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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00994123
First received: October 13, 2009
Last updated: July 12, 2016
Last verified: July 2016

October 13, 2009
July 12, 2016
February 2010
November 2014   (final data collection date for primary outcome 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. [ Time Frame: From date of first dose to 30 days after termination, the longest 175 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: From date of first dose to 30 days after termination, the longest 175 weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Time from first dose to date of progression, with a median of 8.1 weeks ] [ Designated as safety issue: No ]
    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).
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. [ Time Frame: December 2009 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00994123 on ClinicalTrials.gov Archive Site
Not Provided
Phase 2: To estimate the Non-Progression Rate of the MM-121 + erlotinib combination at >/= 24 weeks in patients with NSCLC. [ Time Frame: January 2011 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer
A Phase 1-2 Trial of MM-121 in Combination With Erlotinib in Three Groups of Patients With Non-Small Cell Lung Cancer
A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung cancer (NSCLC).

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • Drug: MM-121
    MM-121 (SAR256212) = intravenous solution
    Other Name: SAR256212
  • Drug: Erlotinib
    erlotinib = daily oral tablet
    Other Name: Tarceva
  • Experimental: Phase 1: Dose-Escalation
    Escalating doses of MM-121 (QOW IV) and erlotinib (daily PO)
    Interventions:
    • Drug: MM-121
    • Drug: Erlotinib
  • Active Comparator: Phase 2: Control
    Erlotinib (daily)
    Intervention: Drug: Erlotinib
  • Experimental: Phase 2: Treatment
    MM-121 (QOW IV) and erlotinib (daily PO)
    Interventions:
    • Drug: MM-121
    • Drug: Erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
June 2015
November 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany,   Korea, Republic of,   Spain,   Taiwan
 
NCT00994123
MM-121-01-101
No
Not Provided
Not Provided
Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Not Provided
Study Director: Victor Moyo, MD Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP