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

August 12, 2008
November 20, 2013
July 2008
May 2010   (final data collection date for primary outcome measure)
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 ]
To determine the Phase II dose based either on the maximum tolerated dose (MTD) or maximum feasible dose in patients with advanced solid malignancies. To describe any objective response to MM-121 based on RECIST [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00734305 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Phase I Safety Study of the Drug MM-121 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment
A Phase I and Pharmocologic Study of MM-121 in Patients With Refractory Advanced Solid Tumors

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors
Drug: MM-121
Dose escalation Frequency - once weekly
Experimental: I
Intervention: Drug: MM-121
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
September 2013
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00734305
MM-121-01-100, MM-121
Yes
Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Sanofi
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
Merrimack Pharmaceuticals
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP