A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors

NCT01733004 — Phase 1, Completed, 42 participants, Merrimack Pharmaceuticals

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Registry	NCT01733004
Status	Completed
Phase	Phase 1
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	42 (Actual)
Sponsor	Merrimack Pharmaceuticals (Industry)
Conditions	Hepatocellular Carcinoma
Interventions	MM-141 (Drug)
Dates	start 2012-11-01, primary completion 2016-01-01, first posted 2012-11-26, last updated 2016-08-04
Locations	4 sites in United States, France

-Summary

This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-141 at varying dose levels and frequencies.

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+Arms and interventions

Arm	Type	Interventions	Description
Arm A	Experimental	Drug: MM-141	MM-141 monotherapy
Arm B	Experimental	Drug: MM-141	MM-141 and Everolimus
Arm C	Experimental	Drug: MM-141	MM-141 and Abraxane and Gemcitabine

MM-141 (Drug)

+Outcome measures

Primary outcomes

Severity and number of adverse events related to escalating doses of MM-141 [2 years]: Determine the Phase II dose based either on the maximum tolerated dose (MTD) or recommended dose in patients with advanced solid malignancies.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Advanced malignant solid tumors for which no curative therapy exists that has recurred or pgrogressed following standard therapy
* Eighteen years of age or above
* Able to understand and sign an informed consent (or have a legal representative who is able to do so)
* Measurable disease according to RECIST v1.1
* ECOG Performance Score of 0 or 1
* Adequate bone marrow, hepatic, renal and cardiac function
* 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 MM-141

Exclusion Criteria:

* Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing
* Symptomatic CNS disease
* Received other recent antitumor therapy
* Pregnant or breast feeding

+Locations (4)

Facility	City	Country	Status
	Marietta, Georgia	United States
	Boston, Massachusetts	United States
	Detroit, Michigan	United States
	Villejuif	France

+Investigators

Chrystal Louis, MD, MPH, Study director, Merrimack Pharmaceuticals