Breast Cancer Clinical Trial

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

Summary

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.

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Full 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.

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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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

112

Study ID:

NCT01520389

Recruitment Status:

Completed

Sponsor:

Merrimack Pharmaceuticals

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There are 4 Locations for this study

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University of Colorado Denver
Aurora Colorado, 80045, United States
Horizon Oncology Research, Inc.
Lafayette Indiana, 47905, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
South Texas Accelerated Research Therapeutics, LLC (START)
San Antonio Texas, 78229, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

112

Study ID:

NCT01520389

Recruitment Status:

Completed

Sponsor:


Merrimack Pharmaceuticals

How clear is this clinincal trial information?

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