A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00994123
• Other study ID #: MM-121-01-101 (ARD11585)
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: October 13, 2009
• Last updated: September 15, 2014
• Start date: February 2010
• Est. completion date: December 2014

Study information

• Verified date: September 2014
• Source: Merrimack Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: December 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• MM-121 (SAR256212) + erlotinib
MM-121 (SAR256212) = intravenous solution erlotinib = daily oral tablet
• Erlotinib
erlotinib = daily oral tablet

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merrimack Pharmaceuticals	Sanofi

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Korea, Republic of,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		June 2011	Yes
Secondary	Phase 2: To estimate the progression-free survival of the MM-121 + erlotinib combination in patients with NSCLC.		December 2012	No