MK2206 and Erlotinib Hydrochloride in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Progressed After Previous Response to Erlotinib Hydrochloride Therapy

Part of paid clinical trials in Beverly Hills, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01294306
Phase
PHASE2
Status
Completed

Conditions

  • Adenosquamous Lung Carcinoma
  • Bronchioloalveolar Carcinoma
  • Large Cell Lung Carcinoma
  • Lung Adenocarcinoma
  • Recurrent Non-Small Cell Lung Carcinoma
  • Squamous Cell Lung Carcinoma

Eligibility Criteria

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

Interventions

  • Akt Inhibitor MK2206 — DRUG
    Given PO
  • Erlotinib Hydrochloride — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies

Study Details

This phase II trial studies the side effects and how well Akt inhibitor MK2206 (MK2206) and erlotinib hydrochloride works in treating patients with advanced non-small cell lung cancer who have progressed after previous response to erlotinib hydrochloride therapy. MK2206 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

First listed
Feb 11, 2011
Start date
Feb 28, 2011
Status verified
Oct 2016
Primary completion
Aug 31, 2015
Completion
Aug 31, 2015

Study Design

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

Arms

  • Experimental: Treatment (Akt inhibitor MK2206, erlotinib hydrochloride)
    Patients receive Akt inhibitor MK2206 PO QOD of a 28-day course, and erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Disease-control Rate [ Time Frame: At 12 weeks ]

Locations (7)

FacilityCityStateZIPSite coordinators
Tower Cancer Research FoundationBeverly HillsCalifornia90211-1850-
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
City of Hope South PasadenaSouth PasadenaCalifornia91030-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-

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