A Phase 1 interventional study of MM-151 and MM-151 + irinotecan in Advanced Solid Tumors, Colorectal Cancer and Squamous Cell Head and Neck Cancer, sponsored by Merrimack Pharmaceuticals. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-21.
Sponsored by Merrimack Pharmaceuticals · Phase 1, Interventional, and Treatment
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.
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.
1,140 studies on the registry are indexed under Triple Negative Breast Neoplasms; 443 are open to participants now.
This study's enrollment of 112 is above the median of 61 across 982 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Merrimack Pharmaceuticals is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MM-151 Dose escalation frequency - once weekly, once every two weeks, once every three weeks
Drug: MM-151
MM-151 given weekly
Drug: MM-151
MM-151 given weekly, irinotecan 180 mg/m2 given once every two weeks
Drug: MM-151 + irinotecan
MM-151
MM-151 + irinotecan
Also known as: camptosar
Phase II dose of MM-151 alone and in combination with irinotecan based either on the maximum tolerated dose (MTD) or maximum dose of 18 mg/kg in patients with advanced solid malignancies.
Time frame: Two years
Number of dose limiting toxicities (DLTs) within a cohort
Time frame: 2 years
Adverse event profile of MM-151 alone and in combination with irinotecan
Time frame: 2 years
Objective response to MM-151 alone and in combination with irinotecan based on RECIST
Time frame: 2 years
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Triple Negative Breast Neoplasms→
Merrimack Pharmaceuticals