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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MM-121
Erlotinib
Sponsored by
Merrimack Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Phase 1: Dose-Escalation

Phase 2: Control

Phase 2: Treatment

Arm Description

Escalating doses of MM-121 (QOW IV) and erlotinib (daily PO)

Erlotinib (daily)

MM-121 (QOW IV) and erlotinib (daily PO)

Outcomes

Primary Outcome Measures

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.
To establish the safety of escalating doses of MM-121 in combination with erlotinib in order to determine the recommended phase 2 dose of the combination for the second part of the study. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.
Phase 1: Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities
Using a 3+3 dose escalation model, the maximum tolerated dose was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in the expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was used as the recommended Phase 2 dose.
Phase 2: Progression-free Survival of the MM-121 + Erlotinib Combination
This was a time-to-event measure using Progression-Free Survival (PFS) comparing MM-121 + erlotinib vs.erlotinib alone. Progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of weeks from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).

Secondary Outcome Measures

Full Information

First Posted
October 13, 2009
Last Updated
July 12, 2016
Sponsor
Merrimack Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00994123
Brief Title
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

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merrimack Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1: Dose-Escalation
Arm Type
Experimental
Arm Description
Escalating doses of MM-121 (QOW IV) and erlotinib (daily PO)
Arm Title
Phase 2: Control
Arm Type
Active Comparator
Arm Description
Erlotinib (daily)
Arm Title
Phase 2: Treatment
Arm Type
Experimental
Arm Description
MM-121 (QOW IV) and erlotinib (daily PO)
Intervention Type
Drug
Intervention Name(s)
MM-121
Other Intervention Name(s)
SAR256212
Intervention Description
MM-121 (SAR256212) = intravenous solution
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
erlotinib = daily oral tablet
Primary Outcome Measure Information:
Title
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.
Description
To establish the safety of escalating doses of MM-121 in combination with erlotinib in order to determine the recommended phase 2 dose of the combination for the second part of the study. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.
Time Frame
From date of first dose to 30 days after termination, the longest 175 weeks
Title
Phase 1: Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities
Description
Using a 3+3 dose escalation model, the maximum tolerated dose was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in the expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was used as the recommended Phase 2 dose.
Time Frame
From date of first dose to 30 days after termination, the longest 175 weeks
Title
Phase 2: Progression-free Survival of the MM-121 + Erlotinib Combination
Description
This was a time-to-event measure using Progression-Free Survival (PFS) comparing MM-121 + erlotinib vs.erlotinib alone. Progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of weeks from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).
Time Frame
Time from first dose to date of progression, with a median of 8.1 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Moyo, MD
Organizational Affiliation
Merrimack Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
City
Edmonton
State/Province
Alberta
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Heidelberg
State/Province
Mannheim
ZIP/Postal Code
68167
Country
Germany
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
City
Lungenklinik
Country
Germany
City
Ulm
ZIP/Postal Code
89081
Country
Germany
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
135-710
Country
Korea, Republic of
City
Seoul
State/Province
Seodaemun-gu
ZIP/Postal Code
120-752
Country
Korea, Republic of
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Madrid
Country
Spain
City
Malaga
ZIP/Postal Code
29010
Country
Spain
City
Guishan
State/Province
Taoyuan County
ZIP/Postal Code
33305
Country
Taiwan
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
City
Taichung
Country
Taiwan
City
Tainan City
ZIP/Postal Code
70146
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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