Lapatinib With Sirolimus or Metformin

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01087983
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancers

Eligibility Criteria

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

Interventions

  • Lapatinib — DRUG
    Starting oral dose of 500 mg daily for 21 day cycle.
  • Sirolimus — DRUG
    Starting oral dose 1 mg daily.
  • Metformin — DRUG
    Starting oral dose 1000 mg daily.

Study Details

The goal of this clinical research study is to find the highest tolerable dose of 2 different combinations of drugs that can be given to patients with advanced cancer. The first combination of drugs is Tykerb (lapatinib) and Rapamune (sirolimus), and the second combination is lapatinib and Glucophage (metformin). The safety of these drug combinations will also be studied.

Key Dates

Start date
Mar 31, 2010
Status verified
Nov 2015
Primary completion
Sep 30, 2015
Completion
Sep 30, 2015

Study Design

Enrollment
111 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lapatinib + Sirolimus
    Lapatinib starting oral dose of 500 mg daily for 21 day cycle. Sirolimus starting oral dose 1 mg daily.
  • Experimental: Lapatinib + Metformin
    Lapatinib starting oral dose of 500 mg daily for 21 day cycle. Metformin Starting oral dose 1000 mg daily.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Lapatinib in Combination with Sirolimus or Metformin [ Time Frame: 21 day cycle ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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