Phase I Safety Study of the Drug MM-121 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment

This study is currently recruiting participants.

Verified January 2011 by Merrimack Pharmaceuticals

First Received on August 12, 2008. Last Updated on January 31, 2011 History of Changes

Sponsor:	Merrimack Pharmaceuticals
Information provided by:	Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00734305

Purpose

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 initially explore a dosing schedule every 7-days, which may be modified to longer intervals under certain circumstances. Once the maximum tolerated dose or recommended Phase 2 dose is identified, an Expansion Cohort will be enrolled at that dose to further characterize safety and to explore pharmacodynamic endpoints. It is anticipated 2-3 study sites will participate in this trial.

Condition	Intervention	Phase
Advanced Solid Tumors	Drug: MM-121	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I and Pharmocologic Study of MM-121 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:

To determine the Phase II dose based either on the maximum tolerated dose (MTD) or maximum dose of 20 mg/kg in patients with advanced solid malignancies. To describe any objective response to MM-121 based on RECIST [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To describe the dose limiting toxicity of MM-121 To determine the adverse event profile of MM-121 To determine the pharmacokinetic parameters of MM-121 To describe certian pharmacodynamic parameters of MM-121 [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2011
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: I	Drug: MM-121 Dose escalation Frequency - once weekly

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 solid tumors that have recurred or progressed following standard therapy, or that have 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-121 (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: NCT00734305

Locations

United States, Massachusetts
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115-6084
Contact: Kwok Kin Wong 617-632-6084 Kwok_Wong@dfci.harvard.edu
Principal Investigator: Kwok Kin Wong, M.D.
United States, Pennsylvania
Fox Chase Cancer Center	Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Crystal Denlinger 215-728-2689 Crystal.Denlinger@fccc.edu
Principal Investigator: Crystal Denlinger, MD
United States, Tennessee
The Vanderbilt-Ingram Cancer Center	Recruiting
Nashville,, Tennessee, United States, 37232
Contact: Vicky Keedy, MD 615-322-4967 vicki.keedy@vanderbilt.edu
Principal Investigator: Vicki Keedy, M.D

Sponsors and Collaborators

Merrimack Pharmaceuticals

Investigators

Principal Investigator:	Crystal Denlinger, MD	Fox Chase Cancer Center
Principal Investigator:	Kwok Kin Wong, MD	Dana-Farber Cancer Institute
Principal Investigator:	Keedy L Vicki, MD	Vanderbilt University

More Information

No publications provided

Responsible Party:	MM-121 Clinical Trial Manager, Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00734305 History of Changes
Other Study ID Numbers:	MM-121-01-100, MM-121
Study First Received:	August 12, 2008
Last Updated:	January 31, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merrimack Pharmaceuticals:

cancer, solid tumors, oncology, Phase I, ErbB3, HER3
(erbB-3, HER-3)

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012