Clinical trial NCT01451632: A Safety Study of MM-121 With Cetuximab and Irinotecan in Patients With Advanced Cancers
Official title: A Phase 1 Study of MM-121 in Combination With Cetuximab and Irinotecan in Patients With Advanced Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colorectal Cancer
Squamous Cell Head and Neck Cancer
Non-small Cell Lung Cancer
Triple Negative Breast Cancer
Other Tumors With EGFR Dependence
Keywords: Metastatic Colorectal cancer
Kras wild-type
Squamous cell head and neck cancer
Non-small cell lung cancer
Triple negative breast cancer
EGFR
ErbB3
MM-121
Cetuximab
Irinotecan
Lead sponsor: Merrimack Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2011-10-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the safety and tolerability of escalating doses of the MM-121 plus cetuximab and the MM-121 plus cetuximab plus irinotecan combination.

Detailed description: This study was a Phase 1 and pharmacologic dose-escalation trial of MM-121 plus cetuximab plus irinotecan. The study assessed the safety, tolerability, and pharmacokinetics of MM-121, cetuximab and irinotecan.

Eligibility criteria: Inclusion Criteria:

* No standard options remaining
* Adequate liver and kidney functions
* 18 years of age or above

Exclusion Criteria:

* History of any secondary active cancer in the last 3 years.
* Pregnant or breast feeding
* History of severe allergic reactions or contraindications to cetuximab or irinotecan

Primary outcomes:
measure: Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Cetuximab and the MM-121 Plus Cetuximab Plus Irinotecan Combination
timeFrame: From date of first dose to 30 days after termination, the longest 48.1 weeks
measure: To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s) (Via Recording of Maximum Tolerated Dose (MTD)): MM-121 Doses
timeFrame: From date of first dose to 30 days after termination, the longest 48.1 weeks
measure: To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s): Cetuximab and Irinotecan
timeFrame: From date of first dose to 30 days after termination, the longest 48.1 weeks
Secondary outcomes:
measure: Objective Response Rate
timeFrame: Patients were assessed for objective response from time of first dose through treatment termination, the longest treatment duration being 48.1 weeks
measure: Pharmacokinetics
timeFrame: Collections taken for all patients at Cycle 1, Week 1 at pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121
measure: Pharmacokinetic Parameters of MM-121
timeFrame: Collections taken for all patients at Cycle 1, Week 1 at pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121
measure: Immunogenicity
timeFrame: Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 48.1 weeks, and a collection was made post-infusion in any case of infusion reaction
Other outcomes:
Locations:
city: San Francisco
country: United States
state: California
city: Boston
country: United States
state: Massachusetts
city: Chapel Hill
country: United States
state: North Carolina
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Merrimack Pharmaceuticals
name: Victor Moyo, MD
role: STUDY_DIRECTOR
References: