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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Amgen

Information provided by (Responsible Party):

Ahmad Tarhini, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT01233687

First received: November 2, 2010

Last updated: July 20, 2016

Last verified: July 2016

History of Changes

Results First Received: January 12, 2016

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Carcinoma, Non-Small-Cell Lung
Intervention:	Drug: AMG 102 and erlotinib

Participant Flow

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Recruitment Details

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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
AMG 102 + Erlotinib	No text entered.

Participant Flow for 2 periods

Period 1: Phase I RP2D AMG 102 + Erlotinib

	AMG 102 + Erlotinib
STARTED	7
COMPLETED	7
NOT COMPLETED	0

Period 2: Phase II AMG 102 + Erlotinib

	AMG 102 + Erlotinib
STARTED	49 ^[1]
Response-Evaluable	45
COMPLETED	45
NOT COMPLETED	4
Death	1
Physician Decision	2
Withdrawal by Subject	1

[1]	Includes 7 participants from Phase 1 part of study.

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
AMG 102 + Erlotinib	No text entered.

Baseline Measures

	AMG 102 + Erlotinib
Number of Participants [units: participants]	45
Age [units: years] Median (Full Range)	65 (35 to 82)
Gender [units: participants]
Female	20
Male	25

Outcome Measures

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1. Primary:

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

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2. Primary:

Disease Control Rate (DCR) [ Time Frame: Six weeks from initiation of treatment with AMG 102 + Erlotinib ]

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3. Secondary:

Objective Response Rate (ORR/Clinical Response) [ Time Frame: Up to 6 months ]

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4. Secondary:

Progression-free Survival (PFS) [ Time Frame: Up to 24 months (after the first patient is accrued) ]

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5. Secondary:

Overall Survival (OS) [ Time Frame: Up to 24 months (after the first evaluable patient is accrued) ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Ahmad Tarhini, MD
Organization: University of Pittsburgh
phone: (412) 648-6578
e-mail: tarhiniaa@upmc.edu

Responsible Party:	Ahmad Tarhini, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT01233687 History of Changes
Other Study ID Numbers:	10-058
Study First Received:	November 2, 2010
Results First Received:	January 12, 2016
Last Updated:	July 20, 2016
Health Authority:	United States: Food and Drug Administration

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