A Combination Therapy Study of MK2206 and AZD6244 in Participants With Advanced Solid Tumors (MK-2206-010 AM6)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

AstraZeneca

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01021748

First received: November 25, 2009

Last updated: April 26, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	November 25, 2009
Last Updated Date	April 26, 2013
Start Date ^ICMJE	November 2009
Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 25, 2009)	Incidence of dose limiting toxicities (DLTs) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01021748 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 13, 2011)	Number of participants with a tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Baseline and after every 8 weeks of treatment until documentation of objective response or disease progression ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Combination Therapy Study of MK2206 and AZD6244 in Participants With Advanced Solid Tumors (MK-2206-010 AM6)
Official Title ^ICMJE	A Phase I Study of Oral MK2206 in Combination With Oral AZD6244 in Patients With Locally Advanced or Metastatic Solid Tumors
Brief Summary	This study will investigate the safety and tolerability of combination therapy with MK2206 and AZD6244 and determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RPTD) for this drug combination in the treatment of participants with locally advanced or metastatic solid tumors. Preliminary efficacy data will also be collected.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Locally Advanced or Metastatic Solid Tumors
Intervention ^ICMJE	Drug: MK2206 plus AZD6244 MK-2206 (tablets) orally, in a once every-other-day (starting dose 45 mg) or once-weekly (starting dose 90 mg) schedule, and AZD6244 (capsules), orally, twice a day (starting dose 75 mg). Doses will be escalated to the MTD.
Study Arm (s)	Experimental: MK-2206 + AZD6244 Intervention: Drug: MK2206 plus AZD6244
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	75
Estimated Completion Date	May 2013
Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Participant has confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or therapies known to provide clinical benefit, or for whom efficacious standard therapy or any other therapy known to provide clinical benefit does not exist Participant has no history of prior cancer, except certain cervical, skin, or prostate cancers, or has undergone potentially curative therapy with no evidence of disease for 5 years At least 18 years of age Participant is able to swallow oral medications For participants enrolled in the MTD expansion cohorts, must have a diagnosis of Kirsten rat sarcoma viral oncogene homolog (KRAS) tumor-type non small-cell lung cancer (NSCLC). Additional tumor types (with specific mutations) may be added to the MTD expansion cohorts after discussion between Sponsor and Investigator Exclusion Criteria: Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks of entering the study Participant is currently participating in or has participated in a study of an investigational compound or device within 30 days or 5x the compound's half-life of Cycle 1, Day 1 Participant has known central nervous system metastases and/or carcinomatous meningitis Participant has a primary central nervous system tumor or spinal cord compression Participant is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse Participant is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study Participant is human immunodeficiency virus (HIV) positive Participant is has history of hepatitis B or C or active hepatitis A Participant has a history or current evidence of heart disease Participant has uncontrolled high blood pressure Participant has poorly controlled diabetes
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01021748
Other Study ID Numbers ^ICMJE	2206-010, 2009_698
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	AstraZeneca
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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