Phase 1 Combination Study of MM-151 With MM-121, MM-141, or Trametinib
NCT ID: NCT02538627
Last Updated: 2017-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
5 participants
INTERVENTIONAL
2015-08-31
2016-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MM-151+MM-121 Dose Escalation
MM-151 and MM-121 dose escalation in lung, head and neck, and colorectal cancers
MM-151
MM-151
MM-121
MM-121
MM-151+ trametinib Dose Escalation
MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.
MM-151
MM-151
trametinib
trametininb
MM-151+MM-141 Dose Escalation
MM-151 and MM-141 dose escalation in lung, head and neck, and colorectal cancers
MM-151
MM-151
MM-141
MM-141
MM-151+trametinib Dose Escalation
MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.
MM-151
MM-151
trametinib
trametininb
Colorectal cancer Expansion
Doses established in part 1 of the study
MM-151
MM-151
MM-121
MM-121
MM-141
MM-141
trametinib
trametininb
Head and neck Expansion
Doses established in part 1 of the study
MM-151
MM-151
MM-121
MM-121
MM-141
MM-141
trametinib
trametininb
Interventions
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MM-151
MM-151
MM-121
MM-121
MM-141
MM-141
trametinib
trametininb
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be able to provide informed consent
* Willing 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 any study therapy). This applies to women of childbearing potential as well as fertile men and their partners
* Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy, up to CTCAE grade 1
* Patients must have either heregulin-positive cancer, cancer with RAS mutation, IGF-1 positive cancer, or RAS wild type cancer.
Exclusion Criteria
* Patients who have 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 (primary) or symptomatic CNS (primary or metastatic) malignancies; patients with CNS metastases who have undergone surgery or radiotherapy or who have been on a stable dose of corticosteroids for at least 2 weeks and whose disease is stable prior to the first scheduled day of dosing will be eligible for the trial.
* Patients who have received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of the study treatment.
18 Years
ALL
No
Sponsors
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Merrimack Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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University of Colorado
Aurora, Colorado, United States
Northside Hospital
Sandy Springs, Georgia, United States
Northwestern
Chicago, Illinois, United States
Washington University
St Louis, Missouri, United States
Vanderbilt
Nashville, Tennessee, United States
Countries
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Other Identifiers
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MM-151-01-01-02
Identifier Type: -
Identifier Source: org_study_id
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