Comparison of Biomarker Modulation by Inhibition of EGFR and/or SRC Family

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT00779389
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Erlotinib — DRUG
    Erlotinib 150mg will be taken once a day for 14-21days.
  • Dasatinib + Placebo — DRUG
    Dasatinib (100 mg) once a day for 14-21 days.
  • Erlotinib plus Dasatinib — DRUG
    Erlotinib (150 mg PO qD) plus Dasatinib (100 mg PO qD) 14-21 days
  • Placebo — DRUG
    Placebo for 14-21 days.
  • Erlotinib — DRUG
    Erlotinib 150 mg for 14-21 days.

Study Details

The central hypothesis to be tested in this study is that dual blockade of EGFR and Src pathways or proteins are distinct compared to inhibition of either kinase alone in head and neck and lung cancers.

Key Dates

First listed
Oct 24, 2008
Start date
Jan 31, 2009
Status verified
Feb 2015
Primary completion
Feb 28, 2014
Completion
Feb 28, 2014

Study Design

Enrollment
58 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Erlotinib 150 mg
  • Experimental: Arm B
    Dasatinib + placebo
  • Experimental: Arm C
    Erlotinib (150 mg) plus Dasatinib (100 mg) for 14-21 days.
  • Placebo Comparator: Arm D
    Placebo for 14-21 days

Primary Outcome Measure

The primary endpoints are comprised of a panel of tumor proteins to be obtained before after administration of the study drugs. [ Time Frame: 2-3 week preoperative period of drug administration ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hillman Cancer CenterPittsburghPennsylvania15232-

Find similar trials in Pittsburgh, PA

By condition
Head and neck cancerLung cancer
By specialty
OncologyENTLung oncologyLung disease
By research site
Hillman Cancer Center· Pittsburgh, PA

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