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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00734305
First received: August 12, 2008
Last updated: November 20, 2013
Last verified: November 2013
  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 1

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:


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 ]

Enrollment: 44
Study Start Date: July 2008
Study Completion Date: September 2013
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
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 ClinicalTrials.gov identifier: NCT00734305

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115-6084
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
The Vanderbilt-Ingram Cancer Center
Nashville,, Tennessee, United States, 37232
Sponsors and Collaborators
Merrimack Pharmaceuticals
Sanofi
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: 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: November 20, 2013
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 September 18, 2014