Clinical Trials /

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

NCT01520389

Description:

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.

Related Conditions:
  • Colorectal Carcinoma
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety Study of the Drug MM-151 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment
  • Official Title: A Phase 1 and Pharmacologic Study of MM-151 in Patients With Refractory Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: MM-151-01-01-01
  • NCT ID: NCT01520389

Conditions

  • Advanced Solid Tumors
  • Colorectal Cancer
  • Squamous Cell Head and Neck Cancer
  • Non Small Cell Lung Cancer
  • Triple Negative Breast Cancer

Interventions

DrugSynonymsArms
MM-151MM-151 Dose Escalation
MM-151 + irinotecancamptosarMM-151 + irinotecan

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, and subsequently in combination with irinotecan.

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.
    

Trial Arms

NameTypeDescriptionInterventions
MM-151 Dose EscalationExperimentalMM-151 Dose escalation frequency - once weekly, once every two weeks, once every three weeks
  • MM-151
MM-151 Expansion in KRAS wild type colorectal cancerExperimentalMM-151 given weekly
  • MM-151
MM-151 + irinotecanExperimentalMM-151 given weekly, irinotecan 180 mg/m2 given once every two weeks
  • MM-151 + irinotecan

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of dose limiting toxicities (DLTs) within a cohort
Time Frame:2 years
Safety Issue:
Description:
Measure:Adverse event profile of MM-151 alone and in combination with irinotecan
Time Frame:2 years
Safety Issue:
Description:
Measure:Objective response to MM-151 alone and in combination with irinotecan based on RECIST
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Merrimack Pharmaceuticals

Trial Keywords

  • cancer
  • solid tumors
  • oncology
  • Phase I
  • EGFR
  • EGF receptor (ErbB1)
  • irinotecan

Last Updated

March 21, 2018