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CompletedNCT01520389Updated Mar 21, 2018

Safety Study of the Drug MM-151 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment

A Phase 1 interventional study of MM-151 and MM-151 + irinotecan in Advanced Solid Tumors, Colorectal Cancer and Squamous Cell Head and Neck Cancer, sponsored by Merrimack Pharmaceuticals. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-21.

Sponsored by Merrimack Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
112
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study summary

This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-151 at varying dose levels and frequencies, and subsequently in combination with irinotecan.

Read the detailed description

This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design exploring weekly, bi-weekly, and tri-weekly dosing schedules. Successive MM-151 monotherapy cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified, and subsequently in combination with irinotecan. The study consists of three parts as follows: MM-151 monotherapy dose escalation (Part 1); MM-151 monotherapy expansion cohort in cetuximab-refractory colorectal cancer (Part 2); MM-151 + irinotecan dose escalation (Part 3). It is expected that approximately 4 study sites will participate.

02

Conditions studied

  • Advanced Solid Tumors
  • Colorectal Cancer
  • Squamous Cell Head and Neck Cancer
  • Non Small Cell Lung Cancer
  • Triple Negative Breast Cancer

Keywords

  • cancer
  • solid tumors
  • oncology
  • Phase I
  • EGFR
  • EGF receptor (ErbB1)
  • irinotecan
03

In context

Triple Negative Breast Neoplasms

1,140 studies on the registry are indexed under Triple Negative Breast Neoplasms; 443 are open to participants now.

This study's enrollment of 112 is above the median of 61 across 982 interventional studies indexed under Triple Negative Breast Neoplasms.

Browse Triple Negative Breast Neoplasms studies →

Lead sponsor

Merrimack Pharmaceuticals is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients must have histologically or cytologically confirmed advanced malignant solid tumor that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy, or who are not candidates for standard therapy
  • Patients must be > 18 years of age
  • Patients of their legal representatives must be able to understand and sign an informed consent form
  • Patients must have evaluable or measurable tumor(s)
  • Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy. Up to CTCAE Grade 1 is acceptable for patients with known peripheral neuropathy
  • Women of childbearing potential as well as fertile men and their partners must agree to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-151 (an effective form of contraception is an oral contraceptive or a double barrier method)

Exclusion criteria

Exclusion Criteria:

  • Patients for whom potentially curative antineoplastic therapy is available
  • Patients who are pregnant or lactating
  • Patients with an active infection or with an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing. (At the discretion of the investigator, patients with tumor fever may be enrolled.)
  • Patients with untreated and/or symptomatic CNS malignancies (primary or metastatic); patients with CNS metastases who have undergone surgery or radiotherapy, whose disease is stable, and who have been on a stable dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
112 participants (actual)

Study arms

  • Experimental
    MM-151 Dose Escalation

    MM-151 Dose escalation frequency - once weekly, once every two weeks, once every three weeks

    Drug: MM-151

  • Experimental
    MM-151 Expansion in KRAS wild type colorectal cancer

    MM-151 given weekly

    Drug: MM-151

  • Experimental
    MM-151 + irinotecan

    MM-151 given weekly, irinotecan 180 mg/m2 given once every two weeks

    Drug: MM-151 + irinotecan

Interventions

  • DrugMM-151

    MM-151

  • DrugMM-151 + irinotecan

    MM-151 + irinotecan

    Also known as: camptosar

06

What researchers measure

Primary outcomes

  1. Phase II dose of MM-151 alone and in combination with irinotecan based either on the maximum tolerated dose (MTD) or maximum dose of 18 mg/kg in patients with advanced solid malignancies.

    Time frame: Two years

Secondary outcomes

  1. Number of dose limiting toxicities (DLTs) within a cohort

    Time frame: 2 years

  2. Adverse event profile of MM-151 alone and in combination with irinotecan

    Time frame: 2 years

  3. Objective response to MM-151 alone and in combination with irinotecan based on RECIST

    Time frame: 2 years

07

Study locations

4 sites
  • University of Colorado Denver
    Aurora, Colorado 80045, United States
  • Horizon Oncology Research, Inc.
    Lafayette, Indiana 47905, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
  • South Texas Accelerated Research Therapeutics, LLC (START)
    San Antonio, Texas 78229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01520389
Lead sponsor
Merrimack Pharmaceuticals
Responsible party
Sponsor
First posted
Jan 30, 2012
Start date
Jan 2012
Primary completion
Dec 2015
Completion
Jan 2016
Last update
Mar 21, 2018
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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