboplatin + paclitaxel, docetaxel or erlotinib in patients with advanced solid tumors as assessed by imaging and clinical and laboratory evaluations. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: March 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
MK2206 combined with Carboplatin + Paclitaxel.
Drug: MK2206 combined with carboplatin + paclitaxel
MK2206 given on days 1, 3, 5, and 7 of the 21 day cycle(either 45 mg or 60 mg). On day 1 of each 21 day cycle, Carboplatin + paclitaxel is given by vein.
2: Experimental
MK2206 combined with Docetaxel.
Drug: MK2206 combined with docetaxel.
MK2206 given on days 1, 3, 5, and 7 of the 21 day cycle (either 45 mg or 60 mg). On day 1 of each 21 day cycle, docetaxel is given by vein. In this treatment arm, an oral corticosteroid is to be taken by mouth every day.
3: Experimental
MK2206 combined with Erlotinib
Drug: MK2206 combined with Erlotinib
MK2206 given by mouth every other day (either 45 mg or 60 mg). In addition, Erlotinib is given daily by mouth in a continuous 21 day cycle for the duration of the study.

  Eligibility

Ages Eligible for Study:   18 Years to 91 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have locally advanced or metastatic solid tumors.
  • Patient is male or female greater than or equal to 18 years of age.
  • Female patients of childbearing potential has a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication
  • Patients will be limited to 2 prior cytoxic therapies for metastatic or recurrent diseases
  • Patient is able to swallow capsules and has no surgical or anatomical condition that will prevent the patient from swallowing

Exclusion Criteria:

  • Patient has had chemotherapy, radiotherapy or biological therapy with 4 weeks
  • Patients must be least 4 weeks post-surgery and do not expect major surgery in the study duration
  • Patient is currently participating or has participated in a study with an investigational compound or device within 30 days
  • Patient has known active CNS metastases and/or carcinomatous meningitis
  • Patient with a primary central nervous system tumor
  • Patient has known hypersensitivity to the components of study drug
  • Patient has a history or current evidence of heart disease
  • Patient has evidence of clinically significant bradycardia (slow heart rate)
  • Patient has uncontrolled high blood pressure
  • Patient at significant risk for hypokalemia (low potassium levels)
  • Patient is a known diabetic patient
  • Patient has known psychiatric or substance abuse disorders
  • Patient is a user of illicit drugs
  • Patient is pregnant or breastfeeding
  • Patient is HIV positive
  • Patient has known history of Hepatitis B or C or active Hepatitis A
  • Patient has symptomatic ascites or pleural effusion
  • Patient is receiving treatment with oral corticosteroids
  • Patient is using a potent CYPA4 inhibitor or inducer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848718

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United States, Florida
Call for Information Recruiting
Tampa, Florida, United States, 33612
United States, Texas
Call for Information Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2009_547, MK2206-003
Study First Received: February 19, 2009
Last Updated: August 12, 2009
ClinicalTrials.gov Identifier: NCT00848718     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Erlotinib
Docetaxel
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Carboplatin
Protein Kinase Inhibitors
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Erlotinib
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Enzyme Inhibitors
Carboplatin
Antimitotic Agents
Protein Kinase Inhibitors
Pharmacologic Actions
Docetaxel
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on August 30, 2009