Phase I Imaging Study Evaluating Dalotuzumab (MK0646) in Combination With Erlotinib for Patients With Non-Small Cell Lung Cancer (MK-0646-008)

NCT ID: NCT00729742

Last Updated: 2016-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2011-05-31

Brief Summary

This study will use imaging to look at tumor response to erlotinib (Part I) and the combination of erlotinib and dalotuzumab (Part II).

Conditions

Carcinoma, Non-small Cell Lung

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1

erlotinib

Group Type: EXPERIMENTAL

Comparator: erlotinib monotherapy

Intervention Type: DRUG

Part I: All patients will receive erlotinib 150 mg tablets per day until disease progression.

Part 2

erlotinib + dalotuzumab

Group Type: EXPERIMENTAL

Comparator: erlotinib + dalotuzumab

Intervention Type: DRUG

Part II: All patients will receive 1 week of erlotinib 150 mg tablets per day.

Arm 1: Patients who experience a PET response will continue on erlotinib monotherapy until disease progression.

Arm 2: Patients who fail to receive a PET response will continue to take erlotinib in combination with dalotuzumab 10 mg/kg IV infusion once weekly. At the time of disease progression, patients on erlotinib monotherapy will be offered to crossover to dalotuzumab 10 mg/kg IV infusion once weekly in combination with erlotinib.

Interventions

Comparator: erlotinib + dalotuzumab

Part II: All patients will receive 1 week of erlotinib 150 mg tablets per day.

Arm 1: Patients who experience a PET response will continue on erlotinib monotherapy until disease progression.

Arm 2: Patients who fail to receive a PET response will continue to take erlotinib in combination with dalotuzumab 10 mg/kg IV infusion once weekly. At the time of disease progression, patients on erlotinib monotherapy will be offered to crossover to dalotuzumab 10 mg/kg IV infusion once weekly in combination with erlotinib.

Intervention Type: DRUG

Comparator: erlotinib monotherapy

Part I: All patients will receive erlotinib 150 mg tablets per day until disease progression.

Intervention Type: DRUG

Other Intervention Names

TARCEVA®; TARCEVA®

Eligibility Criteria

Inclusion Criteria

• Patient has locally advanced or metastatic stage IIIB/IV Non-small cell lung cancer
• Patient has measurable disease
• Patient has accessible tumor and consents to undergo a tumor biopsy [Part II only]
• Patient is 18 years of age or older
• Patient has a performance status of 0-2 on ECOG scale
• Women of childbearing potential have a negative pregnancy test
• Patients in Part I must: 1. be a female non-smoker with non-squamous histology who has had one or two prior systemic chemotherapies or 2. have documented EGFR mutation or EGFR gene amplification, regardless of demographic or clinical characteristics, who have had no more than two prior systemic chemotherapies.
• Patients in Part II must have had one or two chemotherapy regimens for recurrent or metastatic disease

Exclusion Criteria

• Patient has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks
• Patient has not recovered from adverse events from previous therapy within 4 weeks
• Patient has received EGFR-TKI inhibitor/anti-EGFR mAb therapy
• Patient has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy
• Patient has untreated brain metastases
• Patient has had radiotherapy to a field that affects the chest or abdomen, or thoracic surgery within 3 months prior to entering the study
• Patient is taking part in another clinical study
• Patient abuses drugs or alcohol
• Patient is pregnant or breastfeeding
• Subject is HIV positive
• Patient has active hepatitis
• Patient is using growth hormone or growth hormone inhibitors
• Patient has poorly controlled diabetes mellitus

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2008_518

Identifier Type: -

Identifier Source: secondary_id

CTRI/2009/091/000139

Identifier Type: REGISTRY

Identifier Source: secondary_id

0646-008

Identifier Type: -

Identifier Source: org_study_id