Phase I Safety Study of the Drug MM-121 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:July 2008
End Date:July 2011

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A Phase I and Pharmocologic Study of MM-121 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. Successive cohorts of three or more patients will be treated at escalating doses
until a maximum tolerated dose is identified. The study will initially explore a dosing
schedule every 7-days, which may be modified to longer intervals under certain
circumstances. Once the maximum tolerated dose or recommended Phase 2 dose is identified,
an Expansion Cohort will be enrolled at that dose to further characterize safety and to
explore pharmacodynamic endpoints. It is anticipated 2-3 study sites will participate in
this trial.


Inclusion Criteria:

- Patients must have histologically or cytologically confirmed advanced solid tumors
that have recurred or progressed following standard therapy, or that have 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-121
(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
We found this trial at
3
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Nashville,, Tennessee 37232
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Nashville,, TN
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333 Cottman Ave
Philadephia, Pennsylvania 19111
(215) 728-6900
Fox Chase Cancer Center Fox Chase has earned the prestigious designation from the National Cancer...
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Philadephia, PA
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