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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Merrimack Pharmaceuticals
Information provided by (Responsible Party):
Merrimack Pharmaceuticals Identifier:
First received: January 13, 2012
Last updated: January 27, 2014
Last verified: January 2014

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.

Condition Intervention Phase
Advanced Solid Tumors
Colorectal Cancer
Squamous Cell Head and Neck Cancer
Non Small Cell Lung Cancer
Triple Negative Breast Cancer
Drug: MM-151
Drug: MM-151 + irinotecan
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 and Pharmacologic Study of MM-151 in Patients With Refractory Advanced Solid Tumors

Resource links provided by NLM:

Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of dose limiting toxicities (DLTs) within a cohort [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Adverse event profile of MM-151 alone and in combination with irinotecan [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Objective response to MM-151 alone and in combination with irinotecan based on RECIST [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 115
Study Start Date: January 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
MM-151 + irinotecan
Other Name: camptosar

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01520389

United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Chris Lieu, MD    303-724-6390   
Principal Investigator: Chris Lieu, MD         
United States, Indiana
Horizon Oncology Research, Inc. Recruiting
Lafayette, Indiana, United States, 47905
Contact: Wael Harb, MD    765-446-5111   
Principal Investigator: Wael Harb, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Alex Adjei, MD    716-845-4101   
Principal Investigator: Alex Adjei, MD         
United States, Texas
South Texas Accelerated Research Therapeutics, LLC (START) Recruiting
San Antonio, Texas, United States, 78229
Contact: Muralidhar Beeram, MD    210-593-5250   
Principal Investigator: Muralidhar Beeram, MD         
Sponsors and Collaborators
Merrimack Pharmaceuticals
  More Information

No publications provided

Responsible Party: Merrimack Pharmaceuticals Identifier: NCT01520389     History of Changes
Other Study ID Numbers: MM-151-01-01-01
Study First Received: January 13, 2012
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merrimack Pharmaceuticals:
solid tumors
Phase I
EGF receptor (ErbB1)

Additional relevant MeSH terms:
Triple Negative Breast Neoplasms
Breast Diseases
Breast Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on March 26, 2015