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.
Title
- Brief Title: Safety Study of the Drug MM-151 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment
- Official Title: A Phase 1 and Pharmacologic Study of MM-151 in Patients With Refractory Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
MM-151-01-01-01
- NCT ID:
NCT01520389
Conditions
- Advanced Solid Tumors
- Colorectal Cancer
- Squamous Cell Head and Neck Cancer
- Non Small Cell Lung Cancer
- Triple Negative Breast Cancer
Interventions
Drug | Synonyms | Arms |
---|
MM-151 | | MM-151 Dose Escalation |
MM-151 + irinotecan | camptosar | MM-151 + irinotecan |
Purpose
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.
Detailed 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.
Trial Arms
Name | Type | Description | Interventions |
---|
MM-151 Dose Escalation | Experimental | MM-151 Dose escalation frequency - once weekly, once every two weeks, once every three weeks | |
MM-151 Expansion in KRAS wild type colorectal cancer | Experimental | MM-151 given weekly | |
MM-151 + irinotecan | Experimental | MM-151 given weekly, irinotecan 180 mg/m2 given once every two weeks | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 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 |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Number of dose limiting toxicities (DLTs) within a cohort |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Measure: | Adverse event profile of MM-151 alone and in combination with irinotecan |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Measure: | Objective response to MM-151 alone and in combination with irinotecan based on RECIST |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Merrimack Pharmaceuticals |
Trial Keywords
- cancer
- solid tumors
- oncology
- Phase I
- EGFR
- EGF receptor (ErbB1)
- irinotecan
Last Updated
March 21, 2018