A Safety Study of MM-121 With Cetuximab and Irinotecan in Patients With Advanced Cancers

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Cancer Squamous Cell Head and Neck Cancer Non-small Cell Lung Cancer Triple Negative Breast Cancer Other Tumors With EGFR Dependence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: MM-121 + cetuximab

increasing doses of weekly MM-121 + weekly cetuximab

Group Type EXPERIMENTAL

MM-121

Intervention Type DRUG

escalating doses MM-121 IV QW

Cetuximab

Intervention Type DRUG

escalating doses cetuximab IV QW

Part 2: MM-121 + cetuximab + irinotecan

increasing doses of irinotecan + the Recommended Phase 2 Dose/Maximum Tolerated Dose (RP2D/MTD) of MM121 + cetuximab as determined in Part 1

Group Type EXPERIMENTAL

MM-121

Intervention Type DRUG

escalating doses MM-121 IV QW

Irinotecan

Intervention Type DRUG

180 mg/m2 IV Q2W

Cetuximab

Intervention Type DRUG

escalating doses cetuximab IV QW

Interventions

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MM-121

escalating doses MM-121 IV QW

Intervention Type DRUG

Irinotecan

180 mg/m2 IV Q2W

Intervention Type DRUG

Cetuximab

escalating doses cetuximab IV QW

Intervention Type DRUG

Other Intervention Names

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Seribantumab, SAR256212 Camptosar Erbitux

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No