Trial record 1 of 1 for:    NCT01520389
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Safety Study of the Drug MM-151 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment

This study is currently recruiting participants.
Verified January 2014 by Merrimack Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01520389
First received: January 13, 2012
Last updated: January 27, 2014
Last verified: January 2014

January 13, 2012
January 27, 2014
January 2012
November 2014   (final data collection date for primary outcome 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 ] [ Designated as safety issue: Yes ]
To determine the 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 ]
Complete list of historical versions of study NCT01520389 on ClinicalTrials.gov Archive Site
  • Number of dose limiting toxicities (DLTs) within a cohort [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Adverse event profile of MM-151 alone and in combination with irinotecan [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Objective response to MM-151 alone and in combination with irinotecan based on RECIST [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 ]
  • To describe any objective response to MM-151 based on RECIST [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety Study of the Drug MM-151 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment
A Phase 1 and Pharmacologic Study of MM-151 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, evaluating MM-151 at varying dose levels and frequencies, and subsequently in combination with irinotecan.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced Solid Tumors
  • Colorectal Cancer
  • Squamous Cell Head and Neck Cancer
  • Non Small Cell Lung Cancer
  • Triple Negative Breast Cancer
  • Drug: MM-151
    MM-151
  • Drug: MM-151 + irinotecan
    MM-151 + irinotecan
    Other Name: camptosar
  • Experimental: MM-151 Dose Escalation
    MM-151 Dose escalation frequency - once weekly, once every two weeks, once every three weeks
    Intervention: Drug: MM-151
  • Experimental: MM-151 Expansion in KRAS wild type colorectal cancer
    MM-151 given weekly
    Intervention: Drug: MM-151
  • Experimental: MM-151 + irinotecan
    MM-151 given weekly, irinotecan 180 mg/m2 given once every two weeks
    Intervention: Drug: MM-151 + irinotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
115
March 2015
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
United States
 
NCT01520389
MM-151-01-01-01
Not Provided
Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Not Provided
Not Provided
Merrimack Pharmaceuticals
January 2014

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