Study of Erlotinib and Metformin in Triple Negative Breast Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT01650506
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin — DRUG
    Due to frequent GI upset in patients starting metformin the dose will be titrated up to the assigned dose level. The first metformin dose level will be 850 mg twice daily and be escalated to its maximum FDA approved dose of 850 mg three times daily. Dose escalation will follow the standard 3 + 3 design. Dose limiting toxicities will be determined during the first 5 weeks of therapy.
  • Erlotinib — DRUG
    Erlotinib dosing will start and remain at 150 mg daily.

Study Details

Extended phase 1 trial of combined metformin and erlotinib in advanced triple negative breast cancer patients. The goals of the study are to establish the maximum tolerated combined dosing of erlotinib and metformin as well as deciding if there is a potential clinical utility of the combination in treating patients with triple negative breast cancer.

Key Dates

First listed
Jul 26, 2012
Start date
Jul 31, 2012
Status verified
Aug 2017
Primary completion
Jun 30, 2016
Completion
Jun 30, 2016

Study Design

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

Arms

  • Experimental: Erlotinib + Metformin
    This is a single arm phase 1 study. All patients will receive erlotinib and metformin.

Primary Outcome Measure

The maximum tolerated dose of metformin in combination with a fixed dose of 150 mg erlotinib daily [ Time Frame: Up to 5 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia UniversityNew YorkNew York10032-

Find similar trials in New York, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Columbia University· New York, NY

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