Clinical trial NCT00994123: A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer
Official title: A Phase 1-2 Trial of MM-121 in Combination With Erlotinib in Three Groups of Patients With Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-Small Cell Lung Cancer
NSCLC
Advanced Non-Small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer
Lung Cancer
Erlotinib
Tarceva
MM-121
ErbB3
Her3
Epidermal Growth Factor Receptor
anti-ErbB3 human monoclonal antibody
ErbB3 antagonist
Lead sponsor: Merrimack Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-10-14
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung cancer (NSCLC).

Detailed description: Phase 1: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to evaluate the safety, tolerability and recommended Phase 2 dose of MM-121 in combination with standard therapy.

Phase 2: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to estimate the progression-free survival of the MM-121 + standard therapy.

Eligibility criteria: Inclusion Criteria:

* Patients with locally advanced or metastatic non-small cell lung cancer.
* Patients must be \>/= 18 years of age.
* Patients must have adequate Performance Status (PS) as measured by ECOG and adequate end organ function.

Exclusion Criteria:

* Patients with a recent history (within 5 years) of another malignancy.
* Patients who are pregnant or nursing.
* Patients with clinically significant heart failure.
* Patients with clinically significant eye or gastrointestinal abnormalities.

Primary outcomes:
measure: Phase 1: To Determine the Recommended Phase 2 Dose of the MM-121 + Erlotinib Combination Based Upon Either the Maximum Tolerated Dose (MTD) or the Maximum Feasible Dose of the Combination in Patients With NSCLC.
timeFrame: From date of first dose to 30 days after termination, the longest 175 weeks
measure: Phase 1: Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities
timeFrame: From date of first dose to 30 days after termination, the longest 175 weeks
measure: Phase 2: Progression-free Survival of the MM-121 + Erlotinib Combination
timeFrame: Time from first dose to date of progression, with a median of 8.1 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Loma Linda
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Lafayette
country: United States
state: Indiana
city: Boston
country: United States
state: Massachusetts
city: St. Louis
country: United States
state: Missouri
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Edmonton
country: Canada
state: Alberta
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Heidelberg
country: Germany
state: Mannheim
city: Bad Berka
country: Germany
city: Frankfurt
country: Germany
city: Heidelberg
country: Germany
city: Lungenklinik
country: Germany
city: Ulm
country: Germany
city: Seoul
country: Korea, Republic of
state: Gangnam-gu
city: Seoul
country: Korea, Republic of
state: Seodaemun-gu
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Guishan
country: Taiwan
state: Taoyuan County
city: Taichung
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan City
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Merrimack Pharmaceuticals
name: Victor Moyo, MD
role: STUDY_DIRECTOR
References: