AMG 102 and Erlotinib for Advanced Non-Small Cell Lung Cancer

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Ahmad Tarhini
Study ID
NCT01233687
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • AMG 102 and erlotinib — DRUG
    Dose Level -2 Dose level -1 Dose Level 0 AMG 102 5 mg/kg 7.5 mg/kg 15 mg/kg Erlotinib 150 mg 150 mg 150 mg The first cohort of patients in the phase I portion will start at dose level 0 of AMG102.

Study Details

This is a phase I/II study of erlotinib and AMG 102 in previously treated subjects with advanced NSCLC. Subjects will be enrolled with recurrent or progressive advanced stage NSCLC that has been treated with at least one and a maximum of two prior chemotherapy regimens. The Phase I part of the study will enroll 8-16 subjects with the Phase II part enrolling 21-45 subjects. The Phase I part of the study is designed to determine how safest the combination of AMG 102 and erlotinib is and the recommended dose for the Phase II part. The Phase II part is to determine whether the combination of AMG102 and erlotinib works enough to warrant further interest in this combination.

Key Dates

First listed
Nov 3, 2010
Start date
Aug 31, 2011
Status verified
May 2017
Primary completion
Nov 30, 2014
Completion
Nov 30, 2014

Study Design

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

Arms

  • Experimental: AMG 102 and erlotinib
    Combination of AMG 102 and erlotinib

Primary Outcome Measure

Percentage of Participants That Experienced a Dose Limiting Toxicity [ Time Frame: During first cycle of treatment (3 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Cancer InstitutePittsburghPennsylvania15232-

Find similar trials in Pittsburgh, PA

By research site
University of Pittsburgh Cancer Institute· Pittsburgh, PA

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