Clinical trial NCT01520389: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Colorectal Cancer
Squamous Cell Head and Neck Cancer
Non Small Cell Lung Cancer
Triple Negative Breast Cancer
Keywords: cancer
solid tumors
oncology
Phase I
EGFR
EGF receptor (ErbB1)
irinotecan
Lead sponsor: Merrimack Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-01-30
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
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.
timeFrame: Two years
Secondary outcomes:
measure: Number of dose limiting toxicities (DLTs) within a cohort
timeFrame: 2 years
measure: Adverse event profile of MM-151 alone and in combination with irinotecan
timeFrame: 2 years
measure: Objective response to MM-151 alone and in combination with irinotecan based on RECIST
timeFrame: 2 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Lafayette
country: United States
facility: Horizon Oncology Research, Inc.
state: Indiana
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics, LLC (START)
state: Texas
Study officials:
References: