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NCT01520389
Safety Study of the Drug MM-151 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment
Archived
Phase 1
Description
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.
Target evidence in colorectal cancer
These drugs are NOT the drug used in this trial. This is published efficacy of OTHER drugs that hit the same molecular target, shown as context — it does not refer to this specific trial and does not confirm eligibility. Always review with your oncologist.
No documented evidence yet in our database for the target or drug of this trial. This section grows as new publications are processed.
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
Trial Information
NCT01520389
Archived
Phase 1
112 participants
Jan 2012
Locations4
United States (4)
University of Colorado Denver
Aurora, Colorado, 80045
Horizon Oncology Research, Inc.
Lafayette, Indiana, 47905
Roswell Park Cancer Institute
Buffalo, New York, 14263
South Texas Accelerated Research Therapeutics, LLC (START)
San Antonio, Texas, 78229