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A Phase I Study of MK2206 in Combination With Standard Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (2206-003 AM5)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00848718
First received: February 19, 2009
Last updated: January 21, 2015
Last verified: January 2015
History of Changes
February 19, 2009
January 21, 2015
March 2009
May 2011   (Final data collection date for primary outcome measure)
  • Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Cycle 1 (One cycle = 21 days) ]
  • Maximum tolerated dose (MTD) of each of the three combinations [ Time Frame: Cycle 1 (One cycle = 21 days) ]
  • Maximum plasma concentration of MK-2206 (Cmax) [ Time Frame: Cycle 1 and Cycle 2 (One cycle = 21 days) ]
  • Time to maximum plasma concentration of MK-2206 (Tmax) [ Time Frame: Cycle 1 and Cycle 2 (One cycle = 21 days) ]
  • Minimum plasma concentration of MK-2206 (Ctrough) [ Time Frame: Cycle 1 and Cycle 2 (One cycle = 21 days) ]
  • Area under the MK-2206 concentration versus time curve (AUC) [ Time Frame: Cycle 1 and Cycle 2 (One cycle = 21 days) ]
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 ]
Complete list of historical versions of study NCT00848718 on ClinicalTrials.gov Archive Site
Number of participants who had a tumor response, according to standard RECIST (Response Evaluation Criteria in Solid Tumors) criteria [ Time Frame: Tumor assessments will be performed at baseline and on Day 1 of every other cycle of treatment (every 6 weeks) ]
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 ]
Not Provided
Not Provided
 
A Phase I Study of MK2206 in Combination With Standard Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (2206-003 AM5)
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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Locally Advanced, Metastatic Solid Tumors
  • Drug: MK-2206 combined with carboplatin + paclitaxel
    MK-2206 given by mouth on days 1, 3, 5, and 7 of the 21 day cycle (30 mg, 45 mg, or 60 mg) OR MK-2206 given by mouth on Day 1 of the 21 day cycle (60 mg, 90 mg, 135 mg, 200 mg , or 250 mg). On Day 1 of each 21 Day cycle, carboplatin + paclitaxel is given intravenously.
    Other Name: Paraplatin, Taxol
  • Drug: MK-2206 combined with docetaxel
    MK-2206 given by mouth on days 1, 3, 5, and 7 of the 21 day cycle (either 45 mg or 60 mg) (this dosing schedule is no longer enrolling). MK-2206 given by mouth on Day 1 of the 21 day cycle (60 mg, 90 mg, 135 mg, 200 mg , or 250 mg). On day 1 of each 21 day cycle, docetaxel is given intravenously. In this treatment arm, an oral corticosteroid is to be taken by mouth every day.
    Other Name: Taxotere
  • Drug: MK-2206 combined with erlotinib
    MK-2206 given by mouth every other day (30 mg, 45 mg or 60 mg) OR MK-2206 given by mouth on Days 1, 8, and 15 of the 21 day cycle (90 mg, 135 mg, or 200 mg). In addition, erlotinib is given daily by mouth in a continuous 21 day cycle for the duration of the study.
    Other Name: Tarceva
  • Experimental: MK-2206 + carboplatin + paclitaxel
    MK-2206 combined with carboplatin and paclitaxel
    Intervention: Drug: MK-2206 combined with carboplatin + paclitaxel
  • Experimental: MK-2206 + docetaxel
    MK-2206 combined with docetaxel
    Intervention: Drug: MK-2206 combined with docetaxel
  • Experimental: MK-2206 + erlotinib
    MK-2206 combined with erlotinib
    Intervention: Drug: MK-2206 combined with erlotinib
Molife LR, Yan L, Vitfell-Rasmussen J, Zernhelt AM, Sullivan DM, Cassier PA, Chen E, Biondo A, Tetteh E, Siu LL, Patnaik A, Papadopoulos KP, de Bono JS, Tolcher AW, Minton S. Phase 1 trial of the oral AKT inhibitor MK-2206 plus carboplatin/paclitaxel, docetaxel, or erlotinib in patients with advanced solid tumors. J Hematol Oncol. 2014 Jan 3;7:1. doi: 10.1186/1756-8722-7-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
May 2012
May 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United Kingdom,   United States
 
NCT00848718
2206-003
2009_547
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP