Lapatinib Ditosylate and Akt Inhibitor MK2206 in Treating Women With Metastatic Breast Cancer

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01281163
Phase
PHASE1
Status
Terminated

Conditions

  • Estrogen Receptor Negative
  • Estrogen Receptor Positive
  • HER2/Neu Positive
  • Progesterone Receptor Negative
  • Progesterone Receptor Positive
  • Recurrent Breast Carcinoma
  • Stage IV Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Akt Inhibitor MK2206 — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Lapatinib Ditosylate — DRUG
    Given PO
  • Pharmacogenomic Study — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies

Study Details

This phase I trial studies the side effects and the best dose of lapatinib ditosylate and Akt inhibitor MK2206 in treating women with metastatic breast cancer. Lapatinib ditosylate and Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Jan 31, 2011
Status verified
Apr 2015
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Akt inhibitor MK2206 and lapatinib ditosylate)
    Patients receive lapatinib ditosylate PO QD on days 1 and 15-28 of course 1 and on days 1-28 of subsequent courses. Patients also receive AKT inhibitor MK2206 PO QD on days 8, 15, and 22 of course 1 and on days 1, 8, 15, and 22 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

MTD based on the dose-limiting toxicity, occurrence of adverse events and the associated NCI CTCAE grade of continuous daily administration of lapatinib ditosylate in combination with weekly administration of MK-2206 [ Time Frame: 28 days ]

Locations (5)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06520-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-

Find similar trials in New Haven, CT

By research site
Yale University· New Haven, CTDana-Farber Cancer Institute· Boston, MAUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MIWayne State University/Karmanos Cancer Institute· Detroit, MIVanderbilt University/Ingram Cancer Center· Nashville, TN

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