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

Purpose

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.

Condition	Intervention	Phase
Advanced Solid Tumors	Drug: MM-151	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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:

Phase II dose 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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Objective response to MM-151 based on RECIST [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	63
Study Start Date:	January 2012
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MM-151 Weekly Dosing Dose escalation frequency - once weekly	Drug: MM-151 MM-151
Experimental: MM-151 Every Other Week Dosing Dose escalation frequency - every other week	Drug: MM-151 MM-151
Experimental: MM-151 Every Three Week Dosing Dose escalation frequency - every three weeks	Drug: MM-151 MM-151

Detailed Description:

This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified. The study will explore a weekly dosing schedule, an every other week dosing schedule and an every three week dosing schedule. An Expansion Cohort will be enrolled following demonstration of safety and adequate MM-151 concentration levels in the dose escalation phase. The expansion cohort will further characterize safety, pharmacokinetics and explore pharmacodynamic endpoints. It is expected that approximately 4 study sites will participate.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520389

Locations

United States, Colorado
University of Colorado Denver	Recruiting
Aurora, Colorado, United States, 80045
Contact: Chris Lieu, MD 303-724-6390 christopher.lieu@ucdenver.edu
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 wharb1@iuhealth.org
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 alex.adjei@roswellpark.org
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 murali.beeram@stoh.com
Principal Investigator: Muralidhar Beeram, MD

Sponsors and Collaborators

Merrimack Pharmaceuticals

More Information

No publications provided

Responsible Party:	Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01520389 History of Changes
Other Study ID Numbers:	MM-151-01-01-01
Study First Received:	January 13, 2012
Last Updated:	May 1, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merrimack Pharmaceuticals:

cancer
solid tumors
oncology

Phase I
EGFR
EGF receptor (ErbB1)

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013