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

Carcinoma, Non-small Cell Lung Clinical Trial

Official title:

A Phase 1b, Multicenter Trial to Evaluate Molecular Determinants of Response to Erlotinib and MK0646 in Advanced Non-Small-Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729742
• Other study ID #: 0646-008
• Secondary ID: 2008_518CTRI/200
• Status: Completed
• Phase: Phase 1
• First received: August 4, 2008
• Last updated: April 1, 2016
• Start date: February 2009
• Est. completion date: May 2011

Study information

• Verified date: April 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-small Cell Lung
• Carcinoma, Non-Small-Cell Lung

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validate imaging platform and molecular markers		FDG response at Weeks 1 and 3 following chemotherapy	No
Secondary	Progression-free survival, overall survival		3 months	No