Phase 1 Combination Study of MM-151 With MM-121, MM-141, or Trametinib

NCT ID: NCT02538627

Last Updated: 2017-09-05

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-10-05

Brief Summary

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This is a Phase 1 open-label, dose-escalation trial using "3+3" design, evaluating MM-151 co-administration with MM-121, MM-141, and trametinib at varying dose levels.

Detailed Description

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This is a two-part Phase 1, non-randomized, open-label study of MM-151 plus MM-121, MM-141, or trametinib in patients with advanced, heregulin-positive lung, head and neck, and colorectal cancers. In part 1 of the study, cohorts of 3 or more patients will be treated at escalating doses of MM-151 in combination with MM-121, MM-141, and trametinib until a maximum tolerated combination dose for each combination is identified. In part 2 of the study, patients will be treated with the combination dose identified in part 1 of the study.

Conditions

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Colorectal Cancer Non-small Cell Lung Cancer Squamous Cell Carcinoma of the Head and Neck

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

MM-151

Intervention Type DRUG

MM-151

MM-121

Intervention Type DRUG

MM-121

MM-151+ trametinib Dose Escalation

MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.

Group Type EXPERIMENTAL

MM-151

Intervention Type DRUG

MM-151

trametinib

Intervention Type DRUG

trametininb

MM-151+MM-141 Dose Escalation

MM-151 and MM-141 dose escalation in lung, head and neck, and colorectal cancers

Group Type EXPERIMENTAL

MM-151

Intervention Type DRUG

MM-151

MM-141

Intervention Type DRUG

MM-141

MM-151+trametinib Dose Escalation

MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.

Group Type EXPERIMENTAL

MM-151

Intervention Type DRUG

MM-151

trametinib

Intervention Type DRUG

trametininb

Colorectal cancer Expansion

Doses established in part 1 of the study

Group Type EXPERIMENTAL

MM-151

Intervention Type DRUG

MM-151

MM-121

Intervention Type DRUG

MM-121

MM-141

Intervention Type DRUG

MM-141

trametinib

Intervention Type DRUG

trametininb

Head and neck Expansion

Doses established in part 1 of the study

Group Type EXPERIMENTAL

MM-151

Intervention Type DRUG

MM-151

MM-121

Intervention Type DRUG

MM-121

MM-141

Intervention Type DRUG

MM-141

trametinib

Intervention Type DRUG

trametininb

Interventions

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MM-151

MM-151

Intervention Type DRUG

MM-121

MM-121

Intervention Type DRUG

MM-141

MM-141

Intervention Type DRUG

trametinib

trametininb

Intervention Type DRUG

Other Intervention Names

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MEKINIST

Eligibility Criteria

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Inclusion Criteria

* Patients must be \>18 years of age
* 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 are pregnant or lactating
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merrimack Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Colorado

Aurora, Colorado, United States

Site Status

Northside Hospital

Sandy Springs, Georgia, United States

Site Status

Northwestern

Chicago, Illinois, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Vanderbilt

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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MM-151-01-01-02

Identifier Type: -

Identifier Source: org_study_id

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