Akt Inhibitor MK2206 in Combination With Lapatinib Ditosylate in Patients With Advanced or Metastatic Solid Tumors or Breast Cancer

Part of paid clinical trials in Sioux Falls, South Dakota.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01245205
Phase
PHASE1
Status
Completed

Conditions

  • HER2-positive Breast Cancer
  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

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

Interventions

  • Akt inhibitor MK2206 — DRUG
    Given PO
  • lapatinib ditosylate — DRUG
    Given PO
  • pharmacological study — OTHER
    Correlative studies
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This phase I trial studies the side effects and the best dose of Akt inhibitor MK2206 and lapatinib ditosylate in treating patients with solid tumors or breast cancer that has spread to other places in the body. Akt inhibitor MK2206 and lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Nov 30, 2010
Status verified
Oct 2014
Primary completion
Aug 31, 2014

Study Design

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

Arms

  • Experimental: Treatment (Akt inhibitor MK2206 and lapatinib ditosylate)
    Patients receive Akt inhibitor MK2206 PO QOD for 28 days (35 days for course 1) and lapatinib ditosylate PO QD or BID on days 1-28 (days 9-35 for course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

MTD of Akt inhibitor MK-2206 and lapatinib ditosylate, defined as the dose level at which less than one-third of patients experience a DLT as graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.4 (Part I) [ Time Frame: 35 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Sanford Cancer Center-Oncology ClinicSioux FallsSouth Dakota57104-
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-

Find similar trials in Sioux Falls, SD

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Sanford Cancer Center-Oncology Clinic· Sioux Falls, SDUniversity of Wisconsin Hospital and Clinics· Madison, WI

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